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The Computerized Retraining and Functional Treatment - Group Intervention (CRAFT-G)

2026年5月11日 更新者：Hadassah Medical Organization

The Computerized Retraining and Functional Treatment: Effectiveness-implementation Hybrid Trial of Group Teleintervention Among Breast Cancer Survivors With Cognitive Impairment

The goal of this clinical trial is to examine the efficacy of a novel, remotely-applied group intervention, Cognitive Retraining and Functional Treatment Group (CRAFT-G), designed to improve cognitive function, mental health and functional outcome in breast cancer survivors (BCS) with Cancer-Related Cognitive Impairment (CRCI) while simultaneously collecting data on the barriers and facilitators of implementation in clinical settings. The main question it aims to answer is:

We hypothesize that participants receiving CRAFT-G will show gains in mental health, cognitive and daily function, and that the CRAFT-G benefits will endure for three months following treatment completion.

Participants assigned to the waitlist control will crossover to the CRAFT-G intervention group after 6 weeks.

Participants will ask to complete CRAFT-G intervention, which include:

  • Six remote group sessions (1.5hr each)
  • Between the sessions, participants will be guided to complete CRCI-specific computerized cognitive training (CCT) 3 times per week delivered using dedicated app.
  • Psychoeducation materials Assessment will take place in 3 time points: before intervention (frontal meeting for baseline assessment), post intervetion and 3 months post intervention.

The study will be conducted to explore implementation barriers and facilitators. This will be done by endline qualitative interviews with the participants' research group.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Breast cancer survivors are at risk of cancer-related cognitive impairment (CRCI), impacting their daily lives and well-being currently without satisfactory solutions. In our previous research, we developed Cognitive Retraining and Functional Treatment (CRAFT), combining computerized cognitive training with personalized approach which target daily functioning. We confirmed CRAFT's feasibility and effectiveness for CRCI through a large control trial, improving perceived cognition, cognitive performance, and daily life participation. Mental health challenges and limited access to rehabilitation programs further complicate post-breast cancer care. To address these issues, we propose a telemedicine approach that combines individualized CRAFT with group therapy (CRAFT-G) providing patients with peer-support, interpersonal learning, socialization, and normalization of their experience. CRAFT-G includes six remote group sessions led by an occupational therapist, focusing on goal setting and plan development. The content of the meetings will be adapted from the cognitive orientation to occupational performance (CO-OP) approach accompanied with relevant psychoeducation materials. In addition, participants engage in weekly cognitive training using dedicated app. Following a successful pilot study, we propose a two-step trial: the first step involves testing treatment efficacy and endurance in 48 patients (4 groups, n=24 control group), while the second step involves qualitative interviews with participants to identify barriers and facilitators to clinical implementation. The use of a novel, remotely applied group format intervention further extends the reach of care from the clinical setting to the home setting, providing a feasible and cost-effective treatment option that helps bridge the current therapeutic gaps for BCS experiencing CRCI. Our study aligns with cancer care recommendations by examining intervention effectiveness and implementation strategies and suggest a pragmatic intervention ready to be in real-world setting.

研究の種類

介入

入学 (推定)

48

段階

  • 適用できない

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。

研究連絡先

研究場所

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. women, 18 years old and older
  2. A subjective concern about declines in cognitive functioning related to a diagnosis of breast cancer and/or cancer related treatment
  3. Objective cognitive decline with no dementia (19<MOCA)
  4. 6 months or more after completion of an active treatment for cancer
  5. Daily access to the internet and sufficient basic skills to operate a computer

Exclusion Criteria:

  • Unstable psychiatric or other health condition according to participants' self-report and medical file.

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：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • 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
実験的：Cognitive Retraining and Functional Treatment Group (CRAFT-G) intervention
CRAFT-G include six remote group sessions (1.5hr each) led by an occupational therapist. The content of the meetings will be adapted from the cognitive orientation to occupational performance (CO-OP) approach accompanied with relevant psychoeducation materials. Between the sessions, participants will be guided to complete Cancer-related cognitive impairment (CRCI)-specific computerized cognitive training (CCT) 3 times per week delivered using dedicated app. In addition, psychoeducation materials will be delivered during group sessions.
行動：CRAFT-G
CRAFT-G include six remote group sessions (1.5hr each) led by an occupational therapist. The content of the meetings will be adapted from the cognitive orientation to occupational performance (CO-OP) approach accompanied with relevant psychoeducation materials. Between the sessions, participants will be guided to complete Cancer-related cognitive impairment (CRCI)-specific computerized cognitive training (CCT) 3 times per week delivered using dedicated app. In addition, psychoeducation materials will be delivered during group sessions.
実験的：Computerized cognitive training group
Participants opting for the cognitive training group will undergo computerized cognitive training (CCT), similar in content and duration to that provided in the CRAFT-G intervention group.
他の：CCT
Participants opting for the cognitive training group will undergo computerized cognitive training (CCT), similar in content and duration to that provided in the CRAFT-G intervention group.

