Breast CancerF2TMindNCT05931874
Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
A study testing Core Intervention, E-Coach and Buddy in people with Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Core Intervention, E-Coach and Buddy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For BCS
- Female, age 18 years or older
- Stage I-III breast cancer diagnosis within the past 5 years
- Diagnosis of cancer between 18-39 years and within the past 5 years
- ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
- Self-report engagement in <60 min/week of MVPA
Show all 17Show fewer
- Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary care physician or oncologist
- Internet access and smartphone ownership
- Fluency in spoken and written English
- Willingness to find a buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 24-week study), if assigned to that condition
- For "Buddies"
- Friend, co-worker, caregiver or family member of a participating BCS
- Age 18 years or older
- Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care physician
- Internet access and smartphone ownership
- Fluency in spoken and written English
- Willingness to share their Fitbit data with the study team
Who cannot join
- Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
- Currently pregnant or plans to become pregnant
- Plans to move out of the United States in next 18 months
- Current enrollment in another dietary or physical activity trial
- Inability to provide informed consent
- Prisoners or other detained individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Read more
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Read the detailed description
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Research participants will be identified and recruited at Robert H. Lurie Cancer Center (RHLCC) at Northwestern University (NU). All BCS and Buddies will complete an initial 10-15 minute eligibility screening online, over the phone, or in-person. The study RA will obtain informed consent and HIPAA authorization from eligible participants according to IRB approved procedures.
Assessments. After informed consent completion, the NU study team will send participants an email with an individual, secure link to study questionnaires and notification that an ActiGraph accelerometer packet has been mailed. Participants will be asked to complete the questionnaire within 1 week of receipt. BCS will be provided with detailed written instructions for how to wear the ActiGraph.
Randomization and Study Orientation. After completing baseline assessments, BCS will be randomized to each group using computer-generated randomly permuted blocks. After randomization, the NU study team will send the participant an intervention packet which will include the Fitbit, Fitbit instructions, instructions and a QR code to download the study app, and instructions specific to each condition to which they are assigned. The participant will also be scheduled for an orientation phone or web call with study staff to go over the contents of the intervention packet and expectations of participation for each component in greater detail.
Intervention Components
Core Intervention (Fitbit + Study App). All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit AltaHR (or similar) and the study self-monitoring app. Participants will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the 48-week study period. The core study app will support BCS to increase their MVPA. Participants will be provided with a weekly MVPA goal to build efficacy and ensure safe progression towards the overall goal of 150 minutes per week. Participants will be instructed to self-monitor progress towards these goals via feedback on Fitbit Alta HR and the daily, weekly and monthly progress information provided in the study app.
Buddy. Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The study team will reach out to the buddy via an email containing a description of the expectations of the buddy and a link to complete online screening. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition. The buddy will be expected to attend a 15-minute group orientation call online and to listen to four 10-15 minute podcasts (one every 3 weeks) during the 24 week intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support.
E-coaching. Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance. The coach will respond within 24 hours (weekdays) to 48 hours (weekends), maximum.
General Mindfulness Training. Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app.
MVPA-Specific Mindfulness Training. Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recording will be accessed via the study app.
Follow-up. Participants will be instructed to maintain their MVPA during the 24-week follow-up period. They will have access to all materials to which they were assigned to less any direct contact from the study team.
- Conditions
- Breast Cancer
- Being tested
- Core Intervention, E-Coach, Buddy, General Mindfulness Training, MVPA-Specific Mindfulness Training
- Keywords
- breast cancer, e-health, physical activity, mindfulness
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core InterventionBehavioural
All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit Alta HR (or similar) and the study self-monitoring app.
Participants will be provided with the Fitbit Alta HR. They will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the study. The Fitbit measures PA intensity, steps, and heart rate, and it syncs directly with the Ftibit app on the smartphone which will ill automatically sync with the study app and provide Fitbit data to the study team in real-time.
