Genetic Counseling for Breast Cancer Survivors (GC for BC)

NCT02451735 | Completed

• 1 other identifier: MCC-16723
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

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

Outcome Measures

Primary Outcomes (2)

• Part 1: Rate of Initial Survey Responses

  Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.

  Up to 8 months

• Part 2: Rate of Participation

  Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.

  Up to 8 months

Secondary Outcomes (1)

• Rate of Impact

  Up to 8 months

Study Arms (3)

Intervention Development

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.

Intervention Pilot - Intervention Group

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.

Behavioral: Video and Booklet

Intervention Pilot - Control Group

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.

Behavioral: Factsheet

Interventions

Video and Booklet BEHAVIORAL

Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.

Intervention Pilot - Intervention Group

Factsheet BEHAVIORAL

Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.

Intervention Pilot - Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Susan Vadaparampil

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 22, 2015
• Study Start: July 27, 2012
• Primary Completion: July 11, 2016
• Study Completion: July 12, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

US (1)