Peer Support For Young Adult Women With High Breast Cancer Risk
Primary Purpose
Breast Cancer Risk
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PeACE
Community peer coaching
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer Risk
Eligibility Criteria
Inclusion Criteria:
- There are two targets for recruitment with different eligibility criteria.
Index carriers:
- Men or women aged 18 or older with BRCA mutations with or without 2nd-tier multiplex panel genetic testing. Index carriers will have received testing.
YARs:
- Female 1st-, 2nd- or 3rd-degree biological relatives of index carriers aged 21-30.
Exclusion Criteria:
- Must be able to speak English or Spanish and provide informed consent
Sites / Locations
- Georgetown UniversityRecruiting
- Dana Farber Cancer CenterRecruiting
- Hackensack University Medical CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PeACE peer coaching arm
Community peer coaching arm
Arm Description
Behavioral, PeACE, PeACE consists of 3 streamlined 30-minute psychosocial telephone counseling sessions delivered by a well-trained peer coach. Coaches are lay YARs from HBOC families demonstrating good knowledge, communication skills, and protocol mastery.
Behavioral, usual care, Participants in the usual care arm will receive navigation to peer support with a range of community groups who provide these services.
Outcomes
Primary Outcome Measures
Cancer-related distress
Cancer-related distress about hereditary breast and ovarian cancer risk at 12 months, gathered via self-report using the Impact of Events Scale, a 15 item measure scored on a 0-3 scale (0-45) with higher scores meaning higher distress
Decisional conflict
Decisional conflict about hereditary breast and ovarian cancer risk management decisions at 12 months gathered via self-report using the Decisional Conflict Scale. The 16 items on a 0-4 scale are summed, divided by 16 and multiplied by 25 for a total score (range=0-100); higher scores indicate higher conflict
Genetic counseling
Genetic counseling uptake at 12 months gathered via self-report (for untested women); this is a binary yes/no question
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04248257
Brief Title
Peer Support For Young Adult Women With High Breast Cancer Risk
Official Title
Peer Support For Young Adult Women With High Breast Cancer Risk
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. Study aims are to 1) Assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested YARs, 2) Identify YARs most likely to engage with and benefit from the intervention, 3) Understand intervention mechanisms. Participants will complete interviews at baseline, 1, 6, and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Risk
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PeACE peer coaching arm
Arm Type
Experimental
Arm Description
Behavioral, PeACE, PeACE consists of 3 streamlined 30-minute psychosocial telephone counseling sessions delivered by a well-trained peer coach. Coaches are lay YARs from HBOC families demonstrating good knowledge, communication skills, and protocol mastery.
Arm Title
Community peer coaching arm
Arm Type
Active Comparator
Arm Description
Behavioral, usual care, Participants in the usual care arm will receive navigation to peer support with a range of community groups who provide these services.
Intervention Type
Behavioral
Intervention Name(s)
PeACE
Intervention Description
3 session peer coaching intervention
Intervention Type
Behavioral
Intervention Name(s)
Community peer coaching
Intervention Description
Peer coaching provided by community organizations that support the HBOC community
Primary Outcome Measure Information:
Title
Cancer-related distress
Description
Cancer-related distress about hereditary breast and ovarian cancer risk at 12 months, gathered via self-report using the Impact of Events Scale, a 15 item measure scored on a 0-3 scale (0-45) with higher scores meaning higher distress
Time Frame
12 months
Title
Decisional conflict
Description
Decisional conflict about hereditary breast and ovarian cancer risk management decisions at 12 months gathered via self-report using the Decisional Conflict Scale. The 16 items on a 0-4 scale are summed, divided by 16 and multiplied by 25 for a total score (range=0-100); higher scores indicate higher conflict
Time Frame
12 months
Title
Genetic counseling
Description
Genetic counseling uptake at 12 months gathered via self-report (for untested women); this is a binary yes/no question
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Index carriers can be men and women; those taking part in peer coaching will be female.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
There are two targets for recruitment with different eligibility criteria.
Index carriers:
Men or women aged 18 or older with BRCA mutations with or without 2nd-tier multiplex panel genetic testing. Index carriers will have received testing.
YARs:
Female 1st-, 2nd- or 3rd-degree biological relatives of index carriers aged 21-30.
Exclusion Criteria:
Must be able to speak English or Spanish and provide informed consent
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne O'Neill, PhD
Phone
202-687-0869
Email
sco4@georgetown.edu
Facility Name
Dana Farber Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huma Rana, MD
Phone
617-582-9320
Email
HumaQ_Rana@dfci.harvard.edu
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Balija, MD, FACS, FSSO
Phone
551-996-1319
Email
tara.balija@hmhn.org
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jada Hamilton, PhD
Phone
646-888-0049
Email
hamiltoj@mskcc.org
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Dubard-Gault, MD, MS
Phone
206-606-6990
Email
mdg2019@uw.edu
12. IPD Sharing Statement
Learn more about this trial
Peer Support For Young Adult Women With High Breast Cancer Risk
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