The Computerized Retraining and Functional Treatment - Group Intervention

Official title

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

Overview

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.

Detailed description

Breast cancer survivors are at risk of cancer-related cognitive impairment (CRCI), impacting their daily lives and well-being currently without satisfactory solutions. In our previous research, we developed Cognitive Retraining and Functional Treatment (CRAFT), combining computerized cognitive training with personalized approach which target daily functioning. We confirmed CRAFT's feasibility and effectiveness for CRCI through a large control trial, improving perceived cognition, cognitive performance, and daily life participation. Mental health challenges and limited access to rehabilitation programs further complicate post-breast cancer care. To address these issues, we propose a telemedicine approach that combines individualized CRAFT with group therapy (CRAFT-G) providing patients with peer-support, interpersonal learning, socialization, and normalization of their experience. CRAFT-G includes six remote group sessions led by an occupational therapist, focusing on goal setting and plan development. The content of the meetings will be adapted from the cognitive orientation to occupational performance (CO-OP) approach accompanied with relevant psychoeducation materials. In addition, participants engage in weekly cognitive training using dedicated app. Following a successful pilot study, we propose a two-step trial: the first step involves testing treatment efficacy and endurance in 48 patients (4 groups, n=24 control group), while the second step involves qualitative interviews with participants to identify barriers and facilitators to clinical implementation. The use of a novel, remotely applied group format intervention further extends the reach of care from the clinical setting to the home setting, providing a feasible and cost-effective treatment option that helps bridge the current therapeutic gaps for BCS experiencing CRCI. Our study aligns with cancer care recommendations by examining intervention effectiveness and implementation strategies and suggest a pragmatic intervention ready to be in real-world setting.

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
• 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 outcome measures

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

Secondary outcome measures (6)

• Online cognitive assessment battery [Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).]
• EuroQol Five-Dimension, Five-Level (EQ-5D-5L) [Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).]
• Goal Specific Hope Scale (GSHS) [Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).]
• The Depression, Anxiety, and Stress Scale - 21 (DASS-21) [Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).]
• The Self-Compassion Scale - Short Form (SCS-SF) [Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).]
• The cancer-related loneliness assessment tool (C-LAT) [Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).]

Eligibility criteria

Inclusion criteria

• 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Israel · 1 center

• Hadassah Medical Care — Jerusalem

Publications

• Maeir 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

Identifiers

NCT: NCT07591857 · chenaitHMO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