Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Physical Activity; Breast Cancer Female
• Interventions: Behavioral: Core; Behavioral: App notifications; Behavioral: Support Calls; Behavioral: Online gym; Behavioral: App+; Behavioral: Buddy

• Registration Number: NCT03131440
• Lead Sponsor: Northwestern University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-18
• Study Start: 2017-04-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2019-06-17
• Study Completion: 2019-06-17
• Results First Submitted: 2022-12-14
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Results First Posted: 2023-03-10
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

1. Diagnosed with Stage I-III breast cancer within the last 5 years
2. Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
3. English speaking
4. Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
5. Own a smartphone
6. Have access to a computer with Internet
7. Participants may be using adjuvant endocrine therapies.
8. Willing to be waitlisted for future wave if current wave reaches capacity

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Exclusion Criteria

-Women will be excluded if they report any of the following:

1. Respiratory, joint or cardiovascular problems precluding physical activity
2. Metastatic disease
3. 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:

1. A prior cardiovascular event (i.e. stroke, myocardial infarction)
2. 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental Condition #15	App notifications	core, app notifications
Experimental Condition #19	Support Calls	core, support calls, buddy, online gym
Experimental Condition #11	Core	core, buddy, online gym
Experimental Condition #13	Core	core, online gym
Experimental Condition #12	Buddy	core, buddy, app notifications
Experimental Condition #14	Online gym	core, online gym, app notifications
Experimental Condition #14	Core	core, online gym, app notifications
Experimental Condition #4	Support Calls	core, support calls, online gym
Experimental Condition #15	Core	core, app notifications
Experimental Condition #23	App+	core, app+, buddy, online gym, app notifications
Experimental Condition #2	App+	core, support calls, app+
Experimental Condition #3	Support Calls	core, support calls, buddy
Experimental Condition #1	Core	core, support calls
Experimental Condition #3	Buddy	core, support calls, buddy
Experimental Condition #4	Core	core, support calls, online gym
Experimental Condition #3	Core	core, support calls, buddy
Experimental Condition #9	App notifications	core, app+, app notifications
Experimental Condition #1	Support Calls	core, support calls
Experimental Condition #4	Online gym	core, support calls, online gym
Experimental Condition #18	App notifications	core, support calls, app+, app notifications
Experimental Condition #10	Core	core, buddy
Experimental Condition #2	Core	core, support calls, app+
Experimental Condition #14	App notifications	core, online gym, app notifications
Experimental Condition #17	Support Calls	core, support calls, app+, online gym
Experimental Condition #20	Support Calls	core, support calls, buddy, app notifications
Experimental Condition #22	App+	core, app+, buddy, online gym
Experimental Condition #22	Online gym	core, app+, buddy, online gym
Experimental Condition #2	Support Calls	core, support calls, app+
Experimental Condition #5	Core	core, support calls, app notifications
Experimental Condition #6	App+	core, app+
Experimental Condition #8	Core	core, app+, online gym
Experimental Condition #8	Online gym	core, app+, online gym
Experimental Condition #9	App+	core, app+, app notifications
Experimental Condition #11	Online gym	core, buddy, online gym
Experimental Condition #11	Buddy	core, buddy, online gym
Experimental Condition #12	App notifications	core, buddy, app notifications
Experimental Condition #13	Online gym	core, online gym
Experimental Condition #5	Support Calls	core, support calls, app notifications
Experimental Condition #5	App notifications	core, support calls, app notifications
Experimental Condition #6	Core	core, app+
Experimental Condition #7	App+	core, app+, buddy
Experimental Condition #7	Buddy	core, app+, buddy
Experimental Condition #9	Core	core, app+, app notifications
Experimental Condition #12	Core	core, buddy, app notifications
Experimental Condition #16	Core	core, support calls, app+, buddy
Experimental Condition #10	Buddy	core, buddy
Experimental Condition #7	Core	core, app+, buddy
Experimental Condition #8	App+	core, app+, online gym
Experimental Condition #16	Support Calls	core, support calls, app+, buddy
Experimental Condition #17	App+	core, support calls, app+, online gym
Experimental Condition #22	Core	core, app+, buddy, online gym
Experimental Condition #23	App notifications	core, app+, buddy, online gym, app notifications
Experimental Condition #16	App+	core, support calls, app+, buddy
Experimental Condition #16	Buddy	core, support calls, app+, buddy
Experimental Condition #17	Core	core, support calls, app+, online gym
Experimental Condition #17	Online gym	core, support calls, app+, online gym
Experimental Condition #18	Support Calls	core, support calls, app+, app notifications
Experimental Condition #18	App+	core, support calls, app+, app notifications
Experimental Condition #19	Online gym	core, support calls, buddy, online gym
Experimental Condition #19	Buddy	core, support calls, buddy, online gym
Experimental Condition #24	Core	core, support calls, buddy, online gym, app notifications
Experimental Condition #24	Support Calls	core, support calls, buddy, online gym, app notifications
Experimental Condition #18	Core	core, support calls, app+, app notifications
Experimental Condition #19	Core	core, support calls, buddy, online gym
Experimental Condition #20	Buddy	core, support calls, buddy, app notifications
Experimental Condition #21	Support Calls	core, support calls, online gym, app notifications
Experimental Condition #23	Core	core, app+, buddy, online gym, app notifications
Experimental Condition #26	App+	core, app+, online gym, app notifications
Experimental Condition #20	Core	core, support calls, buddy, app notifications
Experimental Condition #20	App notifications	core, support calls, buddy, app notifications
Experimental Condition #23	Buddy	core, app+, buddy, online gym, app notifications
Experimental Condition #27	Support Calls	core, support calls, app+, buddy, online gym
Experimental Condition #28	Support Calls	core, support calls, app+, buddy, app notifications
Experimental Condition #29	Core	core, support calls, app+, online gym, app notifications
Experimental Condition #29	Support Calls	core, support calls, app+, online gym, app notifications
Experimental Condition #30	Core	core
Experimental Condition #32	Core	core, support calls, app+, buddy, online gym, app notifications
Experimental Condition #21	Core	core, support calls, online gym, app notifications
Experimental Condition #21	Online gym	core, support calls, online gym, app notifications
Experimental Condition #21	App notifications	core, support calls, online gym, app notifications
Experimental Condition #22	Buddy	core, app+, buddy, online gym
Experimental Condition #23	Online gym	core, app+, buddy, online gym, app notifications
Experimental Condition #31	Core	core, app+, buddy, app notifications
Experimental Condition #24	Online gym	core, support calls, buddy, online gym, app notifications
Experimental Condition #24	App notifications	core, support calls, buddy, online gym, app notifications
Experimental Condition #25	App notifications	core, buddy, online gym, app notifications
Experimental Condition #25	Buddy	core, buddy, online gym, app notifications
Experimental Condition #26	Online gym	core, app+, online gym, app notifications
Experimental Condition #27	Core	core, support calls, app+, buddy, online gym
Experimental Condition #29	App+	core, support calls, app+, online gym, app notifications
Experimental Condition #29	App notifications	core, support calls, app+, online gym, app notifications
Experimental Condition #31	App notifications	core, app+, buddy, app notifications
Experimental Condition #24	Buddy	core, support calls, buddy, online gym, app notifications
Experimental Condition #25	Core	core, buddy, online gym, app notifications
Experimental Condition #25	Online gym	core, buddy, online gym, app notifications
Experimental Condition #26	Core	core, app+, online gym, app notifications
Experimental Condition #26	App notifications	core, app+, online gym, app notifications
Experimental Condition #27	Online gym	core, support calls, app+, buddy, online gym
Experimental Condition #27	Buddy	core, support calls, app+, buddy, online gym
Experimental Condition #28	Core	core, support calls, app+, buddy, app notifications
Experimental Condition #28	App+	core, support calls, app+, buddy, app notifications
Experimental Condition #28	App notifications	core, support calls, app+, buddy, app notifications
Experimental Condition #28	Buddy	core, support calls, app+, buddy, app notifications
Experimental Condition #29	Online gym	core, support calls, app+, online gym, app notifications
Experimental Condition #27	App+	core, support calls, app+, buddy, online gym
Experimental Condition #31	App+	core, app+, buddy, app notifications
Experimental Condition #31	Buddy	core, app+, buddy, app notifications
Experimental Condition #32	Support Calls	core, support calls, app+, buddy, online gym, app notifications
Experimental Condition #32	App+	core, support calls, app+, buddy, online gym, app notifications
Experimental Condition #32	Online gym	core, support calls, app+, buddy, online gym, app notifications
Experimental Condition #32	Buddy	core, support calls, app+, buddy, online gym, app notifications
Experimental Condition #32	App notifications	core, support calls, app+, buddy, online gym, app notifications

