Breast NeoplasmsPACTNCT04562987
The Patterns of Activity and Cognition During Treatment (PACT) Study
A study testing Physical Activity in people with Breast Neoplasms and Breast Cancer Female, run by University of Nebraska at 1 site in United States.
Trial summary
Aim 1: This pilot study tests the feasibility and acceptability of a mobile app-based behavioral intervention in 40 women receiving chemotherapy for breast cancer. Participants will be randomized to receive app components following a 2x2 factorial design. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged 21 years or older
- First, primary diagnosis of Stage I-III breast cancer
- Scheduled to receive chemotherapy for 3-6 months. While evidence suggests declines in cognition and brain health due to cancer may be evident both in women who receive and who do not receive chemotherapy, those receiving chemotherapy consistently experience the greatest changes.
- Has received no more than one cycle of chemotherapy
- Agree to be randomized to one of the intervention components
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- Owns an Android or iPhone smartphone
- Fitbit specific criteria:
- Compatible mobile device, laptop computer, or desktop computer
- Willingness to continuously wear the Fitbit device during waking hours for the duration of the study period. Individuals not willing to wear the Fitbit during sleep will be eligible to participate.
- Willingness and ability to charge the Fitbit device at home every 3-4 days and synchronize the Fitbit device multiple times daily.
- English reading and speaking
- Receive physician's clearance to participate in an exercise program
- Provide written informed consent to participate in the study
- No history or evidence of dementia (score >21 on the Modified Telephone Interview for Cognitive Status [TICS-M].73
Who cannot join
- Males. Breast cancer is often classified specifically as female breast cancer, as 99% of cases occur in women. Our small sample size does not statistically justify the inclusion of males in this study. As such, only female subjects will be included in this research
- Is scheduled to receive <3 months or >6 months of chemotherapy
- Has received 2+ cycles of chemotherapy at enrollment
- Stage 0 breast cancer diagnosis or metastatic disease
- Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
- Is not cleared to participate in exercise by a physician.
Show all 13Show fewer
- Unwilling to complete baseline behavioral, neurocognitive, and patient-reported assessments (accelerometry, cognitive tasks, questionnaires)
- Unwilling to be randomized
- Unwilling to continuously wear and regularly sync/charge the Fitbit device during the study period.
- Unable to read and speak in English
- Unwilling to provide written informed consent to participate
- Cognitive impairment (score <21 on the TICS-M) prior to baseline assessment
- History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Aim 1: This pilot study tests the feasibility and acceptability of a mobile app-based behavioral intervention in 40 women receiving chemotherapy for breast cancer. Participants will be randomized to receive app components following a 2x2 factorial design. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at post-intervention (1 month post-chemotherapy).
Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects; Move+Exercise) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing.
Exploratory Aim: Explore the effects of the intervention components on correlates of cancer-associated cognitive decline. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes, specifically cancer-related fatigue. Participants will also completed brief ecological momentary assessments (EMAs) their mobile phones across four 14-day measurement bursts at pre-intervention, mid-chemotherapy, and 1 month post-chemotherapy to further explore associations among behavioral patterns, cognition, and correlates.
