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
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
157
Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.
Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Part 1: Rate of Initial Survey Responses
Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
Time frame: Up to 8 months
Part 2: Rate of Participation
Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
Time frame: Up to 8 months
Rate of Impact
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.
Time frame: Up to 8 months
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