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An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent, or Progressive Cancer or HIV Infection

2019年12月11日 更新者:National Cancer Institute (NCI)

Background:

  • Few resources exist for helping adolescents and young adults with cancer or HIV disease understand their changing physical, emotional and social needs when treatment is no longer effective.
  • An advance directive document called Five Wishes has had particular success with the adult population because of the consideration of personal, emotional and spiritual needs in addition to medical and legal concerns.

Objectives:

-To learn which questions in Five Wishes are useful for adolescents and young adults and to then create a new document that reflects the issues they feel are most appropriate for people with cancer or HIV disease.

Eligibility:

-Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.

Design:

  • Stage 1: Participants go through each question in Five Wishes and respond to whether they feel the questions are useful.
  • Stage 2: Participants are asked to compare each question from Five Wishes to a newly developed document based on the feedback received during first stage of the study.
  • Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter the study.

調査の概要

状態

完了

条件

詳細な説明

Background:

  • Discussing end of life (EoL) care with adolescents and young adults can be one of the most difficult aspects of living with a life threatening disease.
  • Few established resources exist to aid this population in accepting and understanding their changing physical, emotional and social needs when treatment is no longer effective. Standards in palliative care suggest that discussion of end of life issues be routine and commence soon after diagnosis.
  • While many helpful documents exist to facilitate such conversations with adults, few address the particular concerns and needs of adolescents and young adults.
  • One advance directive (AD) document, Five Wishes, has had particular success with the adult population because of the consideration of 'personal, emotional and spiritual needs' in addition to medical and legal concerns.

Objective:

  • To determine if adolescents and young adults living with advanced cancer or HIV disease feel that an AD document, such as Five Wishes, is useful in addressing end of life issues.
  • To develop and perform a pilot evaluation of a modified age-appropriate advance care planning tool for young adults and adolescents based on Five Wishes that reflects the participants opinions on which questions they feel are most useful and additional items that might be helpful.

Eligibility:

  • Age: 16 to 30 years
  • Known metastatic, progressive or recurrent cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.

Design:

-A descriptive study of attitudes of young adults (16-30 years) with cancer or HIV disease concerning the questions contained in the AD document Five Wishes as well as a comparison between Five Wishes and a modified version of that document.

研究の種類

観察的

入学 (実際)

70

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、District of Columbia、アメリカ、20007-2197
        • Georgetown University
    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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

16年~30年 (子、大人)

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

全て

説明

  • INCLUSION CRITERIA:
  • Age: 16 to 30 years
  • Patients at NIH or participating site must have 1) a diagnosis of metastatic, recurrent, or progressive cancer with a mean survival rate of 2 years or less or 2) a diagnosis of perinatal or early life transfusion associated HIV infection. The treatment protocol PI or attending physician must consent to have a patient entered into this protocol. Newly diagnosed patients must have completed at least three cycles of chemotherapy.
  • For patients less than 18 years of age, a legal guardian must provide informed consent and the patients must sign an assent document.
  • Patients greater than 18 years of age must give informed consent.
  • Patients less than 18 years of age must have a score of 40 or higher on Lanksy/Karnofsky, as determined by the medical team at the time of enrollment.
  • Patients greater than 18 years of age must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) at the time of enrollment.
  • Patients must be English or Spanish speaking.

EXCLUSION CRITERIA:

  • Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator, or consulting psychiatrist would compromise the patient s ability to engage in the intervention or is likely to interfere with the study procedures or results.
  • Previously identified cognitive impairment which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to understand the Five Wishes material or is likely to interfere with the study procedures or results.
  • Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the research team would compromise the patient s ability to tolerate this study

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

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。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2007年1月26日

研究の完了

2014年9月25日

試験登録日

最初に提出

2011年9月30日

QC基準を満たした最初の提出物

2011年9月30日

最初の投稿 (見積もり)

2011年10月3日

学習記録の更新

投稿された最後の更新 (実際)

2019年12月12日

QC基準を満たした最後の更新が送信されました

2019年12月11日

最終確認日

2014年9月25日

詳しくは

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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