Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
NCT ID: NCT03131440
Last Updated: 2023-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2017-04-24
2019-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental Condition #1
core, support calls
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
Experimental Condition #2
core, support calls, app+
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Experimental Condition #3
core, support calls, buddy
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #4
core, support calls, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
Online gym
Participants will receive access to online exercise videos.
Experimental Condition #5
core, support calls, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App notifications
Participants will receive motivational app notifications
Experimental Condition #6
core, app+
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Experimental Condition #7
core, app+, buddy
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #8
core, app+, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
Experimental Condition #9
core, app+, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
App notifications
Participants will receive motivational app notifications
Experimental Condition #10
core, buddy
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #11
core, buddy, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym
Participants will receive access to online exercise videos.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #12
core, buddy, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #13
core, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym
Participants will receive access to online exercise videos.
Experimental Condition #14
core, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Experimental Condition #15
core, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications
Participants will receive motivational app notifications
Experimental Condition #16
core, support calls, app+, buddy
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #17
core, support calls, app+, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
Experimental Condition #18
core, support calls, app+, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
App notifications
Participants will receive motivational app notifications
Experimental Condition #19
core, support calls, buddy, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
Online gym
Participants will receive access to online exercise videos.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #20
core, support calls, buddy, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #21
core, support calls, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Experimental Condition #22
core, app+, buddy, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #23
core, app+, buddy, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #24
core, support calls, buddy, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #25
core, buddy, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #26
core, app+, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Experimental Condition #27
core, support calls, app+, buddy, online gym
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #28
core, support calls, app+, buddy, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #29
core, support calls, app+, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Experimental Condition #30
core
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Experimental Condition #31
core, app+, buddy, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Experimental Condition #32
core, support calls, app+, buddy, online gym, app notifications
Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Interventions
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Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
App+
Participants will receive "deluxe" version of smartphone app with additional features.
Online gym
Participants will receive access to online exercise videos.
App notifications
Participants will receive motivational app notifications
Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Siobhan M Phillips
Assistant Professor
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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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.
Solk 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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