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Completed

NCT Number: NCT01346761

Risk Education and Assessment for Cancer Heredity

Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this disparity in access to such services. However, before the widespread adoption of telephone-delivered cancer genetic services occurs, it is critical to analyze the efficacy and safety of this mode of communication. This two-group randomized equivalency/non-inferiority trial will determine whether telephone-based cancer genetic counseling is an acceptable alternative to the traditional in-person mode among women who have a personal or family history of breast and/or ovarian cancer strong enough to warrant genetic counseling and testing. This study's findings will provide important information to cancer centers and cancer control policies about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for geographically challenged women at risk for having Breast Cancer susceptibility gene (BRCA) 1/2 mutations.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Disease Attributes Disease Susceptibility Endocrine Gland Neoplasms Endocrine System Diseases Fanconi Anemia, Complementation Group D1 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Predisposition Genetic Predisposition to Disease Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

25 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84118, United States

About this study

Following confirmation of eligibility and completion of baseline surveys, participants will be randomly assigned to one of the study arms by the project coordinator, using a computer-generated allocation algorithm on the basis of a randomization blocks method using four, six or eight participants in each block.

In-person and telephone counseling will be delivered by the same board-certified genetic counselors using a guideline-concordant semi-structured protocol that will allow for personalization of counseling.

Participants randomly assigned to telephone counseling will be mailed packets that include a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer genetic counseling with visual aids. At the time of their session, participants will review the brochure and genetic counselors will use visual aids to explain breast-ovarian cancer genetics. Women receiving in-person counseling will be given the same materials during their session at the community clinic.

For women who elect to have testing, those who have telephone counseling will be sent a genetic test kit; those who have in-person counseling will have the option of giving a sample immediately at the clinic, or will be given a test kit with the same instructions as those in the telephone-counseling group.

When BRCA test results become available, participants will be offered individual post-test counseling with the same genetic counselor who conducted the pretest session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Utah resident
  • Meets National Comprehensive Cancer Network (NCCN) guidelines for hereditary breast/ovarian cancer syndrome (personal and/or family history of breast and/or ovarian cancer, or is a member of a family with a known positive BRCA1/BRCA2 mutation).

Exclusion criteria

  • Has had genetic counseling and/or BRCA 1/2 testing
  • Physically or mentally unable to complete telephone surveys, telephone or in-person counseling or provide informed consent.
  • Unable to read and speak English fluently
  • Unable to travel to in-person genetic counseling session (17 in-person sites throughout Utah)
  • Male gender

Treatment and study plan

Telephone Genetic Counseling

Behavioral

Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor over the telephone. Counseling sessions will be audiotaped for quality control of intervention.

Other names: BRCA1/BRCA2 genetic counseling via telephone

In-Person Genetic Counseling

Behavioral

Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor in person. Counseling sessions will be audiotaped for quality control of intervention.

Other names: BRCA1/BRCA2 traditional genetic counseling in-person

Primary outcomes

  1. Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling

    Time frame: 6 &12-month follow-up

    • Compare utilization of BRCA1/BRCA2 testing among telephone genetic counseling relative to in-person genetic counseling.
    • Determine the safety and efficacy of telephone genetic counseling relative to in-person genetic counseling by evaluating psychological and quality of life outcomes.
    • Compare communication-related and decision-making outcomes among telephone genetic counseling relative to in-person genetic counseling.

Secondary outcomes

  1. Determine the feasibility of the intervention

    Time frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups

    • Examine the intervention delivery and patient costs of telephone genetic counseling relative to in-person genetic counseling.
    • Examine mediators (sociodemographic, communication factors, health care access, clinical, & psychosocial factors) of genetic testing decisions, and affective and cognitive outcomes.
    • Compare decisions and perceptions about use of primary/secondary prevention strategies for hereditary breast/ovarian cancer.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women

Acronym: REACH

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 3, 2011
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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