Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03131440
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 280
• Location: 1
• Arms: 32
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 10.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female; Physical Activity	Behavioral: Core; Behavioral: Support Calls; Behavioral: App+; Behavioral: Online gym; Behavioral: App notifications; Behavioral: Buddy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
• Actual Study Start Date: Apr 24, 2017
• Actual Primary Completion Date: Jun 17, 2019
• Actual Study Completion Date: Jun 17, 2019

Arms and Interventions

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: Online gym; Participants will receive access to online exercise videos.; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.
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: Online gym; Participants will receive access to online exercise videos.; Behavioral: App notifications; Participants will receive motivational app notifications; Behavioral: Buddy; Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Outcome Measures

Primary Outcome Measures

1. Participant Adherence [12 weeks]

   Proportion of weeks meeting physical activity goal

2. Participant retention [12 weeks]

   Proportion of participants retained of those randomzied

3. Intervention Reach [Baseline]

   Proportion of individuals who agree to participate of those who express an interest in participation

Secondary Outcome Measures

1. Physical Activity as Measured by Actigraph Accelerometer [Change from baseline to 12 weeks]

2. Physical Activity as Measured by Actigraph Accelerometer [Change from baseline to 24 weeks]

3. PROMIS Fatigue Short Form 8a [Change from baseline to 12 weeks]

4. PROMIS Fatigue Short Form 8a [Change from baseline to 24 weeks]

5. PROMIS Physical Function Short Form 20a [Change from baseline to 12 weeks]

6. PROMIS Physical Function Short Form 20a [Change from baseline to 24 weeks]

7. PROMIS Depression Short Form 8a [Change from baseline to 12 weeks]

8. PROMIS Depression Short Form 8a [Change from baseline to 24 weeks]

9. Participant Adherence [24 weeks]

   Proportion of weeks meeting physical activity goal

10. Participant retention [24 weeks]

    Proportion of participants retained of those randomzied

11. Inflammation (Optional) [Change from baseline to 12 weeks]

    Interleukin-6 (IL-6), tumor necrosis factor-alpha (TNFα), Interleukin-10 (IL-10) and C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot. IL-6, IL-10 and TNFα will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. CRP will be quantified using standard ELISA.

12. Inflammation (Optional) [Change from baseline to 24 weeks]

    Interleukin-6 (IL-6), tumor necrosis factor-alpha (TNFα), Interleukin-10 (IL-10) and C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot. IL-6, IL-10 and TNFα will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. CRP will be quantified using standard ELISA.

13. Cardiometabolic Disease Risk (optional) [Change from baseline to 12 weeks]

    Blood glucose, trigylcerides, total cholesterol and high density lipoprotein cholesteroal will be self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.

14. Cardiometabolic Disease Risk (optional) [Change from baseline to 24 weeks]

    Blood glucose, trigylcerides, total cholesterol and high density lipoprotein cholesteroal will be self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• National Cancer Institute (NCI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Siobhan M Phillips, Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT03131440
• Other Study ID Numbers: K07CA196840; K07CA196840; R21CA219028-01A1
• First Posted: Apr 27, 2017
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 4, 2020