Breast Cancer FemaleNCT03131440
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
A study testing Core, Support Calls and App+ in people with Breast Cancer Female and Physical Activity, run by Northwestern University at 1 site in United States.
Trial summary
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Physical Activity
- What is being tested?
- Core, Support Calls and App+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 17 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosed with Stage I-III breast cancer within the last 5 years
- Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
- English speaking
- Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
- Own a smartphone
- Have access to a computer with Internet
- Participants may be using adjuvant endocrine therapies.
- Willing to be waitlisted for future wave if current wave reaches capacity
Who cannot join
- -Women will be excluded if they report any of the following:
- Respiratory, joint or cardiovascular problems precluding physical activity
- Metastatic disease
- Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
- ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
- A prior cardiovascular event (i.e. stroke, myocardial infarction)
- Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
- Conditions
- Breast Cancer Female, Physical Activity
- Being tested
- Core, Support Calls, App+, Online gym, App notifications
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreBehavioural
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support CallsBehavioural
Participants will receive 6 bi-weekly phone calls from study staff.
App+Behavioural
Participants will receive "deluxe" version of smartphone app with additional features.
Online gymBehavioural
Participants will receive access to online exercise videos.
App notificationsBehavioural
Participants will receive motivational app notifications
BuddyBehavioural
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition #1 | Experimental | core, support calls Receives: Behavioral: Core; Behavioral: Support Calls |
| Experimental Condition #2 | Experimental | core, support calls, app+ Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+ |
| Experimental Condition #3 | Experimental | core, support calls, buddy Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: Buddy |
| Experimental Condition #4 | Experimental | core, support calls, online gym Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: Online gym |
| Experimental Condition #5 | Experimental | core, support calls, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App notifications |
| Experimental Condition #6 | Experimental | core, app+ Receives: Behavioral: Core; Behavioral: App+ |
| Experimental Condition #7 | Experimental | core, app+, buddy Receives: Behavioral: Core; Behavioral: App+; Behavioral: Buddy |
| Experimental Condition #8 | Experimental | core, app+, online gym Receives: Behavioral: Core; Behavioral: App+; Behavioral: Online gym |
| Experimental Condition #9 | Experimental | core, app+, app notifications Receives: Behavioral: Core; Behavioral: App+; Behavioral: App notifications |
| Experimental Condition #10 | Experimental | core, buddy Receives: Behavioral: Core; Behavioral: Buddy |
| Experimental Condition #11 | Experimental | core, buddy, online gym Receives: Behavioral: Core; Behavioral: Online gym; Behavioral: Buddy |
| Experimental Condition #12 | Experimental | core, buddy, app notifications Receives: Behavioral: Core; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #13 | Experimental | core, online gym Receives: Behavioral: Core; Behavioral: Online gym |
| Experimental Condition #14 | Experimental | core, online gym, app notifications Receives: Behavioral: Core; Behavioral: Online gym; Behavioral: App notifications |
| Experimental Condition #15 | Experimental | core, app notifications Receives: Behavioral: Core; Behavioral: App notifications |
| Experimental Condition #16 | Experimental | core, support calls, app+, buddy Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Buddy |
| Experimental Condition #17 | Experimental | core, support calls, app+, online gym Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Online gym |
| Experimental Condition #18 | Experimental | core, support calls, app+, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: App notifications |
| Experimental Condition #19 | Experimental | core, support calls, buddy, online gym Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: Online gym; Behavioral: Buddy |
| Experimental Condition #20 | Experimental | core, support calls, buddy, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #21 | Experimental | core, support calls, online gym, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: Online gym; Behavioral: App notifications |
| Experimental Condition #22 | Experimental | core, app+, buddy, online gym Receives: Behavioral: Core; Behavioral: App+; Behavioral: Online gym; Behavioral: Buddy |
| Experimental Condition #23 | Experimental | core, app+, buddy, online gym, app notifications Receives: Behavioral: Core; Behavioral: App+; Behavioral: Online gym; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #24 | Experimental | core, support calls, buddy, online gym, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: Online gym; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #25 | Experimental | core, buddy, online gym, app notifications Receives: Behavioral: Core; Behavioral: Online gym; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #26 | Experimental | core, app+, online gym, app notifications Receives: Behavioral: Core; Behavioral: App+; Behavioral: Online gym; Behavioral: App notifications |
| Experimental Condition #27 | Experimental | core, support calls, app+, buddy, online gym Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Online gym; Behavioral: Buddy |
| Experimental Condition #28 | Experimental | core, support calls, app+, buddy, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #29 | Experimental | core, support calls, app+, online gym, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Online gym; Behavioral: App notifications |
| Experimental Condition #30 | Experimental | core Receives: Behavioral: Core |
| Experimental Condition #31 | Experimental | core, app+, buddy, app notifications Receives: Behavioral: Core; Behavioral: App+; Behavioral: App notifications; Behavioral: Buddy |
| Experimental Condition #32 | Experimental | core, support calls, app+, buddy, online gym, app notifications Receives: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Online gym; Behavioral: App notifications; Behavioral: Buddy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Measured: 12 weeks
Participant Retention
Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100].
