Clinical trial · Interventional
Genetic Counseling for Breast Cancer Survivors (GC for BC)
NCT02451735CI-TRIAL-00041525completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Factsheet | Behavioral | — | UNRESOLVED |
| Video and Booklet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Intervention Development
- description
- 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.
- type
- EXPERIMENTAL
- label
- Intervention Pilot - Intervention Group
- description
- 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.
- interventionNames
- Behavioral: Video and Booklet
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.