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
Functional Assessment of Cancer Therapy - Cognition (FACT COG)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
A self-report questionnaire for cancer patients capturing subjective experiences of cognitive decline. The participants are asked to rate the items on a five-level scale ranging from 0="never" or "not at all" to 4="several times a day" or "very much;" higher scores represent better perceived cognitive function and QoL. Minimal clinically important difference (MCID) for the FACT-Cog was found to range from +4.7% to +7.2% for improvement (Liang et al., 2019), and -6.9 to -10.6 points for reduction.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The Canadian Occupational Performance Measure (COPM)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
A semi-structured interview used to assess the self-perception of clients' performance and satisfaction with performance in individual functional goals. The goals are quantified by rating importance, performance, and satisfaction on a 10-point Likert scale. A higher score indicates a greater outcome. A two-point difference between measurements taken at different time points is considered the Minimal Clinically Important Difference (MCID).
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The Performance Quality Rating Scale (PQRS)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The PQRS is used in conjunction with the COPM, to compliment the client's perceived performance with actual performance or client's self-report performance of the client-selected goal. The researcher or clinician rates the performance on a scale of 1 (the skill is not done well) to 10 (the skill is performed very well). A two-point difference between measurements taken at different time points is considered the Minimal Clinically Important Difference (MCID).
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

二次結果の測定

結果測定
メジャーの説明
時間枠
Online cognitive assessment battery
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
Cognitive assessment will be conducted using the Effectivate online cognitive training platform, which includes four tasks assessing the following cognitive domains: (1) processing speed, (2) executive attention, (3) nonverbal visual memory and binding, and (4) declarative and working memory. Performance will be evaluated based on differences in mean response time and percentage of correct responses across tasks.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
EuroQol Five-Dimension, Five-Level (EQ-5D-5L)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The tool measures quality of life and perceived health condition. Each of the five EQ-5D dimensions has five levels, generating a 5-digit code that represents the participant's health state (1=no problems up to 5=extreme problems). The EQ VAS provides a self-rated measure of overall health on a vertical scale ranging from 'the best' to 'the worst' health imaginable. The VAS can be used as a quantitative measure of health outcome.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
Goal Specific Hope Scale (GSHS)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The questionnaire iis used to measure hope for the goals set on COPM. . The GSHS contains 6 items divided equally into agency and pathways subscales. Respondents rate each item on a scale ranging from 1 (definitely false) to 8 (definitely true). An example agency item is, ''I energetically pursue this goal,'' and an example pathways item is, ''I can think of many ways to achieve this goal.'' Scores can range from 3 to 24 for the agency and pathways subscales and from 6 to 48 for total hope.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The Depression, Anxiety, and Stress Scale - 21 (DASS-21)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
A self-reporting instrument developed to assess emotional distress across three domains19: Depression, Anxiety, and Stress. A four-point Likert-type response format is used for scoring. A higher score indicates a greater distress.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The Self-Compassion Scale - Short Form (SCS-SF)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
A self-report instrument designed to measure individuals' tendencies to be kind and understanding toward themselves during difficult times, rather than self-critical or judgmental. Each item is rated on a 5-point Likert scale, ranging from 1 ("almost never") to 5 ("almost always"). Higher total scores reflect greater levels of self-compassion.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The cancer-related loneliness assessment tool (C-LAT)
時間枠：At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
The tool identifies and assess the qualities of cancer-related loneliness in adult cancer survivors who have completed treatment. Qualities that will be identified, their level of emotional distress it causes for the individual will be assessed. As loneliness is not a clinical condition for which specific diagnostic symptoms and cut-offs exist. For the study's purpose, we generated a score from 0 to 60, to indicate the severity of qualities' emotional distress level. A higher score indicates a severer emotional distress.
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

その他の成果指標

結果測定
メジャーの説明
時間枠
A demographic and medical questionnaire was developed and designed for the study to collect descriptive personal, demographic, and medical information.
時間枠：At baseline assessment
At baseline assessment
A questionnaire aimed at assessing their satisfaction with the CRAFT-G.
時間枠：Post intervention at week 6
The questionnaire was developed for the purposes of the study and includes questions about the components of the intervention, delivery format and relationship with group leader and members. A five-point scale (1="to a very little extent" to 5="to a very large extent").
Post intervention at week 6

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

Hadassah Medical Organization

協力者

Hebrew University of Jerusalem
Israel Cancer Association

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。

一般刊行物

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 (実際)

2025年11月16日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月18日

QC基準を満たした最後の更新が送信されました

2026年5月11日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • chenaitHMO

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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