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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129346
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : June 10, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Siobhan M Phillips, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Obesity Behavioral: Fit2ThriveMB App Behavioral: Fitbit Behavioral: Physical Activity Coaching Calls Behavioral: Healthy Living Coaching Calls Behavioral: Cancer.net app Not Applicable

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 (n=50) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
Actual Study Start Date : November 26, 2019
Actual Primary Completion Date : May 1, 2021
Actual Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fit2ThriveMB
Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
Behavioral: Fit2ThriveMB App
The Fit2thriveMB app will encourage participants to increase their physical activity. Participants will be provided with educational information on physical activity and effective behavior change strategies for incorporating more physical activity into their daily lives to increase their step count. Participants will be prompted each morning to report the intensity of their symptom burden (0 to 10). Based on their symptom rating and their previous day's step counts, participants will be provided with three different options or levels of goals for that day to either increase or decrease 10-20% or remain constant.

Behavioral: Fitbit
The Fitbit measures PA intensity, steps, and heart rate and syncs directly with the smartphone and will automatically sync with the Fit2ThriveMB app and provide Fitbit data to the study team in real-time.

Behavioral: Physical Activity Coaching Calls
Participants will receive weekly coaching calls which will: a) provide feedback on the previous week's symptom burden and progress on PA goals; b) review personalized goals and strategies for increasing PA for the next week; c) provide instruction on effective behavioral change techniques

Active Comparator: Healthy Living Control
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
Behavioral: Healthy Living Coaching Calls
Participants will receive weekly calls that will cover health and well-being topics for instance: symptom and stress management, healthy diet, hydration, sun safety, sleep hygiene, and meditation.

Behavioral: Cancer.net app
Cancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking




Primary Outcome Measures :
  1. Feasibility of a 12 week technology supported physical activity intervention in metastatic breast cancer patients [ Time Frame: 12 weeks ]
    Feasibility will be assessed via participant retention (# of participants who drop out/ # randomized).

  2. Adherence to a 12 week technology supported physical activity intervention by metastatic breast cancer patients [ Time Frame: 12 weeks ]
    Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. Tracker wear time, steps, and time spent in sedentary, light, moderate, and vigorous intensity activity will be obtained.

  3. Acceptability of a 12 week technology supported physical activity intervention to metastatic breast cancer patients [ Time Frame: 12 Weeks ]
    Acceptability will be measured via a process evaluation of perceptions of MBC patients' experiences with Fit2ThriveMB.


Secondary Outcome Measures :
  1. Physical Activity before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients [ Time Frame: 12 weeks ]
    Physical activity will be measured at baseline and at 12 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).

  2. Quality of life, as assessed by FACT-B survey, before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients [ Time Frame: 12 weeks ]
    Quality of life will be measured at baseline and 12 weeks using the Functional Assessment of Cancer Therapy-Breast (FACT-B)

  3. Symptom Burden-Anxiety [ Time Frame: 12 weeks ]
    Symptom burden of anxiety will be measured at baseline and 12 weeks using the PROMIS-Anxiety 8a health measure.

  4. Symptom Burden-Depression [ Time Frame: 12 weeks ]
    Symptom burden of depression will be measured at baseline and 12 weeks using the PROMIS-depression 8a health measure.

  5. Symptom Burden-Fatigue [ Time Frame: 12 weeks ]
    Symptom burden of fatigue will be measured at baseline and 12 weeks using the PROMIS-Fatigue 8a health measure.

  6. Symptom Burden-Pain Interference [ Time Frame: 12 weeks ]
    Symptom burden will be measured at baseline and 12 weeks using the PROMIS health measure.

  7. Symptom Burden-Physical Function [ Time Frame: 12 weeks ]
    Symptom burden will be measured at baseline and 12 weeks using the PROMIS-physical function 20 a health measure.

  8. Symptom Burden-Sleep Disturbance [ Time Frame: 12 weeks ]
    Symptom burden of sleep disturbance will be measured at baseline and 12 weeks using the PROMIS-Sleep Disturbance 8a health measure.

  9. Functional Performance before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients-Short Physical Performance Battery [ Time Frame: 12 weeks ]
    Participants will complete the Short Physical Performance Battery at baseline and 12 weeks.

  10. Functional Performance before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients-Senior Fitness Test [ Time Frame: 12 weeks ]
    Participants will complete the Senior Fitness Test at baseline and 12 weeks.

  11. Functional Performance before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients-6 minute walk test [ Time Frame: 12 weeks ]
    Participants will complete a 6 minute walk test at baseline and 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129346


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
  Study Documents (Full-Text)

Documents provided by Siobhan M Phillips, Northwestern University:
Informed Consent Form  [PDF] November 5, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Siobhan M Phillips, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04129346    
Other Study ID Numbers: SP00049673
R21CA239130 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy. We welcome inquiries by investigators who are not associated with the study to review or analyze data that we have collected. All requests for data sharing will be handled by the PI, Dr. Phillips, in conjunction with co-investigators, on a case by case basis to ensure that the proposed work does not conflict with planned analyses; we will also establish that the proposed project has sufficient scientific merit before proceeding.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siobhan M Phillips, Northwestern University:
Inactivity
Breast Cancer
Metastatic Breast Cancer
Quality of life
Sedentary
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases