An interventional study of CRAFT-G and CCT in Cancer Related Cognitive Impairment and Breast Cancer Survivor, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment
Among 12 studies in Breast Neoplasms by Hadassah Medical Organization — 2 open to participants now, 2 under way, none of them phase 3. Breast Neoplasms · Hadassah Medical Organization.
Among the 12 studies in Breast Neoplasms by Hadassah Medical Organization, this one is the only one that started in 2025, is one of 3 with no phase, and was the 12th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →2 of the 12 studies in Breast Neoplasms by Hadassah Medical Organization are open now, in 1 country. Recruiting first, the newest first:
Hadassah Medical Organization · Sites in Israel
Ages 18+
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 1
First in 2006; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 48 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 25 across the 7 interventional studies, 300 across the 5 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.
1 of the studies in Breast Neoplasms by Hadassah Medical Organization that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07591857Hadassah Medical OrganizationThe Computerized Retraining and Functional Treatment - Group Intervention | 2027-10 |
Among the 12 studies in Breast Neoplasms by Hadassah Medical Organization, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
The study will be conducted to explore implementation barriers and facilitators. This will be done by endline qualitative interviews with the participants' research group.
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.
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Exclusion Criteria:
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.
Behavioral: CRAFT-G
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.
Other: CCT
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.
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.
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).
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).
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).
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).
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).
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).
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).
The Self-Compassion Scale - Short Form (SCS-SF)
A self-report instrument designed to measure individuals' tendencies to be kind and understanding toward themselves during difficult times, rather than self-critical or judgmental. Each item is rated on a 5-point Likert scale, ranging from 1 ("almost never") to 5 ("almost always"). Higher total scores reflect greater levels of self-compassion.
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)
The tool identifies and assess the qualities of cancer-related loneliness in adult cancer survivors who have completed treatment. Qualities that will be identified, their level of emotional distress it causes for the individual will be assessed. As loneliness is not a clinical condition for which specific diagnostic symptoms and cut-offs exist. For the study's purpose, we generated a score from 0 to 60, to indicate the severity of qualities' emotional distress level. A higher score indicates a severer emotional distress.
Time frame: At baseline assessment and will be repeated post-intervention at week 6, and at follow-up (week 12).
A demographic and medical questionnaire was developed and designed for the study to collect descriptive personal, demographic, and medical information.
Time frame: At baseline assessment
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 6
Plan to share: Undecided
Started Nov 2025 (actual). Primary completion is estimated for Oct 2027, 23 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 23 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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