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Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children


Phase 3
8 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)

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Trial Information

Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children


OBJECTIVES:

Primary

- To evaluate the efficacy of a decision support intervention delivered in conjunction
with standard genetic counseling compared to standard genetic counseling alone in
improving communication between mothers undergoing BRCA1/2 testing and their minor-age
children.

Secondary

- To understand the mechanisms by which decision support impacts on decision outcomes.

- To identify mothers who are most and least likely to benefit from decision support.

- To explore the potential impact of decision support on disclosure and parent-child
psychosocial well-being.

OUTLINE: This is a multicenter study. Mothers are stratified according to their child's age
(< 13 vs ≥ 13 years old), child's gender (female vs male), and trial site. Mothers are
randomized to 1 of 2 arms.

- Arm I (standard genetic counseling with communication aid): Mothers undergo standard
pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers
also receive a copy of "My Children, My Test Results," a detailed decision guide
developed to promote quality and informed decision making and outcomes, and provide
support to mothers regardless of whether or not they choose to communicate their
BRCA1/2 test results to their children.

- Arm II (standard genetic counseling alone): Mothers undergo standard pre-test genetic
counseling and provide a blood sample for mutation analysis. Mothers also receive a
copy of "Genetic Testing for Breast and Ovarian Cancer Risk: It's Your Choice"
containing information regarding family history of breast and ovarian cancer risks,
BRCA1/2 genes, risks and benefits of genetic testing, medical management options for
carriers, and considerations including family communication.

All mothers complete extensive family history assessments during their baseline interviews
and disclose if they have been diagnosed with cancer, length and type of treatments, and the
number of other relatives with a history of cancer. Mothers are assessed at baseline
(pre-test genetic counseling), post-genetic counseling after learning test results, and at 1
and 6 months post-genetic counseling by a 30-45 minute multi-item and multi-scale
self-report telephone survey. Genetic testing results are also submitted to this study. The
frequency (number), intensity (length in minutes), and content of participant-initiated
telephone contacts to genetic counselors to assess intervention reactivity; participants'
self-reported use of educational guides; and their satisfaction with the intervention will
be assessed.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Mothers self-identified as primary caregivers to minor-age children (ages 8-21
years-old)

- Mothers must be undergoing genetic counseling and have provided a blood sample for
analysis for BRCA1/2 mutations

- Mothers must have resided in the same home as the child(ren) for the past 6 months
and intend to continue to reside with the child(ren) for the next 6 months

PATIENT CHARACTERISTICS:

- At least 21 years old (mothers)

- No serious mental illness (e.g., cognitive and psychotic disorders) or developmental
disability that would limit participation or preclude informed consent

- Must be able to adequately understand, speak, and read English

- Must have ready and consistent access to a telephone

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Self-reported outcomes at 1-and 6-months

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Kenneth Tercyak, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000592726

NCT ID:

NCT00685256

Start Date:

March 2008

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • breast cancer
  • hereditary breast/ovarian cancer (BRCA1, BRCA2)
  • Breast Neoplasms
  • Ovarian Neoplasms

Name

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115