Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors

Conditions
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Breast Cancer Female, Physical Activity

Intervention / Treatment
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* Behavioral: Core
* Behavioral: Support Calls
* Behavioral: App+
* Behavioral: Online gym
* Behavioral: App notifications
* Behavioral: Buddy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Condition #1<br>core, support calls | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>|
| Experimental: Experimental Condition #2<br>core, support calls, app+ | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>|
| Experimental: Experimental Condition #3<br>core, support calls, buddy | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #4<br>core, support calls, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>|
| Experimental: Experimental Condition #5<br>core, support calls, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #6<br>core, app+ | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>|
| Experimental: Experimental Condition #7<br>core, app+, buddy | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #8<br>core, app+, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>|
| Experimental: Experimental Condition #9<br>core, app+, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #10<br>core, buddy | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #11<br>core, buddy, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #12<br>core, buddy, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #13<br>core, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>|
| Experimental: Experimental Condition #14<br>core, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #15<br>core, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #16<br>core, support calls, app+, buddy | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #17<br>core, support calls, app+, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>|
| Experimental: Experimental Condition #18<br>core, support calls, app+, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #19<br>core, support calls, buddy, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #20<br>core, support calls, buddy, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #21<br>core, support calls, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #22<br>core, app+, buddy, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #23<br>core, app+, buddy, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #24<br>core, support calls, buddy, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #25<br>core, buddy, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #26<br>core, app+, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #27<br>core, support calls, app+, buddy, online gym | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #28<br>core, support calls, app+, buddy, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #29<br>core, support calls, app+, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>|
| Experimental: Experimental Condition #30<br>core | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>|
| Experimental: Experimental Condition #31<br>core, app+, buddy, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|
| Experimental: Experimental Condition #32<br>core, support calls, app+, buddy, online gym, app notifications | Behavioral: Core<br>* The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.<br>Behavioral: Support Calls<br>* Participants will receive 6 bi-weekly phone calls from study staff.<br>Behavioral: App+<br>* Participants will receive deluxe version of smartphone app with additional features.<br>Behavioral: Online gym<br>* Participants will receive access to online exercise videos.<br>Behavioral: App notifications<br>* Participants will receive motivational app notifications<br>Behavioral: Buddy<br>* Participants will choose a buddy to receive a Fitbit and support them during the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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]. | 12 weeks | 
| Intervention Reach | Percentage of individuals randomized of those who were sent a study screening survey | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 weeks | 
| Participant Retention at 24 Week Follow-up | Percentage of participants retained at 24 weeks of those randomized | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from baseline to 24 weeks |