The Computerized Retraining and Functional Treatment - Group Intervention (CRAFT-G)
11 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
48
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Chenanit Hamami
- Numero di telefono: +972506373099
- Email: chenanit.hamami@mail.huji.ac.il
Luoghi di studio
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Jerusalem, Israele
- Reclutamento
- Hadassah Medical Care
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Contatto:
- Chenanit Hamami, Mrs.
- Numero di telefono: +972506373099
- Email: chenanit.hamami@mail.huji.ac.il
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Contatto:
- Yafit Gilboa, Prof.
- Email: yafit.gilboa@mail.huji.ac.il
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Sub-investigatore:
- Chenanit Hamami
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Investigatore principale:
- Yafit Gilboa, Prof.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- women, 18 years old and older
- A subjective concern about declines in cognitive functioning related to a diagnosis of breast cancer and/or cancer related treatment
- Objective cognitive decline with no dementia (19<MOCA)
- 6 months or more after completion of an active treatment for cancer
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Cognition (FACT COG)
Lasso di tempo: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
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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).
|
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The Canadian Occupational Performance Measure (COPM)
Lasso di tempo: 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).
|
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The Performance Quality Rating Scale (PQRS)
Lasso di tempo: 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).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Online cognitive assessment battery
Lasso di tempo: 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.
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At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
|
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EuroQol Five-Dimension, Five-Level (EQ-5D-5L)
Lasso di tempo: 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.
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At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
|
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Goal Specific Hope Scale (GSHS)
Lasso di tempo: 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.
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At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
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The Depression, Anxiety, and Stress Scale - 21 (DASS-21)
Lasso di tempo: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
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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.
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At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
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The Self-Compassion Scale - Short Form (SCS-SF)
Lasso di tempo: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
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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).
|
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The cancer-related loneliness assessment tool (C-LAT)
Lasso di tempo: 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.
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At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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A demographic and medical questionnaire was developed and designed for the study to collect descriptive personal, demographic, and medical information.
Lasso di tempo: At baseline assessment
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At baseline assessment
|
|
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A questionnaire aimed at assessing their satisfaction with the CRAFT-G.
Lasso di tempo: 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").
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Post intervention at week 6
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Collaboratori e investigatori
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Sponsor
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Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 novembre 2025
Completamento primario (Stimato)
1 ottobre 2027
Completamento dello studio (Stimato)
1 giugno 2028
Date di iscrizione allo studio
Primo inviato
11 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 maggio 2026
Primo Inserito (Effettivo)
18 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- chenaitHMO
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INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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