Breast Cancer
Conditions
Keywords
female breast cancer, bilateral breast cancer, triple negative breast cancer, breast cancer diagnosis, BRCA 1, BRCA 2, psychoeducational intervention (PEI), genetic counseling, hereditary breast and ovarian cancer (HBOC), cancer education materials
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
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.
Interventions
BEHAVIORALVideo and Booklet
Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.
BEHAVIORALFactsheet
Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.
Sponsors
National Institutes of Health (NIH)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part 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. Part 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Rate of Initial Survey Responses | Up to 8 months | Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation. |
| Part 2: Rate of Participation | Up to 8 months | Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Impact | 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. |
Countries
United States
Outcome results
None listed