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Breast CancerPhase 3NCT00685256

Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children

A Phase 3 study testing counseling intervention, educational intervention and survey administration in people with Breast Cancer and Hereditary Breast/Ovarian Cancer (brca1, brca2), run by Georgetown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children. Read more about this study

Who is it for?
Ages 8 to 120 years, women only
What is being tested?
counseling intervention, educational intervention and survey administration
How many people
245 participants
Where
2 sitesUnited States
Study dates
Mar 2008to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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

RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children.

PURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.

Read the detailed description

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.

Being tested
counseling intervention, educational intervention, survey administration, psychosocial assessment and care, supportive care
Keywords
breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2)
Medical subject headings
Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • counseling interventionOther

    subjects and parents will receive genetic counseling

  • educational interventionOther

    subjects and parents will receive education re: genetic testing

  • survey administrationOther

    surveys will be administered to subjects and parents

  • psychosocial assessment and careBehavioural

    psychosocial assessment and counseling will be provided

  • supportive careBehavioural

    parents and children will be provided with supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported outcomes at 1-and 6-months

    Measured: 6 months

  2. Decision conflict, as assessed by the Decisional Conflict Scale

    Measured: 6 months

  3. Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale

    Measured: 6 months

  4. Decision quality

    Measured: 6 months

  5. Disclosure of genetic testing results by parents

    Measured: 6 months

  6. Child-rearing alliance between parents, as measured by the Parenting Alliance Measure at baseline, after learning test results, and at 1 and 6 months after genetic counseling

    Measured: 6 months

  7. Parent-child communication, as assessed by the Parent-Adolescent Communication Scale at baseline, after learning test results, and at 1 and 6 months after genetic counseling

    Measured: 6 months

  8. Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling

    Measured: 6 months

  9. Children's stress and worry, as assessed by the Child Behavior Checklist at baseline, after learning test results, and at 1 and 6 months after genetic counseling

    Measured: 6 months

  10. Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children

    Measured: 6 months

  11. Parents' preferences and values regarding family communication of genetic test results

    Measured: 6 months

  12. Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale

    Measured: 6 months

  13. Cognitive appraisals

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionFeb 2013
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685256
Sponsor's protocol ID
CDR0000592726
Other IDs
R01HG002686, P30CA051008, GUMC-2007-444
Status last verified
Feb 2017
First submitted
24 May 2008
Last updated
17 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing counseling intervention, educational intervention and survey administration in people with Breast Cancer and Hereditary Breast/Ovarian Cancer (brca1, brca2), run by Georgetown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported outcomes at 1-and 6-months (time frame: 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.

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Clinical Trial NCT00685256 | AzTrials