The Computerized Retraining and Functional Treatment - Group Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHadassah Medical Organization

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CRAFT-G
  • CCT

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hadassah Medical Organization

Lead sponsor

Israel Cancer Association

Collaborator

Hebrew University of Jerusalem

Collaborator