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

11. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

48

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Experimentální: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional Assessment of Cancer Therapy - Cognition (FACT COG)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Online cognitive assessment battery
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
A demographic and medical questionnaire was developed and designed for the study to collect descriptive personal, demographic, and medical information.
Časové okno: At baseline assessment
At baseline assessment
A questionnaire aimed at assessing their satisfaction with the CRAFT-G.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hadassah Medical Organization

Spolupracovníci

Hebrew University of Jerusalem
Israel Cancer Association

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. listopadu 2025

Primární dokončení (Odhadovaný)

1. října 2027

Dokončení studie (Odhadovaný)

1. června 2028

Termíny zápisu do studia

První předloženo

11. května 2026

První předloženo, které splnilo kritéria kontroly kvality

11. května 2026

První zveřejněno (Aktuální)

18. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

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