Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivor | — | UNRESOLVED | — |
| Cancer Related Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCT | Other | — | UNRESOLVED |
| CRAFT-G | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive Retraining and Functional Treatment Group (CRAFT-G) intervention
- description
- 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.
- interventionNames
- Behavioral: CRAFT-G
- type
- EXPERIMENTAL
- label
- Computerized cognitive training group
- description
- 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.
- interventionNames
- Other: CCT
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDMaeir T, Makranz C, Peretz T, Odem E, Tsabari S, Nahum M, Gilboa Y. Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Support Care Cancer. 2023 Feb 7;31(3):152. doi: 10.1007/s00520-023-07611-y. PMID 36746805