The core study app will support BCS to increase their MVPA. The app will also contain educational information on MVPA and effective behavior change strategies for building self-efficacy, overcoming barriers, enhancing facilitators, setting realistic outcome expectations, and self-regulatory skill-building (i.e., reviewing progress, goal setting, action-planning and coping with disruptions).
E-CoachBehavioural
Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. Text message protocols will be informed by the investigators' previous experience using telephone coaching to promote MVPA in cancer survivors. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance.
BuddyBehavioural
Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition.
The study app include a buddy module where the buddy and participant can view each other's progress. The buddy will be expected to attend a 15-30 minute group orientation call and listen to four 10-15 minute podcast (one every 3 weeks) during the first 24 weeks of the intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support.
General Mindfulness TrainingBehavioural
Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app.
MVPA-Specific Mindfulness TrainingBehavioural
Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recordings will be accessed via the study app.
| Study group | Role | What they receive |
|---|---|---|
| Exp Condition 1 | Experimental | Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 2 | Active comparator | Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 3 | Active comparator | Research participant receives the Core Intervention + E-Coach + Buddy Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy |
| Exp Condition 4 | Active comparator | Research participant receives the Core Intervention + E-Coach Receives: Behavioral: Core Intervention; Behavioral: E-Coach |
| Exp Condition 5 | Active comparator | Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy; Behavioral: General Mindfulness Training |
| Exp Condition 6 | Active comparator | Research participant receives the Core Intervention + E-Coach + General Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: General Mindfulness Training |
| Exp Condition 7 | Active comparator | Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 8 | Active comparator | Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 9 | Active comparator | Research participant receives the Core Intervention + General Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: Buddy; Behavioral: General Mindfulness Training |
| Exp Condition 10 | Active comparator | Research participant receives the Core Intervention + General Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: General Mindfulness Training |
| Exp Condition 11 | Active comparator | Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: Buddy; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 12 | Active comparator | Research participant receives the Core Intervention + MVPA Specific Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 13 | Active comparator | Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: Buddy; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 14 | Active comparator | Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training |
| Exp Condition 15 | Active comparator | Research participant receives the Core Intervention + Buddy Receives: Behavioral: Core Intervention; Behavioral: Buddy |
| Exp Condition 16 | Active comparator | Research participant receives the Core Intervention Receives: Behavioral: Core Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.
Measured: 48 weeks
Secondary outcomes (11)
Anxiety in breast cancer survivors
Symptom burden of anxiety will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a.
Measured: 48 weeks
Depression in breast cancer survivors
Symptom burden of depression will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a.
Measured: 48 weeks
Fatigue in breast cancer survivors
Symptom burden of fatigue will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a.
Measured: 48 weeks
Physical Function in breast cancer survivors
Physical function will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Physical Function - Short Form 20a.
Measured: 48 weeks
Sleep Disturbance in breast cancer survivors
Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8a.
Measured: 48 weeks
Sleep Impairment in breast cancer survivors
Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a.
Measured: 48 weeks
Applied Cognition Abilities in breast cancer survivors
Symptom burden on applied cognitive abilities will be measured at baseline, 24 and 48 weeks using the PROMIS v1.0-Applied Cognition-Abilities-Short Form 8a.
Measured: 48 weeks
Leisure Time Physical Activity in breast cancer survivors
Leisure time physical activity will be measured at baseline, 24 and 48 weeks using the Godin Leisure Time Exercise Questionnaire Physical Activity.
This is a measure of self-reported physical activity participation. Participants report "times per week" they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the "average duration each time you exercised (in minutes)" for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome.