Read the detailed description
Cancer-related cognitive impairment (CRCI) is a research priority due to its rising prevalence and dramatic impacts on survivors' quality of life and health long-term. Strong evidence supports the efficacy of physical activity (PA) for improving cognitive function and key CRCI correlates. The aim of the proposed study is to pilot test an innovative, mHealth intervention designed to ameliorate CRCI in women receiving chemotherapy for breast cancer. This study will employ an efficient 2x2 factorial design to compare PA prescriptions targeting frequent PA of any intensity and reduced daily sitting (Move); aerobic exercise (consistent with PA guidelines for cancer survivors; Exercise); both (Move+Exercise); or none (Core). The main and interactive effects of these intervention components on CRCI and its underlying mechanisms will be tested across the breast cancer trajectory. Aim 1: This pilot study aims to test the feasibility and acceptability of the mHealth intervention in 40 women receiving chemotherapy for breast cancer. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at a baseline orientation and at post-intervention (1 month post-chemotherapy). Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing. Exploratory Aim: Explore the effects of the intervention components on CRCI correlates. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes (e.g., fatigue, depressive symptoms). Participants will also complete brief ecological momentary assessments (EMAs) on their mobile phones across four 14-day measurement bursts to further explore associations among behavioral patterns, cognition, and CRCI correlates. To test the specific aims, women diagnosed with breast cancer and scheduled to receive 3-6 months of chemotherapy (N=40) will be randomized to receive select mHealth intervention components, including Core (attentional control), Move, Exercise, or Move+Exercise (n=10 each condition). Data will be analyzed using descriptive statistics and axial coding (Aim 1); analysis of covariance and standard mean difference (Aim 2 and Exploratory); and hierarchical linear modeling (Exploratory). Findings will provide the necessary pilot data to support a grant application for a fully-powered trial.
- Conditions
- Breast Neoplasms, Breast Cancer Female
- Being tested
- Physical Activity, Attentional Control
- Keywords
- breast cancer, physical activity, cognition, chemotherapy
- 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.
Physical ActivityBehavioural
Mobile app intervention delivered during chemotherapy for breast cancer that combines goal setting, behavioral monitoring, and goal achievement badges with telecoaching to achieve physical activity prescriptions.
Attentional ControlBehavioural
Mobile app intervention delivered during chemotherapy for breast cancer that includes telecoaching on general and cancer-related health topics and basic physical activity monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Core Component (tele-coaching, emails, smartphone app & Fitbit) | Active comparator | All participants will receive the Core component, which includes access to weekly tele-coaching, weekly emails from the interventionist, a smartphone app, and a Fitbit monitor. Tele-coaching will include discussion of general cancer-related and wellness topics, and the smartphone app will have basic activity monitoring features. Receives: Behavioral: Attentional Control |
| Move (tele-coaching calls, smartphone app & Move goals & badges) | Experimental | Tele-coaching calls for Move participants will be based in social cognitive theory to encourage behavior adoption and goal setting focused on reducing prolonged sitting. Smartphone app features include activity monitoring that visualizes progress toward Move-based goals and goal achievement badges specific to Move. Receives: Behavioral: Physical Activity |
| Exercise (tele-coaching calls & smartphone app) | Experimental | Tele-coaching calls for Exercise participants will be based in social cognitive theory to encourage behavior adoption and goal setting focused on engaging in 30 minutes of moderate-intensity physical activity per day (in 10+ minute bouts). Smartphone app features include activity monitoring that visualizes progress toward Exercise-based goals and goal achievement badges specific to Exercise. Receives: Behavioral: Physical Activity |
| Combo (Move+Exercise) | Experimental | Includes tele-coaching that encourages behavior adoption and goal setting focused on reducing prolonged sitting and engaging in 30+ minutes of physical activity per day. Participants are able to visualize progress toward Move and Exercise goals and are eligible to receive achievement badges for Move and Exercise. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
intervention attendance
completion of telecoaching sessions
Measured: 1 month post-chemotherapy
Participant satisfaction: survey
usability survey
Measured: 1 month post-chemotherapy
recruitment yield
number of women who enroll compared to the number of contacts of eligible women required to obtain target sample size
Measured: Baseline
retention
proportion of participants providing post-intervention data
Measured: 1 month post-chemotherapy
acceptability of intervention: in-depth interview
in-depth interview to gather participant perceptions on the acceptability and usefulness of the mobile app features
Measured: 1 month post-chemotherapy
Secondary outcomes (7)
Change in Stroop task performance
Interference score on Stroop task
Measured: Baseline, 1 month post-chemotherapy
Change in Task-Switch task performance
Reaction time on Task-Switch
Measured: Baseline, 1 month post-chemotherapy
Change in Trails task performance
Completion time of Trails
Measured: Baseline, 1 month post-chemotherapy
Change in N-Back task performance
Correct responses on N-back
Measured: Baseline, 1 month post-chemotherapy
Change in Spatial Working Memory task performance
Correct responses on Spatial Working Memory task
Measured: Baseline, 1 month post-chemotherapy
Change in Auditory Verbal Learning Task (AVLT) performance
Total numbered recalled on AVLT
Measured: Baseline, 1 month post-chemotherapy
Change in objective physical activity behavior
Objective activity behavior (average minutes of physical activity per day) will be measured using actigraphy.
