The Computerized Retraining and Functional Treatment - Group Intervention

NCT07591857 | Recruiting

• 1 other identifier: chenaitHMO
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Cancer Survivor; Cancer Related Cognitive Impairment

Keywords

Tele-rehabilitation; Cognitive training; Group therapy

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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).

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

• 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).

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

Secondary Outcomes (6)

• Online cognitive assessment battery

  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)

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

• Goal Specific Hope Scale (GSHS)

  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)

  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)

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

Other Outcomes (2)

• A demographic and medical questionnaire was developed and designed for the study to collect descriptive personal, demographic, and medical information.

  At baseline assessment

• A questionnaire aimed at assessing their satisfaction with the CRAFT-G.

  Post intervention at week 6

Study Arms (2)

Cognitive Retraining and Functional Treatment Group (CRAFT-G) intervention

EXPERIMENTAL

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.

Behavioral: CRAFT-G

Computerized cognitive training group

EXPERIMENTAL

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.

Other: CCT

Interventions

CRAFT-G BEHAVIORAL

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.

Cognitive Retraining and Functional Treatment Group (CRAFT-G) intervention

CCT OTHER

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.

Computerized cognitive training group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• months or more after completion of an active treatment for cancer
• Daily access to the internet and sufficient basic skills to operate a computer

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Israel Cancer Association: collaborator
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Hadassah Medical Care

Jerusalem, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 36746805 BACKGROUND

Central Study Contacts

Chenanit Hamami

CONTACT

+972506373099; chenanit.hamami@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: November 16, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IL (1)