Genetic Counseling for Breast Cancer Survivors (GC for BC)
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|ClinicalTrials.gov Identifier: NCT02451735|
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : November 8, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Video and Booklet Behavioral: Factsheet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Genetic Counseling for Breast Cancer Survivors (GC for BC)|
|Actual Study Start Date :||July 27, 2012|
|Actual Primary Completion Date :||July 11, 2016|
|Actual Study Completion Date :||July 12, 2019|
No Intervention: Intervention Development
Psychoeducational Intervention (PEI) development. PEIs include printed and DVD materials, and represent a commonly used and effective approach to implement theoretically based individual-level interventions. These materials serve as important sources of information for the general public, cancer patients, and survivors from a variety of backgrounds, including populations with limited health literacy. An interview and feedback collection process will take place to provide data to improve current PEI materials.
Experimental: Intervention Pilot - Intervention Group
The intervention group will receive the PEI materials: video and booklet. Self-reported feedback will be collected and reviewed to compare response with the control group.
Behavioral: Video and Booklet
Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.
Active Comparator: Intervention Pilot - Control Group
The control group will receive a patient factsheet about Genetic Counseling (GC). Self-reported feedback will be collected and reviewed to compare response with the intervention group.
Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.
- Part 1: Rate of Initial Survey Responses [ Time Frame: Up to 8 months ]Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
- Part 2: Rate of Participation [ Time Frame: Up to 8 months ]Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
- Rate of Impact [ Time Frame: Up to 8 months ]Self-Reported Feedback Scoring Method: Frequencies and descriptives will be calculated for response options. Positive feedback rate of Psychoeducational Intervention (PEI) group compared to the Factsheet group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451735
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Susan Vadaparampil||H. Lee Moffitt Cancer Center and Research Institute|