Measured: Baseline, 1 month post-chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start15 Jan 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Laura D Bilek, PT, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562987
- Sponsor's protocol ID
- 0736-19-FB
- Other IDs
- 1U54GM115458
- Acronym
- PACT
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available to other researchers upon request and approval by the PI.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patterns of Activity and Cognition During Treatment (PACT) Study
- ClinicalTrials.gov ID
- NCT04562987
- Acronym / sponsor ID
- PACT / 0736-19-FB
- Conditions
- Breast Neoplasms, Breast Cancer Female
- Keywords
- breast cancer, physical activity, cognition, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Wake Forest University
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 24 Sep 2020 (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.
Aim 1: This pilot study tests the feasibility and acceptability of a mobile app-based behavioral intervention in 40 women receiving chemotherapy for breast cancer. Participants will be randomized to receive app components following a 2x2 factorial design. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at post-intervention (1 month post-chemotherapy).
Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects; Move+Exercise) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing.
Exploratory Aim: Explore the effects of the intervention components on correlates of cancer-associated cognitive decline. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes, specifically cancer-related fatigue. Participants will also completed brief ecological momentary assessments (EMAs) their mobile phones across four 14-day measurement bursts at pre-intervention, mid-chemotherapy, and 1 month post-chemotherapy to further explore associations among behavioral patterns, cognition, and correlates.
Detailed description
Cancer-related cognitive impairment (CRCI) is a research priority due to its rising prevalence and dramatic impacts on survivors' quality of life and health long-term. Strong evidence supports the efficacy of physical activity (PA) for improving cognitive function and key CRCI correlates. The aim of the proposed study is to pilot test an innovative, mHealth intervention designed to ameliorate CRCI in women receiving chemotherapy for breast cancer. This study will employ an efficient 2x2 factorial design to compare PA prescriptions targeting frequent PA of any intensity and reduced daily sitting (Move); aerobic exercise (consistent with PA guidelines for cancer survivors; Exercise); both (Move+Exercise); or none (Core). The main and interactive effects of these intervention components on CRCI and its underlying mechanisms will be tested across the breast cancer trajectory. Aim 1: This pilot study aims to test the feasibility and acceptability of the mHealth intervention in 40 women receiving chemotherapy for breast cancer. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at a baseline orientation and at post-intervention (1 month post-chemotherapy). Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing. Exploratory Aim: Explore the effects of the intervention components on CRCI correlates. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes (e.g., fatigue, depressive symptoms). Participants will also complete brief ecological momentary assessments (EMAs) on their mobile phones across four 14-day measurement bursts to further explore associations among behavioral patterns, cognition, and CRCI correlates. To test the specific aims, women diagnosed with breast cancer and scheduled to receive 3-6 months of chemotherapy (N=40) will be randomized to receive select mHealth intervention components, including Core (attentional control), Move, Exercise, or Move+Exercise (n=10 each condition). Data will be analyzed using descriptive statistics and axial coding (Aim 1); analysis of covariance and standard mean difference (Aim 2 and Exploratory); and hierarchical linear modeling (Exploratory). Findings will provide the necessary pilot data to support a grant application for a fully-powered trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Core Component (tele-coaching, emails, smartphone app & Fitbit) | Active comparator | Behavioral: Attentional ControlAll participants will receive the Core component, which includes access to weekly tele-coaching, weekly emails from the interventionist, a smartphone app, and a Fitbit monitor. Tele-coaching will include discussion of general cancer-related and wellness topics, and the smartphone app will have basic activity monitoring features. |
