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 range25 Years – 85 Years
SexFEMALE
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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;
✕. History of narcolepsy;
✕. Night shift work;
✕. Distant metastatic disease at presentation;
✕. Active alcohol and/or drug dependence;
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)