RecruitingNot ApplicableNCT07591857

The Computerized Retraining and Functional Treatment - Group Intervention

The Computerized Retraining and Functional Treatment: Effectiveness-implementation Hybrid Trial of Group Teleintervention Among Breast Cancer Survivors With Cognitive Impairment


Sponsor

Hadassah Medical Organization

Enrollment

48 participants

Start Date

Nov 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria1

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

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Interventions

BEHAVIORALCRAFT-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.

OTHERCCT

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.


Locations(1)

Hadassah Medical Care

Jerusalem, Israel

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NCT07591857


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