Measured: 12 weeks
Intervention Reach
Percentage of individuals randomized of those who were sent a study screening survey
Measured: Baseline
Secondary outcomes (24)
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Physical activity will be measured at baseline and at 12 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: Change from baseline to 12 weeks
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Physical activity will be measured at baseline and at 24 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: Change from baseline to 24 weeks
Change in Fatigue From Before to After a 12-Week Intervention
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Change from baseline to 12 weeks
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Change from baseline to 24 weeks
Change in Physical Function From Before to After a 12-Week Intervention
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Change from baseline to 12 weeks
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
Measured: Change from baseline to 24 weeks
Change in Depression From Before to After a 12-Week Intervention
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Change from baseline to 12 weeks
Change in Depression From Pre-Intervention to 24-week Follow-up
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Change from baseline to 24 weeks
Adherence to During the Full 24-Week Study Period
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
Measured: 24 weeks
Participant Retention at 24 Week Follow-up
Percentage of participants retained at 24 weeks of those randomized
Measured: 24 weeks
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
Measured: Change from baseline to 12 weeks
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Measured: Change from baseline to 24 weeks
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Measured: Change from baseline to 12 weeks
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.
Measured: Change from baseline to 24 weeks
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.
Measured: Change from baseline to 12 weeks
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.
Measured: Change from baseline to 24 weeks
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.
Measured: Change from baseline to 12 weeks
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.
Measured: Change from baseline to 24 weeks
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Measured: Change from baseline to 12 weeks
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.
Measured: Change from baseline to 24 weeks
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Measured: Change from baseline to 12 weeks
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Measured: Change from baseline to 24 weeks
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Measured: Change from baseline to 12 weeks
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start24 Apr 2017
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131440
- Sponsor's protocol ID
- K07CA196840
- Other IDs
- K07CA196840, R21CA219028-01A1
- Status last verified
- Feb 2023
- First submitted
- 18 Apr 2017
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.
Publications
Solk P, Song J, Reading J, Starikovsky J, Cullather E, Wang S, Hasanaj K, Morelli WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Frey J, Phillips SM. Feasibility and acceptability of the Fit2Thrive mHealth physical activity promotion intervention components in breast cancer survivors. Transl Behav Med. 2025 Jan 16;15(1):ibaf033. doi: 10.1093/tbm/ibaf033.
PubMed 40795071Solk P, Song J, Welch WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Freeman H, Starikovsky J, Mishory A, Alexander J, Wolter M, Carden L, Phillips SM. Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial. Ann Behav Med. 2023 Aug 21;57(9):765-776. doi: 10.1093/abm/kaad024.