Primary Outcome Measures

Name	Time	Method
Adherence to a 12 Week Technology Supported Physical Activity Intervention	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	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	Baseline	Percentage of individuals randomized of those who were sent a study screening survey

Secondary Outcome Measures

Name	Time	Method
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention	Change from baseline to 12 weeks	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 in Fatigue From Before to After a 12-Week Intervention	Change from baseline to 12 weeks	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 in Fatigue From Pre-Intervention to 24-Week Follow-up	Change from baseline to 24 weeks	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 in Depression From Pre-Intervention to 24-week Follow-up	Change from baseline to 24 weeks	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 in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)	Change from baseline to 12 weeks	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 in Blood Glucose From Before to After a 12 Week Intervention (Optional)	Change from baseline to 12 weeks	Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)	Change from baseline to 24 weeks	Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)	Change from baseline to 12 weeks	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 in Depression From Before to After a 12-Week Intervention	Change from baseline to 12 weeks	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.
Adherence to During the Full 24-Week Study Period	24 weeks	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.
Participant Retention at 24 Week Follow-up	24 weeks	Percentage of participants retained at 24 weeks of those randomized
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)	Change from baseline to 12 weeks	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 in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)	Change from baseline to 12 weeks	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 in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)	Change from baseline to 24 weeks	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 in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)	Change from baseline to 24 weeks	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 in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up	Change from baseline to 24 weeks	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).
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up	Change from baseline to 24 weeks	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 in Triglycerides From Before to After a 12 Week Intervention (Optional)	Change from baseline to 12 weeks	Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)	Change from baseline to 24 weeks	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 in Physical Function From Before to After a 12-Week Intervention	Change from baseline to 12 weeks	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 in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)	Change from baseline to 24 weeks	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 in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)	Change from baseline to 24 weeks	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 in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)	Change from baseline to 24 weeks	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 in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)	Change from baseline to 12 weeks	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States