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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CRAFT-G
BehavioralCRAFT-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.
CCT
Other interventionParticipants 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Cognitive Retraining and Functional Treatment Group (CRAFT-G) interventionExperimental treatment 1 intervention
Group B: Computerized cognitive training groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional Assessment of Cancer Therapy - Cognition (FACT COG)
A self-report questionnaire for cancer patients capturing subjective experiences of cognitive decline. The participants are asked to rate the items on a five-level scale ranging from 0="never" or "not at all" to 4="several times a day" or "very much;" higher scores represent better perceived cognitive function and QoL. Minimal clinically important difference (MCID) for the FACT-Cog was found to range from +4.7% to +7.2% for improvement (Liang et al., 2019), and -6.9 to -10.6 points for reduction.
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).2
The Canadian Occupational Performance Measure (COPM)
A semi-structured interview used to assess the self-perception of clients' performance and satisfaction with performance in individual functional goals. The goals are quantified by rating importance, performance, and satisfaction on a 10-point Likert scale. A higher score indicates a greater outcome. A two-point difference between measurements taken at different time points is considered the Minimal Clinically Important Difference (MCID).
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).3
The Performance Quality Rating Scale (PQRS)
The PQRS is used in conjunction with the COPM, to compliment the client's perceived performance with actual performance or client's self-report performance of the client-selected goal. The researcher or clinician rates the performance on a scale of 1 (the skill is not done well) to 10 (the skill is performed very well). A two-point difference between measurements taken at different time points is considered the Minimal Clinically Important Difference (MCID).
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).Secondary outcomes
1
Online cognitive assessment battery
Cognitive assessment will be conducted using the Effectivate online cognitive training platform, which includes four tasks assessing the following cognitive domains: (1) processing speed, (2) executive attention, (3) nonverbal visual memory and binding, and (4) declarative and working memory. Performance will be evaluated based on differences in mean response time and percentage of correct responses across tasks.
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).2
EuroQol Five-Dimension, Five-Level (EQ-5D-5L)
The tool measures quality of life and perceived health condition. Each of the five EQ-5D dimensions has five levels, generating a 5-digit code that represents the participant's health state (1=no problems up to 5=extreme problems). The EQ VAS provides a self-rated measure of overall health on a vertical scale ranging from 'the best' to 'the worst' health imaginable. The VAS can be used as a quantitative measure of health outcome.
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).3
Goal Specific Hope Scale (GSHS)
The questionnaire iis used to measure hope for the goals set on COPM. . The GSHS contains 6 items divided equally into agency and pathways subscales. Respondents rate each item on a scale ranging from 1 (definitely false) to 8 (definitely true). An example agency item is, ''I energetically pursue this goal,'' and an example pathways item is, ''I can think of many ways to achieve this goal.'' Scores can range from 3 to 24 for the agency and pathways subscales and from 6 to 48 for total hope.
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).4
The Depression, Anxiety, and Stress Scale - 21 (DASS-21)
A self-reporting instrument developed to assess emotional distress across three domains19: Depression, Anxiety, and Stress. A four-point Likert-type response format is used for scoring. A higher score indicates a greater distress.
Time frame
At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).Other outcomes
1
A demographic and medical questionnaire was developed and designed for the study to collect descriptive personal, demographic, and medical information.
Time frame
At baseline assessment2
A questionnaire aimed at assessing their satisfaction with the CRAFT-G.
The questionnaire was developed for the purposes of the study and includes questions about the components of the intervention, delivery format and relationship with group leader and members. A five-point scale (1="to a very little extent" to 5="to a very large extent").
Time frame
Post intervention at week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hadassah Medical Organization
Lead sponsor
Israel Cancer Association
Collaborator
Hebrew University of Jerusalem
Collaborator
Source ClinicalTrials.gov