PubMed 37203237
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03131440
- Acronym / sponsor ID
- K07CA196840
- Conditions
- Breast Cancer Female, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Posted 10 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 32
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition #1 | Experimental | Behavioral: Core, Behavioral: Support Callscore, support calls |
| Experimental Condition #2 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+core, support calls, app+ |
| Experimental Condition #3 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: Buddycore, support calls, buddy |
| Experimental Condition #4 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: Online gymcore, support calls, online gym |
| Experimental Condition #5 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App notificationscore, support calls, app notifications |
| Experimental Condition #6 | Experimental | Behavioral: Core, Behavioral: App+core, app+ |
| Experimental Condition #7 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: Buddycore, app+, buddy |
| Experimental Condition #8 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: Online gymcore, app+, online gym |
| Experimental Condition #9 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: App notificationscore, app+, app notifications |
| Experimental Condition #10 | Experimental | Behavioral: Core, Behavioral: Buddycore, buddy |
| Experimental Condition #11 | Experimental | Behavioral: Core, Behavioral: Online gym, Behavioral: Buddycore, buddy, online gym |
| Experimental Condition #12 | Experimental | Behavioral: Core, Behavioral: App notifications, Behavioral: Buddycore, buddy, app notifications |
| Experimental Condition #13 | Experimental | Behavioral: Core, Behavioral: Online gymcore, online gym |
| Experimental Condition #14 | Experimental | Behavioral: Core, Behavioral: Online gym, Behavioral: App notificationscore, online gym, app notifications |
| Experimental Condition #15 | Experimental | Behavioral: Core, Behavioral: App notificationscore, app notifications |
| Experimental Condition #16 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: Buddycore, support calls, app+, buddy |
| Experimental Condition #17 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: Online gymcore, support calls, app+, online gym |
| Experimental Condition #18 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: App notificationscore, support calls, app+, app notifications |
| Experimental Condition #19 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: Online gym, Behavioral: Buddycore, support calls, buddy, online gym |
| Experimental Condition #20 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App notifications, Behavioral: Buddycore, support calls, buddy, app notifications |
| Experimental Condition #21 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: Online gym, Behavioral: App notificationscore, support calls, online gym, app notifications |
| Experimental Condition #22 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: Online gym, Behavioral: Buddycore, app+, buddy, online gym |
| Experimental Condition #23 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: Online gym, Behavioral: App notifications, Behavioral: Buddycore, app+, buddy, online gym, app notifications |
| Experimental Condition #24 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: Online gym, Behavioral: App notifications, Behavioral: Buddycore, support calls, buddy, online gym, app notifications |
| Experimental Condition #25 | Experimental | Behavioral: Core, Behavioral: Online gym, Behavioral: App notifications, Behavioral: Buddycore, buddy, online gym, app notifications |
| Experimental Condition #26 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: Online gym, Behavioral: App notificationscore, app+, online gym, app notifications |
| Experimental Condition #27 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: Online gym, Behavioral: Buddycore, support calls, app+, buddy, online gym |
| Experimental Condition #28 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: App notifications, Behavioral: Buddycore, support calls, app+, buddy, app notifications |
| Experimental Condition #29 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: Online gym, Behavioral: App notificationscore, support calls, app+, online gym, app notifications |
| Experimental Condition #30 | Experimental | Behavioral: Corecore |
| Experimental Condition #31 | Experimental | Behavioral: Core, Behavioral: App+, Behavioral: App notifications, Behavioral: Buddycore, app+, buddy, app notifications |
| Experimental Condition #32 | Experimental | Behavioral: Core, Behavioral: Support Calls, Behavioral: App+, Behavioral: Online gym, Behavioral: App notifications, Behavioral: Buddycore, support calls, app+, buddy, online gym, app notifications |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with Stage I-III breast cancer within the last 5 years
- Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
- English speaking
- Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
- Own a smartphone
Key exclusion criteria (7 listed)
- Respiratory, joint or cardiovascular problems precluding physical activity
- Metastatic disease
- Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
- A prior cardiovascular event (i.e. stroke, myocardial infarction)
- Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
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 |
|---|---|---|
| CoreThe core intervention will include educational materials, access to a basic smartphone app and a Fitbit. | Behavioural | Experimental Condition #1, Experimental Condition #10, Experimental Condition #11, Experimental Condition #12, Experimental Condition #13, Experimental Condition #14, Experimental Condition #15, Experimental Condition #16, Experimental Condition #17, Experimental Condition #18, Experimental Condition #19, Experimental Condition #2, Experimental Condition #20, Experimental Condition #21, Experimental Condition #22, Experimental Condition #23, Experimental Condition #24, Experimental Condition #25, Experimental Condition #26, Experimental Condition #27, Experimental Condition #28, Experimental Condition #29, Experimental Condition #3, Experimental Condition #30, Experimental Condition #31, Experimental Condition #32, Experimental Condition #4, Experimental Condition #5, Experimental Condition #6, Experimental Condition #7, Experimental Condition #8, Experimental Condition #9 |
