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The Computerized Retraining and Functional Treatment - Group Intervention

NCT07591857 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-18

No results posted yet for this study

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

  • Cancer Related Cognitive Impairment
  • Breast Cancer Survivor

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

  • Israel Cancer Association

    collaborator OTHER

  • Hebrew University of Jerusalem

    collaborator OTHER

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-16
Primary Completion
2027-10-31
Completion
2028-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591857 on ClinicalTrials.gov