Clinical trial NCT04129346: Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
Official title: Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Obesity
Keywords: Inactivity
Breast Cancer
Metastatic Breast Cancer
Quality of life
Sedentary
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-16
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.

Detailed description: The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT). We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. Inactive MBC patients will be assigned to Fit2ThriveMB or education control. Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Participants in the education control will be asked to download the app cancer.net from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.

Eligibility criteria: Inclusion Criteria:

* Female; ≥18 years of age
* Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
* Fluent in spoken and written English
* Own a smartphone
* Have access to the internet to complete assessments
* Self-report engaging in \<150 minutes of moderate to vigorous PA per week.

Exclusion Criteria:

* Untreated brain metastases
* Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
* Current enrollment in another dietary or PA trial

Primary outcomes:
measure: Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period
timeFrame: 12 weeks
measure: Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients
timeFrame: 12 weeks
measure: Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients
timeFrame: Baseline and 12 weeks
measure: Change in Quality of Life From From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Anxiety From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Depression From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Fatigue From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Pain Interference From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Physical Function From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Sleep Disturbance From Baseline to 12-weeks
timeFrame: Baseline and 12 weeks
measure: Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.
timeFrame: Baseline and 12 weeks
measure: Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: Phillips S, Solk P, Welch W, Auster-Gussman L, Lu M, Cullather E, Torre E, Whitaker M, Izenman E, La J, Lee J, Spring B, Gradishar W. A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 23;10(4):e24254. doi: 10.2196/24254.