The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients (NCT05226078) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
United States64 participantsStarted 2023-03-01
Plain-language summary
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.
Who can participate
Age range
25 Years – 85 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
. The diagnosis of organ-confined BC;
. Treatment with RT;
. Willingness and ability to provide informed consent;
. They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F;
. and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).
Exclusion criteria
. History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG;
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
Recruitment
Timeframe: Baseline to End of Treatment (Up to 12 weeks)
2
Adherence
Timeframe: Baseline to End of Treatment (Up to 12 weeks)
3
Treatment Acceptability
Timeframe: End of Treatment
4
Retention
Timeframe: Baseline to End of Treatment (Up to 12 weeks)