Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB

Northwestern University

Status: Completed

Conditions: Obesity; Metastatic Breast Cancer

Treatments: Behavioral: Fit2ThriveMB App; Behavioral: Healthy Living Coaching Calls; Behavioral: Fitbit; Behavioral: Cancer.net app; Behavioral: Physical Activity Coaching Calls

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04129346

R21CA239130 (U.S. NIH Grant/Contract)

SP00049673

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Fit2ThriveMB

Experimental group

Description:

Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.

Treatment:

Behavioral: Fit2ThriveMB App

Behavioral: Physical Activity Coaching Calls

Behavioral: Fitbit

Healthy Living Control

Active Comparator group

Description:

Participants in the healthy living group will receive the American Society of Cancer Oncologists smartphone app, cancer.net. They will also receive calls during the intervention period and the Fitbit following completion of 12 week assessments

Treatment:

Behavioral: Cancer.net app

Behavioral: Healthy Living Coaching Calls