Metacognitive Strategy Training in Cancer-related Cognitive Impairment (NCT05505045) | Clinical Trial Compass
CompletedNot Applicable
Metacognitive Strategy Training in Cancer-related Cognitive Impairment
United States46 participantsStarted 2022-10-11
Plain-language summary
The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.
Who can participate
Age range
40 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score \>30)
* completed full course of chemotherapy at least 6 months, but no later than 3 years, prior to participation
* able to read, write, and speak English fluently
* able to provide valid informed consent
* have a life expectancy of greater than 6 months at time of enrollment
* diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and completed chemotherapy within the preceding three years
* on stable doses of medications (i.e., no changes in past 60 days)
Exclusion Criteria:
* prior cancer diagnoses of other sites with evidence of active disease within the past year
* active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury)
* severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Telehealth Usability Questionnaire (TUQ)
Timeframe: After study completion, an average of 14 weeks
2
Acceptability of Intervention Measure (AIM)
Timeframe: After study completion, an average of 14 weeks
3
Intervention Appropriateness Measure (IAM)
Timeframe: After study completion, an average of 14 weeks
4
Feasibility of Intervention Measure (FIM)
Timeframe: After study completion, an average of 14 weeks
5
Canadian Occupational Performance Measure (COPM) Trained Goal Performance
Timeframe: Pre-intervention (week 0) and post-intervention (week 14)
6
NeuroQoL Cognitive Function Short Form
Timeframe: Pre-intervention (week 0) and post-intervention (week 14)
7
Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction
Timeframe: After study completion, an average of 14 weeks