Measured: 48 weeks
Light Intensity Physical Activity
Light intensity physical activity will be measured at baseline and at 24 and 48 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Measured: 48 weeks
Sedentary Time
Sedentary time will be measured at baseline and at 24 and 48 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Measured: 48 weeks
Sleep Duration
Sleep duration will be measured at baseline and at 24 and 48 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days on their wrist while they sleep.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start24 Mar 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The four Intervention components that are candidates for inclusion in the optimized intervention, each with 2 possible levels, will be tested in a 24-week intervention with a 24-week follow-up using a MOST approach. The effects of the four individual intervention components and their combinations will be examined via a full factorial experiment. The investigators chose a factorial experimental design because these designs have two characteristics essential to the success of MOST. They: a) separate component effects enabling the estimation of the main effect of each candidate component and interactions between components and b) are more economical compared to alternative designs because they often require substantially fewer subjects to achieve the same power and use less resources. The investigators are using a full factorial experiment with 2\^4=16 experimental conditions.
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Siobhan M Phillips, Northwestern University
- Investigators
- Siobhan M Phillips, PhD, MPH, Principal investigator, Northwestern UniversityDavid E Victorson, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931874
- Sponsor's protocol ID
- NU 22CC05
- Other IDs
- R01CA266178
- Acronym
- F2TMind
- Status last verified
- Jun 2026
- First submitted
- 24 May 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.
PubMed 31184787Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.
PubMed 20411366McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
PubMed 16818906Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
PubMed 20052559Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.
PubMed 22570317Arem H, Mama SK, Duan X, Rowland JH, Bellizzi KM, Ehlers DK. Prevalence of Healthy Behaviors among Cancer Survivors in the United States: How Far Have We Come? Cancer Epidemiol Biomarkers Prev. 2020 Jun;29(6):1179-1187. doi: 10.1158/1055-9965.EPI-19-1318. Epub 2020 May 14.
PubMed 32409489Thraen-Borowski KM, Gennuso KP, Cadmus-Bertram L. Accelerometer-derived physical activity and sedentary time by cancer type in the United States. PLoS One. 2017 Aug 14;12(8):e0182554. doi: 10.1371/journal.pone.0182554. eCollection 2017.
PubMed 28806753Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Fieuws S, Lefevre J, Philippaerts R, Truijen S, Neven P, Christiaens MR. Physical activity levels after treatment for breast cancer: one-year follow-up. Breast Cancer Res Treat. 2010 Sep;123(2):417-25. doi: 10.1007/s10549-010-0997-6. Epub 2010 Jun 27.
PubMed 20582717Charlier C, Van Hoof E, Pauwels E, Lechner L, Spittaels H, De Bourdeaudhuij I. The contribution of general and cancer-related variables in explaining physical activity in a breast cancer population 3 weeks to 6 months post-treatment. Psychooncology. 2013 Jan;22(1):203-11. doi: 10.1002/pon.2079. Epub 2011 Oct 5.
PubMed 22052746Irwin ML, Crumley D, McTiernan A, Bernstein L, Baumgartner R, Gilliland FD, Kriska A, Ballard-Barbash R. Physical activity levels before and after a diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003 Apr 1;97(7):1746-57. doi: 10.1002/cncr.11227.
PubMed 12655532Phillips SM, McAuley E. Social cognitive influences on physical activity participation in long-term breast cancer survivors. Psychooncology. 2013 Apr;22(4):783-91. doi: 10.1002/pon.3074. Epub 2012 Mar 26.
PubMed 22451113Thorsen L, Courneya KS, Stevinson C, Fossa SD. A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Support Care Cancer. 2008 Sep;16(9):987-97. doi: 10.1007/s00520-008-0411-7. Epub 2008 Feb 15.
PubMed 18274783Stevinson C, Tonkin K, Capstick V, Schepansky A, Ladha AB, Valance JK, Faught W, Steed H, Courneya KS. A population-based study of the determinants of physical activity in ovarian cancer survivors. J Phys Act Health. 2009 May;6(3):339-46. doi: 10.1123/jpah.6.3.339.
