Trial Outcomes & Findings for Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives) (NCT NCT05011279)

Last Updated: 2023-11-15

Results Overview

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.)

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Assessed at 4 Weeks

Results posted on

2023-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Study Participants in the pilot study will participate as members of family-based dyads (n=5 dyads) in this single arm study. 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Study n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	45.9 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Breast Cancer Status Survivor	5 Participants n=5 Participants
Breast Cancer Status Mother of a survivor, no BRCA	1 Participants n=5 Participants
Breast Cancer Status Daughter of a survivor, no BRCA	1 Participants n=5 Participants
Breast Cancer Status Sister of a survivor, no BRCA	2 Participants n=5 Participants
Breast Cancer Status Niece of a survivor, no BRCA	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at 4 Weeks

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
System Usability Scale (SUS) Score	72 units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 4 month recruitment period

the number of participants screened per month during recruitment period (not cumulative)

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Number of Participants Screened Per Month	5 Participants

SECONDARY outcome

Timeframe: 4 month enrollment period

number of participants consented to the study each month during enrollment period

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Number of Participants Enrolled Per Month	3 Participants

SECONDARY outcome

Timeframe: 4 Weeks

number of participants who completed all aspects of the protocol

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Completion Rate	10 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Number of Study Days	17.1 days Standard Deviation 8.6

SECONDARY outcome

Timeframe: during 4 month recruitment period

Number of initial respondents who consent and enroll.

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Number of Participants Recruited	1 participants

SECONDARY outcome

Timeframe: 4 weeks

Total number of participants who completed the study

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Number of Participants Completed Study	9 number of participants

SECONDARY outcome

Timeframe: Baseline to 4 Weeks

Retention will be the number who remain in the study at the end of 4 weeks

Outcome measures

Outcome measures
Measure	Pilot Study n=10 Participants 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.
Number of Participants Retained at the End of 4 Weeks	10 number of participants

Adverse Events

Single Arm of Breast Cancer Survivors (n=5) and Family Members (n=5)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Marinac

Dana-Farber Cancer Institute

Phone: 617-632-4703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place