Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U54CA156732 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Massachusetts, Boston | OTHER |
| University of Rochester | OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Study | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Move Together app/Garmin Activity Tracker | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | Assessed at 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Screened Per Month | the number of participants screened per month during recruitment period (not cumulative) | 4 month recruitment period |
| Number of Participants Enrolled Per Month |
Not provided
Inclusion Criteria:
1a) Key informants (for interviews)
(1b) Breast cancer survivors and relatives (for interviews)
(2) Breast cancer survivors and relatives (for user testing/interviews)
(3) Breast cancer survivors and relatives/"buddies" (for pilot testing)
Exclusion Criteria:
(1a) Key informants (for interviews)
--None
(1b) Breast cancer survivors and relatives (for interviews)
(2) Breast cancer survivors and relatives (for user testing/interviews)
(3) Breast cancer survivors and relatives/"buddies" (for pilot testing)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Marinac, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| University of Massachusetts Boston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37223968 | Derived | Blazey M, Marinac C, Whiteley J, Peterson S, Burns White K, Jacques C, Lam H, Halpenny B, Patel S, Lamothe R, Wright J. Designing a Dyad-Based Digital Health Intervention to Reduce Sedentary Time in Black Breast Cancer Survivors and Their First-degree Relatives: Human-Centered Design Study. JMIR Form Res. 2023 May 24;7:e43592. doi: 10.2196/43592. |
Not provided
Not provided
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
number of participants consented to the study each month during enrollment period
| 4 month enrollment period |
| Completion Rate | number of participants who completed all aspects of the protocol | 4 Weeks |
| 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) | baseline to 4 weeks (28 days) |
| Number of Participants Recruited | Number of initial respondents who consent and enroll. | during 4 month recruitment period |
| Number of Participants Completed Study | Total number of participants who completed the study | 4 weeks |
| 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 | Baseline to 4 Weeks |
| Boston |
| Massachusetts |
| 02125 |
| United States |
| University of Rochester | Rochester | New York | 14627 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
this includes 5 survivors and 5 relatives
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Breast Cancer Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | Posted | Mean | Standard Deviation | units on a scale | Assessed at 4 Weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Screened Per Month | the number of participants screened per month during recruitment period (not cumulative) | Posted | Count of Participants | Participants | 4 month recruitment period |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Enrolled Per Month | number of participants consented to the study each month during enrollment period | Posted | Count of Participants | Participants | 4 month enrollment period |
|
| ||||||||||||||||||||||||||||
| Secondary | Completion Rate | number of participants who completed all aspects of the protocol | Posted | Count of Participants | Participants | 4 Weeks |
|
| ||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | days | baseline to 4 weeks (28 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Recruited | Number of initial respondents who consent and enroll. | Posted | Number | participants | during 4 month recruitment period |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Completed Study | Total number of participants who completed the study | Posted | Number | number of participants | 4 weeks |
|
| ||||||||||||||||||||||||||||
| 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 | Posted | Number | number of participants | Baseline to 4 Weeks |
|
|
5 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm of Breast Cancer Survivors (n=5) and Family Members (n=5) | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Marinac | Dana-Farber Cancer Institute | 617-632-4703 | CatherineR_Marinac@dfci.harvard.edu |
| Dec 27, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Daughter of a survivor, no BRCA |
|
| Sister of a survivor, no BRCA |
|
| Niece of a survivor, no BRCA |
|
|
|
|
|
|
|
|