PubMed 19564663Kampshoff CS, Jansen F, van Mechelen W, May AM, Brug J, Chinapaw MJ, Buffart LM. Determinants of exercise adherence and maintenance among cancer survivors: a systematic review. Int J Behav Nutr Phys Act. 2014 Jul 2;11:80. doi: 10.1186/1479-5868-11-80.
PubMed 24989069Valle CG, Tate DF. Engagement of young adult cancer survivors within a Facebook-based physical activity intervention. Transl Behav Med. 2017 Dec;7(4):667-679. doi: 10.1007/s13142-017-0483-3.
PubMed 28374211
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05931874
- Acronym / sponsor ID
- F2TMind / NU 22CC05
- Conditions
- Breast Cancer
- Keywords
- breast cancer, e-health, physical activity, mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Detailed description
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Research participants will be identified and recruited at Robert H. Lurie Cancer Center (RHLCC) at Northwestern University (NU). All BCS and Buddies will complete an initial 10-15 minute eligibility screening online, over the phone, or in-person. The study RA will obtain informed consent and HIPAA authorization from eligible participants according to IRB approved procedures.
Assessments. After informed consent completion, the NU study team will send participants an email with an individual, secure link to study questionnaires and notification that an ActiGraph accelerometer packet has been mailed. Participants will be asked to complete the questionnaire within 1 week of receipt. BCS will be provided with detailed written instructions for how to wear the ActiGraph.
Randomization and Study Orientation. After completing baseline assessments, BCS will be randomized to each group using computer-generated randomly permuted blocks. After randomization, the NU study team will send the participant an intervention packet which will include the Fitbit, Fitbit instructions, instructions and a QR code to download the study app, and instructions specific to each condition to which they are assigned. The participant will also be scheduled for an orientation phone or web call with study staff to go over the contents of the intervention packet and expectations of participation for each component in greater detail.
Intervention Components
Core Intervention (Fitbit + Study App). All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit AltaHR (or similar) and the study self-monitoring app. Participants will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the 48-week study period. The core study app will support BCS to increase their MVPA. Participants will be provided with a weekly MVPA goal to build efficacy and ensure safe progression towards the overall goal of 150 minutes per week. Participants will be instructed to self-monitor progress towards these goals via feedback on Fitbit Alta HR and the daily, weekly and monthly progress information provided in the study app.
Buddy. Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The study team will reach out to the buddy via an email containing a description of the expectations of the buddy and a link to complete online screening. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition. The buddy will be expected to attend a 15-minute group orientation call online and to listen to four 10-15 minute podcasts (one every 3 weeks) during the 24 week intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support.
E-coaching. Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance. The coach will respond within 24 hours (weekdays) to 48 hours (weekends), maximum.
General Mindfulness Training. Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app.
MVPA-Specific Mindfulness Training. Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recording will be accessed via the study app.
Follow-up. Participants will be instructed to maintain their MVPA during the 24-week follow-up period. They will have access to all materials to which they were assigned to less any direct contact from the study team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- The four Intervention components that are candidates for inclusion in the optimized intervention, each with 2 possible levels, will be tested in a 24-week intervention with a 24-week follow-up using a MOST approach. The effects of the four individual intervention components and their combinations will be examined via a full factorial experiment. The investigators chose a factorial experimental design because these designs have two characteristics essential to the success of MOST. They: a) separate component effects enabling the estimation of the main effect of each candidate component and interactions between components and b) are more economical compared to alternative designs because they often require substantially fewer subjects to achieve the same power and use less resources. The investigators are using a full factorial experiment with 2^4=16 experimental conditions.
