Clinical trial NCT05011279: Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)
Official title: "Sitting Less, Moving More": Designing a Digital Health Intervention for Black and African American Women Breast Cancer Survivors and Their At-risk Relatives (Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivor
Breast Cancer
Fitness Trackers
Keywords: Digital Health Intervention
Breast Cancer Survivor
Breast Cancer
Garmin Activity Tracker
Move Together App
Fitness trackers
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
name: University of Rochester
name: National Cancer Institute (NCI)
First posted: 2021-08-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health.

Detailed description: The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health.

This is a cross-sectional descriptive study using structured interviews and qualitative data analysis to develop an intervention, followed by a pilot test of the intervention with pre- /post- measures.

* In study phase 1,involved qualitative interviews with 5 community leader key informants, 9 breast cancer survivors and 6 first degree relatives of a survivor.
* This part of the research study is a Pilot Study, which means it is the first time that researchers are studying usability and acceptability of the Move Together app.

  * Participants in the pilot study will participate as members of family-based dyads (n=10 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative
  * Study involves screening for eligibility, interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch
  * Participation on the trial will be for 5 weeks
* About 20 people (10 survivors with 10 relatives) will participate in this part of the study, and a total of 58 people in the whole study.

Eligibility criteria: Inclusion Criteria:

* 1a) Key informants (for interviews)

  * Members of the community/advisory groups, community health centers, or faith-based network members (e.g., Pink and Black, Faces of Faith).
  * English speaking adults.
* (1b) Breast cancer survivors and relatives (for interviews)

  * Self-identify as Black or African American
  * Age 18 and over
  * English speaking
  * Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor
  * Self-report ever using a smart phone
* (2) Breast cancer survivors and relatives (for user testing/interviews)

  * Self-identify as Black or African American
  * Age 18 and over
  * English speaking
  * Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor
  * Self-report willing/able to download the app for testing on a smart phone
  * Self-report willing/able to meet via Zoom for interview
* (3) Breast cancer survivors and relatives/"buddies" (for pilot testing)

  * Self-identify as Black or African American
  * Age 18 and over
  * English speaking
  * Breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a blood relative, of any gender, of a so defined breast cancer survivor
  * Self-report willing/able to participate with a blood relative in survivor relative dyad
  * Self-report willing/able to download the app for use on a smart phone
  * Self-report willing/able to meet via Zoom for instructions and interview

Exclusion Criteria:

* (1a) Key informants (for interviews)

  --None
* (1b) Breast cancer survivors and relatives (for interviews)

  * Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7)
  * Pregnant women
* (2) Breast cancer survivors and relatives (for user testing/interviews)

  * Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7)
  * Pregnant women
* (3) Breast cancer survivors and relatives/"buddies" (for pilot testing)

  * Meets exclusion criterion of the Modified Physical Activity Readiness Questionnaire (PAR-Q) (modified)
  * Participated in interviews or user testing in prior phases of the study

Primary outcomes:
measure: System Usability Scale (SUS) Score
timeFrame: Assessed at 4 Weeks
Secondary outcomes:
measure: Number of Participants Screened Per Month
timeFrame: 4 month recruitment period
measure: Number of Participants Enrolled Per Month
timeFrame: 4 month enrollment period
measure: Completion Rate
timeFrame: 4 Weeks
measure: Number of Study Days
timeFrame: baseline to 4 weeks (28 days)
measure: Number of Participants Recruited
timeFrame: during 4 month recruitment period
measure: Number of Participants Completed Study
timeFrame: 4 weeks
measure: Number of Participants Retained at the End of 4 Weeks
timeFrame: Baseline to 4 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: University of Massachusetts Boston
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Catherine Marinac, PhD
role: PRINCIPAL_INVESTIGATOR
References: