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
2 other identifiers
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2017
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2019
CompletedResults Posted
Study results publicly available
March 10, 2023
CompletedMarch 10, 2023
February 1, 2023
2.1 years
April 18, 2017
December 14, 2022
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (24)
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Change from baseline to 12 weeks
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Change from baseline to 24 weeks
Change in Fatigue From Before to After a 12-Week Intervention
Change from baseline to 12 weeks
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Change from baseline to 24 weeks
Change in Physical Function From Before to After a 12-Week Intervention
Change from baseline to 12 weeks
- +19 more secondary outcomes
Study Arms (32)
Experimental Condition #1
EXPERIMENTALcore, support calls
Experimental Condition #2
EXPERIMENTALcore, support calls, app+
Experimental Condition #3
EXPERIMENTALcore, support calls, buddy
Experimental Condition #4
EXPERIMENTALcore, support calls, online gym
Experimental Condition #5
EXPERIMENTALcore, support calls, app notifications
Experimental Condition #6
EXPERIMENTALcore, app+
Experimental Condition #7
EXPERIMENTALcore, app+, buddy
Experimental Condition #8
EXPERIMENTALcore, app+, online gym
Experimental Condition #9
EXPERIMENTALcore, app+, app notifications
Experimental Condition #10
EXPERIMENTALcore, buddy
Experimental Condition #11
EXPERIMENTALcore, buddy, online gym
Experimental Condition #12
EXPERIMENTALcore, buddy, app notifications
Experimental Condition #13
EXPERIMENTALcore, online gym
Experimental Condition #14
EXPERIMENTALcore, online gym, app notifications
Experimental Condition #15
EXPERIMENTALcore, app notifications
Experimental Condition #16
EXPERIMENTALcore, support calls, app+, buddy
Experimental Condition #17
EXPERIMENTALcore, support calls, app+, online gym
Experimental Condition #18
EXPERIMENTALcore, support calls, app+, app notifications
Experimental Condition #19
EXPERIMENTALcore, support calls, buddy, online gym
Experimental Condition #20
EXPERIMENTALcore, support calls, buddy, app notifications
Experimental Condition #21
EXPERIMENTALcore, support calls, online gym, app notifications
Experimental Condition #22
EXPERIMENTALcore, app+, buddy, online gym
Experimental Condition #23
EXPERIMENTALcore, app+, buddy, online gym, app notifications
Experimental Condition #24
EXPERIMENTALcore, support calls, buddy, online gym, app notifications
Experimental Condition #25
EXPERIMENTALcore, buddy, online gym, app notifications
Experimental Condition #26
EXPERIMENTALcore, app+, online gym, app notifications
Experimental Condition #27
EXPERIMENTALcore, support calls, app+, buddy, online gym
Experimental Condition #28
EXPERIMENTALcore, support calls, app+, buddy, app notifications
Experimental Condition #29
EXPERIMENTALcore, support calls, app+, online gym, app notifications
Experimental Condition #30
EXPERIMENTALcore
Experimental Condition #31
EXPERIMENTALcore, app+, buddy, app notifications
Experimental Condition #32
EXPERIMENTALcore, support calls, app+, buddy, online gym, app notifications
Interventions
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (2)
Solk P, Song J, Reading J, Starikovsky J, Cullather E, Wang S, Hasanaj K, Morelli WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Frey J, Phillips SM. Feasibility and acceptability of the Fit2Thrive mHealth physical activity promotion intervention components in breast cancer survivors. Transl Behav Med. 2025 Jan 16;15(1):ibaf033. doi: 10.1093/tbm/ibaf033.
PMID: 40795071DERIVEDSolk P, Song J, Welch WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Freeman H, Starikovsky J, Mishory A, Alexander J, Wolter M, Carden L, Phillips SM. Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial. Ann Behav Med. 2023 Aug 21;57(9):765-776. doi: 10.1093/abm/kaad024.
PMID: 37203237DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Siobhan Phillips
- Organization
- Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 18, 2017
First Posted
April 27, 2017
Study Start
April 24, 2017
Primary Completion
June 17, 2019
Study Completion
June 17, 2019
Last Updated
March 10, 2023
Results First Posted
March 10, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.