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

2017年5月16日 更新者:Georgetown University

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

245

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • District of Columbia
      • Washington, D.C.、District of Columbia、アメリカ、20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

8年~120年 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Self-reported outcomes at 1-and 6-months
時間枠:6 months
6 months
Decision conflict, as assessed by the Decisional Conflict Scale
時間枠:6 months
6 months
Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
時間枠:6 months
6 months
Decision quality
時間枠:6 months
6 months
Disclosure of genetic testing results by parents
時間枠:6 months
6 months
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
時間枠:6 months
6 months
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
時間枠:6 months
6 months
Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling
時間枠:6 months
6 months
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
時間枠:6 months
6 months
Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children
時間枠:6 months
6 months
Parents' preferences and values regarding family communication of genetic test results
時間枠:6 months
6 months
Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale
時間枠:6 months
6 months
Cognitive appraisals
時間枠:6 months
6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Kenneth Tercyak, PhD、Lombardi Comprehensive Cancer Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年3月1日

一次修了 (実際)

2013年2月1日

研究の完了 (実際)

2015年12月1日

試験登録日

最初に提出

2008年5月24日

QC基準を満たした最初の提出物

2008年5月24日

最初の投稿 (見積もり)

2008年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2017年5月17日

QC基準を満たした最後の更新が送信されました

2017年5月16日

最終確認日

2017年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CDR0000592726
  • P30CA051008 (米国 NIH グラント/契約)
  • R01HG002686 (米国 NIH グラント/契約)
  • GUMC-2007-444

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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