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
Sponsors and collaborators
Hadassah Medical Organization
Lead sponsor
Israel Cancer Association
Collaborator
Hebrew University of Jerusalem
Collaborator