NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Active Not RecruitingNA

Sponsor: Abramson Cancer Center at Penn Medicine

Conditions: Chronic Insomnia, Cancer-related Problem/Condition, Cancer-Related Syndrome

Interventions: Cognitive Behavioral Therapy for Insomnia

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 25 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. The diagnosis of organ-confined BC;
2. Treatment with RT;
3. Willingness and ability to provide informed consent;
4. 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;
5. and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).

Exclusion Criteria:

1. History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG;
2. History of narcolepsy;
3. Night shift work;
4. Distant metastatic disease at presentation;
5. Active alcohol and/or drug dependence;
6. They do not have a diagnosis of BC;
7. They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
8. They have a current diagnosis of significant medical and/or psychiatric disorders;
9. And/or they are not between the ages of 25-85 years.

Locations (1)

Philadelphia, Pennsylvania, United States