Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments video and booklet, factsheet
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator National Institutes of Health (NIH)
Start date July 2012
End date February 2017
Trial size 157 participants
Trial identifier NCT02451735, MCC-16723

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:

Phase 1 - reviewing the newly developed educational materials, and Phase 2 - evaluating the effectiveness of the newly developed educational materials

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
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)
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.
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)
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.
factsheet
Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.

Primary Outcomes

Measure
Phase 1: Rate of Initial Survey Responses
time frame: Up to 8 months
Phase 2: Rate of Participation
time frame: Up to 8 months

Secondary Outcomes

Measure
Rate of Impact
time frame: Up to 8 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: Phase 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they: - are > 18 years of age; - have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis); - are capable of speaking and reading standard English; - have not attended or scheduled an upcoming appointment for genetic counseling at the time of recruitment; - are within 18 months of their breast cancer (BC) diagnosis; - have a previous diagnosis of breast cancer or; - received a referral letter for GC from their MCC physician; - breast cancer at age 50 or below; - bilateral breast cancer; - multiple cancers except basal cell carcinoma; - triple negative breast cancer; - ovarian cancer or fallopian tube cancer at any age; - of Ashkenazi Jewish descent; - have 2 or more blood relatives diagnosed with breast cancer; - have any blood relatives diagnosed with bilateral breast cancer; - a first degree relative diagnosed with breast cancer below age 50; - have blood relatives diagnosed with ovarian cancer; - have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer; - have a known cancer gene mutation (such as BRCA 1/2; - have any male relatives diagnosed with breast cancer ; and - have a mailing address and working telephone number; and - provide written informed consent. Phase 2: Female BC patients at MCC are eligible to participate if they: - are > 18 years of age; - have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis); - are capable of speaking and reading standard English; - have not attended or scheduled an upcoming appointment for GC at the time of recruitment; - have a previous diagnosis of breast cancer or; - received a referral letter for GC from their MCC physician; - breast cancer at age 50 or below; - bilateral breast cancer; - multiple cancers except basal cell carcinoma; - triple negative breast cancer; - ovarian cancer or fallopian tube cancer at any age - of Ashkenazi Jewish descent; - have 2 or more blood relatives diagnosed with breast cancer; - have any blood relatives diagnosed with bilateral breast cancer; - a first degree relative diagnosed with breast cancer below age 50; - have blood relatives diagnosed with ovarian cancer; - have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer; - have a known cancer gene mutation (such as BRCA 1/2; - have any male relatives diagnosed with breast cancer ; and - have a mailing address and working telephone number; and - provide written informed consent.

Additional Information

Official title Genetic Counseling for Breast Cancer Survivors (GC for BC)
Principal investigator Susan Vadaparampil
Description Phase 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). Phase 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.
Location data was received from the National Cancer Institute and was last updated in July 2016.