NCT03323333

Brief Summary

A brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring BRCA genetic alterations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

October 24, 2017

Last Update Submit

October 25, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Communication of genetic test results

    A binary (yes/no) epidemiological item to determine if parental communication of genetic test results occurred to the child.

    1 Month

Study Arms (1)

Intervention

EXPERIMENTAL
Behavioral: psychosocial counseling

Interventions

psychosocial counselingBEHAVIORAL

A problem-solving and psychosocial skill-building intervention.

Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, married/partnered status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

September 4, 2014

Primary Completion

June 26, 2017

Study Completion

June 26, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share