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

• ClinicalTrials.gov Identifier: NCT05011279
• Recruitment Status: Completed
• First Posted: August 18, 2021
• Results First Posted: May 8, 2023
• Last Update Posted: November 15, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: University of Massachusetts, Boston; University of Rochester; National Cancer Institute (NCI)
• Information provided by (Responsible Party): Catherine Marinac, PhD, Dana-Farber Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Conditions: Breast Cancer Survivor; Breast Cancer; Fitness Trackers
• Intervention: Other: Move Together app/Garmin Activity Tracker
• Enrollment: 10

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Pilot Study
Arm/Group Description	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.
Period Title: Overall Study
Started	10 [1]
Completed	10 [1]
Not Completed	0
[1] 5 survivors and 5 relatives

Baseline Characteristics

Arm/Group Title		Pilot Study
Arm/Group Description		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.
Overall Number of Baseline Participants		10
Baseline Analysis Population Description		this includes 5 survivors and 5 relatives
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	8 80.0%
	>=65 years	2 20.0%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	10 participants
		45.9; (22 to 70)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	Female	10 100.0%
	Male	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	10 100.0%
	White	0 0.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	10 participants
		10
Breast Cancer Status; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	Survivor	5 50.0%
	Mother of a survivor, no BRCA	1 10.0%
	Daughter of a survivor, no BRCA	1 10.0%
	Sister of a survivor, no BRCA	2 20.0%
	Niece of a survivor, no BRCA	1 10.0%

Outcome Measures

1. Primary Outcome

Title	System Usability Scale (SUS) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Mean (Standard Deviation); Unit of Measure: units on a scale
	72 (14.3)

2. Secondary Outcome

Title	Number of Participants Screened Per Month
Description	the number of participants screened per month during recruitment period (not cumulative)
Time Frame	4 month recruitment period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	5 50.0%

3. Secondary Outcome

Title	Number of Participants Enrolled Per Month
Description	number of participants consented to the study each month during enrollment period
Time Frame	4 month enrollment period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	3 30.0%

4. Secondary Outcome

Title	Completion Rate
Description	number of participants who completed all aspects of the protocol
Time Frame	4 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	10 100.0%

5. Secondary Outcome

Title	Number of Study Days
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Mean (Standard Deviation); Unit of Measure: days
	17.1 (8.6)

6. Secondary Outcome

Title	Number of Participants Recruited
Description	Number of initial respondents who consent and enroll.
Time Frame	during 4 month recruitment period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Number; Unit of Measure: participants
	1

7. Secondary Outcome

Title	Number of Participants Completed Study
Description	Total number of participants who completed the study
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Number; Unit of Measure: number of participants
	9

8. Secondary Outcome

Title	Number of Participants Retained at the End of 4 Weeks
Description	Retention will be the number who remain in the study at the end of 4 weeks
Time Frame	Baseline to 4 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pilot Study
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Number; Unit of Measure: number of participants
	10

Adverse Events

Time Frame	5 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Single Arm of Breast Cancer Survivors (n=5) and Family Members (n=5)
Arm/Group Description	Participants in the single arm 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.
All-Cause Mortality
	Single Arm of Breast Cancer Survivors (n=5) and Family Members (n=5)
	Affected / at Risk (%)
Total	0/10 (0.00%)
Serious Adverse Events
	Single Arm of Breast Cancer Survivors (n=5) and Family Members (n=5)
	Affected / at Risk (%)
Total	0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Single Arm of Breast Cancer Survivors (n=5) and Family Members (n=5)
	Affected / at Risk (%)
Total	0/10 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Catherine Marinac
• Organization: Dana-Farber Cancer Institute
• Phone: 617-632-4703
• EMail: CatherineR_Marinac@dfci.harvard.edu

• Responsible Party: Catherine Marinac, PhD, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT05011279
• Other Study ID Numbers: 20-104; U54CA156732 ( U.S. NIH Grant/Contract )
• First Submitted: August 13, 2021
• First Posted: August 18, 2021
• Results First Submitted: December 28, 2022
• Results First Posted: May 8, 2023
• Last Update Posted: November 15, 2023