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Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment

RECRUITINGPhase 3Sponsored by University of Rochester NCORP Research Base
Actively Recruiting
PhasePhase 3
SponsorUniversity of Rochester NCORP Research Base
Started2021-06-24
Est. completion2026-03-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations153 sites

Summary

This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Be at least 18 years of age
* Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
* Be currently receiving any cancer treatment (surgery alone is excluded)
* Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems"
* Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
* Be able to speak, understand and read English to participate in the study assessments and interventions

Exclusion Criteria:

* Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
* Be engaged in a formal cognitive behavioral therapy for insomnia program presently or in the past 30 days. Use of sleep medications are allowed

Conditions3

CancerHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Locations153 sites

Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact702-384-0013research@sncrf.org
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact800-378-9373
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact303-720-2685kristi.m.bronkan@kp.org
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Site Public Contact303-720-2685kristi.m.bronkan@kp.org
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124
Site Public Contact303-720-2685kristi.m.bronkan@kp.org

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