若年成人がん患者とそのパートナー介護者のための二者択一介入 (YAD)
The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.
調査の概要
状態
詳細な説明
Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital Cancer Center
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Concord、Massachusetts、アメリカ、01742
- Emerson Hospital/MGH Cancer Center
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Danvers、Massachusetts、アメリカ、01923
- Mass General at North Shore Cancer Center
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Newton、Massachusetts、アメリカ、02462
- Mass General at Newton Wellesley Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)
- Either: (1) Indicates a score ≥4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score ≥4 on the NCCN adapted distress thermometer study screening questions
- English-speaking
Exclusion Criteria:
• Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
研究計画
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：支持療法
- 割り当て：なし
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Young Adults Coping with Cancer Together Intervention
Young adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks. |
This intervention is based on cognitive-behavioral therapy and couples' therapy. It aims to improve cancer and caregiving-related self-efficacy and coping, as well as promote relationship maintenance in context of cancer. The intervention will be delivered by a trained mental health practitioner and include didactics, experiential exercises, and home practice.
他の名前：
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of Intervention
時間枠：14 +/- 2 Weeks
|
Feasibility will be measured by participant rates of enrollment (≥50% of eligible participants enroll), participant retention (≥70% complete the 14-week post-baseline assessment), and intervention attendance (≥70% of participants attending at least 6 of 8 sessions). |
14 +/- 2 Weeks
|
|
Acceptability of Intervention
時間枠：14 +/- 2 Weeks
|
Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥75% of participants report average satisfaction that exceeds the CSQ's midpoint. |
14 +/- 2 Weeks
|
協力者と研究者
捜査官
- 主任研究者：Jamie M Jacobs, Ph.D.、Massachusetts General Hospital
- 主任研究者：Giselle K Perez, Ph.D.、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: jjacobs@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共有時間枠
Data can be shared no earlier than 1 year following the date of publication
IPD 共有アクセス基準
Contact the Partners Innovations team
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。