Breast Cancer, Breast Cancer Survivor, Fitness Trackers
Conditions
Keywords
Digital Health Intervention, Breast Cancer Survivor, Breast Cancer, Garmin Activity Tracker, Move Together App, Fitness trackers
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.
Interventions
OTHERMove Together app/Garmin Activity Tracker
* The Move Together app allows users to set daily goals for increasing physical activity and decreasing sedentary time, track progress on goals, message their buddy, and access external educational infographics and other resource links. * Garmin activity tracker in this study is for participants to track their steps and sedentary time.
Sponsors
University of Massachusetts, Boston
University of Rochester
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) Score | Assessed at 4 Weeks | The acceptability of the Move Together app will also be assessed with The System Usability Scale (SUS) score. The scale has 10 items. Scores range from 0-100; a SUS score above a 68 is considered above average (https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled Per Month | 4 month enrollment period | number of participants consented to the study each month during enrollment period |
| Completion Rate | 4 Weeks | number of participants who completed all aspects of the protocol |
| Number of Study Days | baseline to 4 weeks (28 days) | number of study days in which the participants uses the Move Together app and will describe engagement with the app in a 28 day period (i.e., study days) |
| Number of Participants Screened Per Month | 4 month recruitment period | the number of participants screened per month during recruitment period (not cumulative) |
| Number of Participants Completed Study | 4 weeks | Total number of participants who completed the study |
| Number of Participants Retained at the End of 4 Weeks | Baseline to 4 Weeks | Retention will be the number who remain in the study at the end of 4 weeks |
| Number of Participants Recruited | during 4 month recruitment period | Number of initial respondents who consent and enroll. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilot Study Participants in the pilot study will participate as members of family-based dyads (n=5 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative.
Study involves interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch
Move Together app/Garmin Activity Tracker: - The Move Together app allows users to set daily goals for increasing physical activity and decreasing sedentary time, track progress on goals, message their buddy, and access external educational infographics and other resource links.
-Garmin activity tracker in this study is for participants to track their steps and sedentary time. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pilot Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 45.9 years |
| Breast Cancer Status Daughter of a survivor, no BRCA | 1 Participants |
| Breast Cancer Status Mother of a survivor, no BRCA | 1 Participants |
| Breast Cancer Status Niece of a survivor, no BRCA | 1 Participants |
| Breast Cancer Status Sister of a survivor, no BRCA | 2 Participants |
| Breast Cancer Status Survivor | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
System Usability Scale (SUS) Score
The acceptability of the Move Together app will also be assessed with The System Usability Scale (SUS) score. The scale has 10 items. Scores range from 0-100; a SUS score above a 68 is considered above average (https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html.)
Time frame: Assessed at 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Study | System Usability Scale (SUS) Score | 72 units on a scale | Standard Deviation 14.3 |
Secondary
Completion Rate
number of participants who completed all aspects of the protocol
Time frame: 4 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Study | Completion Rate | 10 Participants |
Secondary
Number of Participants Completed Study
Total number of participants who completed the study
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Study | Number of Participants Completed Study | 9 number of participants |
Secondary
Number of Participants Enrolled Per Month
number of participants consented to the study each month during enrollment period
Time frame: 4 month enrollment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Study | Number of Participants Enrolled Per Month | 3 Participants |
Secondary
Number of Participants Recruited
Number of initial respondents who consent and enroll.
Time frame: during 4 month recruitment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Study | Number of Participants Recruited | 1 participants |
Secondary
Number of Participants Retained at the End of 4 Weeks
Retention will be the number who remain in the study at the end of 4 weeks
Time frame: Baseline to 4 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Study | Number of Participants Retained at the End of 4 Weeks | 10 number of participants |
Secondary
Number of Participants Screened Per Month
the number of participants screened per month during recruitment period (not cumulative)
Time frame: 4 month recruitment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Study | Number of Participants Screened Per Month | 5 Participants |
Secondary
Number of Study Days
number of study days in which the participants uses the Move Together app and will describe engagement with the app in a 28 day period (i.e., study days)
Time frame: baseline to 4 weeks (28 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Study | Number of Study Days | 17.1 days | Standard Deviation 8.6 |