| Arm | Type | Receives |
|---|---|---|
| Exp Condition 1 | Experimental | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: Buddy, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy |
| Exp Condition 2 | Active comparator | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training |
| Exp Condition 3 | Active comparator | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: BuddyResearch participant receives the Core Intervention + E-Coach + Buddy |
| Exp Condition 4 | Active comparator | Behavioral: Core Intervention, Behavioral: E-CoachResearch participant receives the Core Intervention + E-Coach |
| Exp Condition 5 | Active comparator | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: Buddy, Behavioral: General Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy |
| Exp Condition 6 | Active comparator | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: General Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training |
| Exp Condition 7 | Active comparator | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: Buddy, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy |
| Exp Condition 8 | Active comparator | Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training |
| Exp Condition 9 | Active comparator | Behavioral: Core Intervention, Behavioral: Buddy, Behavioral: General Mindfulness TrainingResearch participant receives the Core Intervention + General Mindfulness Training + Buddy |
| Exp Condition 10 | Active comparator | Behavioral: Core Intervention, Behavioral: General Mindfulness TrainingResearch participant receives the Core Intervention + General Mindfulness Training |
| Exp Condition 11 | Active comparator | Behavioral: Core Intervention, Behavioral: Buddy, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy |
| Exp Condition 12 | Active comparator | Behavioral: Core Intervention, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + MVPA Specific Mindfulness Training |
| Exp Condition 13 | Active comparator | Behavioral: Core Intervention, Behavioral: Buddy, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy |
| Exp Condition 14 | Active comparator | Behavioral: Core Intervention, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training |
| Exp Condition 15 | Active comparator | Behavioral: Core Intervention, Behavioral: BuddyResearch participant receives the Core Intervention + Buddy |
| Exp Condition 16 | Active comparator | Behavioral: Core InterventionResearch participant receives the Core Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- For BCS
- Female, age 18 years or older
- Stage I-III breast cancer diagnosis within the past 5 years
- Diagnosis of cancer between 18-39 years and within the past 5 years
- ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
Key exclusion criteria (6 listed)
- Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
- Currently pregnant or plans to become pregnant
- Plans to move out of the United States in next 18 months
- Current enrollment in another dietary or physical activity trial
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core InterventionAll participants will receive a low-resource self-monitoring intervention consisting of the Fitbit Alta HR (or similar) and the study self-monitoring app. Participants will be provided with the Fitbit Alta HR. They will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the study. The Fitbit measures PA intensity, steps, and heart rate, and it syncs directly with the Ftibit app on the smartphone which will ill automatically sync with the study app and provide Fitbit data to the study team in real-time. The core study app will support BCS to increase their MVPA. The app will also contain educational information on MVPA and effective behavior change strategies for building self-efficacy, overcoming barriers, enhancing facilitators, setting realistic outcome expectations, and self-regulatory skill-building (i.e., reviewing progress, goal setting, action-planning and coping with disruptions). | Behavioural | Exp Condition 1, Exp Condition 10, Exp Condition 11, Exp Condition 12, Exp Condition 13, Exp Condition 14, Exp Condition 15, Exp Condition 16, Exp Condition 2, Exp Condition 3, Exp Condition 4, Exp Condition 5, Exp Condition 6, Exp Condition 7, Exp Condition 8, Exp Condition 9 |
| E-CoachParticipants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. Text message protocols will be informed by the investigators' previous experience using telephone coaching to promote MVPA in cancer survivors. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance. | Behavioural | Exp Condition 1, Exp Condition 2, Exp Condition 3, Exp Condition 4, Exp Condition 5, Exp Condition 6, Exp Condition 7, Exp Condition 8 |
| BuddyParticipants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition. The study app include a buddy module where the buddy and participant can view each other's progress. The buddy will be expected to attend a 15-30 minute group orientation call and listen to four 10-15 minute podcast (one every 3 weeks) during the first 24 weeks of the intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support. | Behavioural | Exp Condition 1, Exp Condition 11, Exp Condition 13, Exp Condition 15, Exp Condition 3, Exp Condition 5, Exp Condition 7, Exp Condition 9 |
| General Mindfulness TrainingParticipants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app. | Behavioural | Exp Condition 1, Exp Condition 10, Exp Condition 13, Exp Condition 14, Exp Condition 2, Exp Condition 5, Exp Condition 6, Exp Condition 9 |
| MVPA-Specific Mindfulness TrainingParticipants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recordings will be accessed via the study app. | Behavioural | Exp Condition 1, Exp Condition 11, Exp Condition 12, Exp Condition 13, Exp Condition 14, Exp Condition 2, Exp Condition 7, Exp Condition 8 |
Primary outcome
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
Time frame: 48 weeks
Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.
11 secondary outcomes
Anxiety in breast cancer survivors
Time frame: 48 weeks
Depression in breast cancer survivors
Time frame: 48 weeks
Fatigue in breast cancer survivors
Time frame: 48 weeks
Physical Function in breast cancer survivors
Time frame: 48 weeks
Sleep Disturbance in breast cancer survivors
Time frame: 48 weeks
Sleep Impairment in breast cancer survivors
Time frame: 48 weeks
Applied Cognition Abilities in breast cancer survivors
Time frame: 48 weeks
Leisure Time Physical Activity in breast cancer survivors
Time frame: 48 weeks
Light Intensity Physical Activity
Time frame: 48 weeks
Sedentary Time
Time frame: 48 weeks
Sleep Duration
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 31184787Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.
- Background: PubMed 20411366Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.
- Background: PubMed 16818906McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
- Background: PubMed 20052559Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
- Background: PubMed 22570317Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.
- Background: PubMed 32409489Arem H, Mama SK, Duan X, Rowland JH, Bellizzi KM, Ehlers DK. Prevalence of Healthy Behaviors among Cancer Survivors in the United States: How Far Have We Come? Cancer Epidemiol Biomarkers Prev. 2020 Jun;29(6):1179-1187. doi: 10.1158/1055-9965.EPI-19-1318. Epub 2020 May 14.
- Background: PubMed 28806753Thraen-Borowski KM, Gennuso KP, Cadmus-Bertram L. Accelerometer-derived physical activity and sedentary time by cancer type in the United States. PLoS One. 2017 Aug 14;12(8):e0182554. doi: 10.1371/journal.pone.0182554. eCollection 2017.
- Background: PubMed 20582717Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Fieuws S, Lefevre J, Philippaerts R, Truijen S, Neven P, Christiaens MR. Physical activity levels after treatment for breast cancer: one-year follow-up. Breast Cancer Res Treat. 2010 Sep;123(2):417-25. doi: 10.1007/s10549-010-0997-6. Epub 2010 Jun 27.
- Background: PubMed 22052746Charlier C, Van Hoof E, Pauwels E, Lechner L, Spittaels H, De Bourdeaudhuij I. The contribution of general and cancer-related variables in explaining physical activity in a breast cancer population 3 weeks to 6 months post-treatment. Psychooncology. 2013 Jan;22(1):203-11. doi: 10.1002/pon.2079. Epub 2011 Oct 5.
- Background: PubMed 12655532Irwin ML, Crumley D, McTiernan A, Bernstein L, Baumgartner R, Gilliland FD, Kriska A, Ballard-Barbash R. Physical activity levels before and after a diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003 Apr 1;97(7):1746-57. doi: 10.1002/cncr.11227.
- Background: PubMed 22451113Phillips SM, McAuley E. Social cognitive influences on physical activity participation in long-term breast cancer survivors. Psychooncology. 2013 Apr;22(4):783-91. doi: 10.1002/pon.3074. Epub 2012 Mar 26.
- Background: PubMed 18274783Thorsen L, Courneya KS, Stevinson C, Fossa SD. A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Support Care Cancer. 2008 Sep;16(9):987-97. doi: 10.1007/s00520-008-0411-7. Epub 2008 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhan M Phillips, PhD, MPH principal investigator
Northwestern University
David E Victorson, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Intervention, E-Coach and Buddy in people with Breast Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931874, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.