| Move (tele-coaching calls, smartphone app & Move goals & badges) | Experimental | Behavioral: Physical ActivityTele-coaching calls for Move participants will be based in social cognitive theory to encourage behavior adoption and goal setting focused on reducing prolonged sitting. Smartphone app features include activity monitoring that visualizes progress toward Move-based goals and goal achievement badges specific to Move. |
| Exercise (tele-coaching calls & smartphone app) | Experimental | Behavioral: Physical ActivityTele-coaching calls for Exercise participants will be based in social cognitive theory to encourage behavior adoption and goal setting focused on engaging in 30 minutes of moderate-intensity physical activity per day (in 10+ minute bouts). Smartphone app features include activity monitoring that visualizes progress toward Exercise-based goals and goal achievement badges specific to Exercise. |
| Combo (Move+Exercise) | Experimental | Behavioral: Physical ActivityIncludes tele-coaching that encourages behavior adoption and goal setting focused on reducing prolonged sitting and engaging in 30+ minutes of physical activity per day. Participants are able to visualize progress toward Move and Exercise goals and are eligible to receive achievement badges for Move and Exercise. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female
- Aged 21 years or older
- First, primary diagnosis of Stage I-III breast cancer
- Scheduled to receive chemotherapy for 3-6 months. While evidence suggests declines in cognition and brain health due to cancer may be evident both in women who receive and who do not receive chemotherapy, those receiving chemotherapy consistently experience the greatest changes.
- Has received no more than one cycle of chemotherapy
Key exclusion criteria (13 listed)
- Males. Breast cancer is often classified specifically as female breast cancer, as 99% of cases occur in women. Our small sample size does not statistically justify the inclusion of males in this study. As such, only female subjects will be included in this research
- Is scheduled to receive <3 months or >6 months of chemotherapy
- Has received 2+ cycles of chemotherapy at enrollment
- Stage 0 breast cancer diagnosis or metastatic disease
- Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
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 |
|---|---|---|
| Physical ActivityMobile app intervention delivered during chemotherapy for breast cancer that combines goal setting, behavioral monitoring, and goal achievement badges with telecoaching to achieve physical activity prescriptions. | Behavioural | Combo (Move+Exercise), Exercise (tele-coaching calls & smartphone app), Move (tele-coaching calls, smartphone app & Move goals & badges) |
| Attentional ControlMobile app intervention delivered during chemotherapy for breast cancer that includes telecoaching on general and cancer-related health topics and basic physical activity monitoring. | Behavioural | Core Component (tele-coaching, emails, smartphone app & Fitbit) |
Primary outcome
intervention attendance
Time frame: 1 month post-chemotherapy
completion of telecoaching sessions
Participant satisfaction: survey
Time frame: 1 month post-chemotherapy
usability survey
recruitment yield
Time frame: Baseline
number of women who enroll compared to the number of contacts of eligible women required to obtain target sample size
retention
Time frame: 1 month post-chemotherapy
proportion of participants providing post-intervention data
acceptability of intervention: in-depth interview
Time frame: 1 month post-chemotherapy
in-depth interview to gather participant perceptions on the acceptability and usefulness of the mobile app features
7 secondary outcomes
Change in Stroop task performance
Time frame: Baseline, 1 month post-chemotherapy
Change in Task-Switch task performance
Time frame: Baseline, 1 month post-chemotherapy
Change in Trails task performance
Time frame: Baseline, 1 month post-chemotherapy
Change in N-Back task performance
Time frame: Baseline, 1 month post-chemotherapy
Change in Spatial Working Memory task performance
Time frame: Baseline, 1 month post-chemotherapy
Change in Auditory Verbal Learning Task (AVLT) performance
Time frame: Baseline, 1 month post-chemotherapy
Change in objective physical activity behavior
Time frame: Baseline, 1 month post-chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available to other researchers upon request and approval by the PI.
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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.
Laura D Bilek, PT, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Breast Neoplasms and Breast Cancer Female, run by University of Nebraska 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 15 inclusion and 13 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 28 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intervention attendance (time frame: 1 month post-chemotherapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.