Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-29 @ 1:06 AM
Study NCT ID:
NCT02451735
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2015-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Counseling for Breast Cancer Survivors (GC for BC)
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
Genetic Counseling for Breast Cancer Survivors (GC for BC)
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to review and evaluate the effectiveness of new educational materials (informational booklet \& DVD) that promote participation in genetic counseling among breast cancer survivors.
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
Detailed Description:
Part 1: Intervention Development
Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).
Part 2: Intervention Pilot
Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC patients and health care professionals.
Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical care. We hypothesize that women in the intervention group will have higher uptake of GC, greater increases in knowledge, and more perceived benefits related to GC compared to the control group.
Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).
Part 2: Intervention Pilot
Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC patients and health care professionals.
Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical care. We hypothesize that women in the intervention group will have higher uptake of GC, greater increases in knowledge, and more perceived benefits related to GC compared to the control group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: