Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Breast Cancer Female
• Intervention / Treatment: Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Buddy; Behavioral: Online gym; Behavioral: App notifications

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

32

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): June 17, 2019
• Study Completion (Actual): June 17, 2019

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: K07CA196840 (U.S. NIH Grant/Contract); R21CA219028-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No