| Support CallsParticipants will receive 6 bi-weekly phone calls from study staff. | Behavioural | Experimental Condition #1, Experimental Condition #16, Experimental Condition #17, Experimental Condition #18, Experimental Condition #19, Experimental Condition #2, Experimental Condition #20, Experimental Condition #21, Experimental Condition #24, Experimental Condition #27, Experimental Condition #28, Experimental Condition #29, Experimental Condition #3, Experimental Condition #32, Experimental Condition #4, Experimental Condition #5 |
| App+Participants will receive "deluxe" version of smartphone app with additional features. | Behavioural | Experimental Condition #16, Experimental Condition #17, Experimental Condition #18, Experimental Condition #2, Experimental Condition #22, Experimental Condition #23, Experimental Condition #26, Experimental Condition #27, Experimental Condition #28, Experimental Condition #29, Experimental Condition #31, Experimental Condition #32, Experimental Condition #6, Experimental Condition #7, Experimental Condition #8, Experimental Condition #9 |
| Online gymParticipants will receive access to online exercise videos. | Behavioural | Experimental Condition #11, Experimental Condition #13, Experimental Condition #14, Experimental Condition #17, Experimental Condition #19, Experimental Condition #21, Experimental Condition #22, Experimental Condition #23, Experimental Condition #24, Experimental Condition #25, Experimental Condition #26, Experimental Condition #27, Experimental Condition #29, Experimental Condition #32, Experimental Condition #4, Experimental Condition #8 |
| App notificationsParticipants will receive motivational app notifications | Behavioural | Experimental Condition #12, Experimental Condition #14, Experimental Condition #15, Experimental Condition #18, Experimental Condition #20, Experimental Condition #21, Experimental Condition #23, Experimental Condition #24, Experimental Condition #25, Experimental Condition #26, Experimental Condition #28, Experimental Condition #29, Experimental Condition #31, Experimental Condition #32, Experimental Condition #5, Experimental Condition #9 |
| BuddyParticipants will choose a buddy to receive a Fitbit and support them during the intervention. | Behavioural | Experimental Condition #10, Experimental Condition #11, Experimental Condition #12, Experimental Condition #16, Experimental Condition #19, Experimental Condition #20, Experimental Condition #22, Experimental Condition #23, Experimental Condition #24, Experimental Condition #25, Experimental Condition #27, Experimental Condition #28, Experimental Condition #3, Experimental Condition #31, Experimental Condition #32, Experimental Condition #7 |
Primary outcome
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Time frame: 12 weeks
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Participant Retention
Time frame: 12 weeks
Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100].
Intervention Reach
Time frame: Baseline
Percentage of individuals randomized of those who were sent a study screening survey
24 secondary outcomes
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Time frame: Change from baseline to 12 weeks
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Time frame: Change from baseline to 24 weeks
Change in Fatigue From Before to After a 12-Week Intervention
Time frame: Change from baseline to 12 weeks
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Time frame: Change from baseline to 24 weeks
Change in Physical Function From Before to After a 12-Week Intervention
Time frame: Change from baseline to 12 weeks
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Time frame: Change from baseline to 24 weeks
Change in Depression From Before to After a 12-Week Intervention
Time frame: Change from baseline to 12 weeks
Change in Depression From Pre-Intervention to 24-week Follow-up
Time frame: Change from baseline to 24 weeks
Adherence to During the Full 24-Week Study Period
Time frame: 24 weeks
Participant Retention at 24 Week Follow-up
Time frame: 24 weeks
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Time frame: Change from baseline to 24 weeks
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Time frame: Change from baseline to 24 weeks
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
Time frame: Change from baseline to 24 weeks
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
Time frame: Change from baseline to 24 weeks
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Time frame: Change from baseline to 24 weeks
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Time frame: Change from baseline to 24 weeks
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
Time frame: Change from baseline to 12 weeks
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
Time frame: Change from baseline to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40795071Solk P, Song J, Reading J, Starikovsky J, Cullather E, Wang S, Hasanaj K, Morelli WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Frey J, Phillips SM. Feasibility and acceptability of the Fit2Thrive mHealth physical activity promotion intervention components in breast cancer survivors. Transl Behav Med. 2025 Jan 16;15(1):ibaf033. doi: 10.1093/tbm/ibaf033.
- Derived from this study: PubMed 37203237Solk P, Song J, Welch WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Freeman H, Starikovsky J, Mishory A, Alexander J, Wolter M, Carden L, Phillips SM. Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial. Ann Behav Med. 2023 Aug 21;57(9):765-776. doi: 10.1093/abm/kaad024.
- Individual participant dataSharing planned: Yes. Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Support Calls and App+ in people with Breast Cancer Female and Physical Activity, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 10 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to a 12 Week Technology Supported Physical Activity Intervention (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT03131440, which also lists 2 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 10 Mar 2023.