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Cancer Related Cognitive ImpairmentCRAFT-GNCT07591857

The Computerized Retraining and Functional Treatment - Group Intervention

A study testing CRAFT-G and CCT in people with Cancer Related Cognitive Impairment and Breast Cancer Survivor, run by Hadassah Medical Organization at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
CRAFT-G and CCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteIsrael
Study dates
16 Nov 2025to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chenanit Hamami contact

+972506373099

chenanit.hamami@mail.huji.ac.il

Israel1 site, 1 recruiting

  • Hadassah Medical Care

    Jerusalem

    Chenanit Hamami, Mrs., +972506373099, chenanit.hamami@mail.huji.ac.il

    Yafit Gilboa, Prof., yafit.gilboa@mail.huji.ac.il

    Recruiting

Other trials in Israel

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
CRAFT-G, CCT
Keywords
Tele-rehabilitation, Cognitive training, Group therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRAFT-GBehavioural

    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.

  • CCTOther

    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.

Study groups in NCT07591857
Study groupRoleWhat they receive
Cognitive Retraining and Functional Treatment Group (CRAFT-G) interventionExperimentalCRAFT-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.
Receives: Behavioral: CRAFT-G
Computerized cognitive training groupExperimentalParticipants 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.
Receives: Other: CCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Assessment of Cancer Therapy - Cognition (FACT COG)

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  2. The Canadian Occupational Performance Measure (COPM)

    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).

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  3. The Performance Quality Rating Scale (PQRS)

    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).

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

Secondary outcomes (6)

  1. Online cognitive assessment battery

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  2. EuroQol Five-Dimension, Five-Level (EQ-5D-5L)

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  3. Goal Specific Hope Scale (GSHS)

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  4. The Depression, Anxiety, and Stress Scale - 21 (DASS-21)

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  5. The Self-Compassion Scale - Short Form (SCS-SF)

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

  6. The cancer-related loneliness assessment tool (C-LAT)

    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.

    Measured: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start16 Nov 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07591857
Sponsor's protocol ID
chenaitHMO
Acronym
CRAFT-G
Status last verified
May 2026
First submitted
11 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Maeir T, Makranz C, Peretz T, Odem E, Tsabari S, Nahum M, Gilboa Y. Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Support Care Cancer. 2023 Feb 7;31(3):152. doi: 10.1007/s00520-023-07611-y.

    PubMed 36746805

Questions about this trial

What is this clinical trial studying?

A study testing CRAFT-G and CCT in people with Cancer Related Cognitive Impairment and Breast Cancer Survivor, run by Hadassah Medical Organization at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chenanit Hamami (+972506373099, chenanit.hamami@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Cancer Therapy - Cognition (FACT COG) (time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07591857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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