Recruiting

The Computerized Retraining and Functional Treatment - Group Intervention

ClinicalTrials.gov IDNCT07591857

PhaseNA

Enrollment48

SponsorHadassah Medical Organization

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Cancer Related Cognitive Impairment, Breast Cancer Survivor

About this study

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.

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.

Primary outcomes

Functional Assessment of Cancer Therapy - Cognition (FACT COG) (At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).)
The Canadian Occupational Performance Measure (COPM) (At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).)
The Performance Quality Rating Scale (PQRS) (At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).)

Eligibility information

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.

Study locations

Hadassah Medical Care, Jerusalem, Israel

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.