N/A
N=49
Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
Metastatic Breast Cancer · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04129346 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period — 24; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fit2ThriveMB App (Behavioral); Fitbit (Behavioral); Physical Activity Coaching Calls (Behavioral); Healthy Living Coaching Calls (Behavioral); Cancer.net app (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period |
24; 24 | — |
| PRIMARY Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients |
98.2 | — |
| PRIMARY Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients |
24 | — |
| SECONDARY Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients |
-3.5; -18.7 | — |
| SECONDARY Change in Quality of Life From From Baseline to 12-weeks |
1.7; 2.0 | — |
| SECONDARY Change in Anxiety From Baseline to 12-weeks |
0.8; 1.1 | — |
| SECONDARY Change in Depression From Baseline to 12-weeks |
0.1; -0.05 | — |
| SECONDARY Change in Fatigue From Baseline to 12-weeks |
-2.7; 0.6 | — |
| SECONDARY Change in Pain Interference From Baseline to 12-weeks |
3.2; -1.5 | — |
| SECONDARY Change in Physical Function From Baseline to 12-weeks |
-0.1; 1.4 | — |
| SECONDARY Change in Sleep Disturbance From Baseline to 12-weeks |
-0.3; -0.2 | — |
| SECONDARY Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks |
.41; -.55 | — |
| SECONDARY Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks |
1.42; 2.91; 12.92; 3.70 | — |
| SECONDARY Change in 6-minute Walk Test Distance Between Baseline and 12-weeks. |
19.42; 15.10 | — |
| SECONDARY Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks |
1.48; -1.33; 4.40; 1.87; -0.23; 0.29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04129346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.