Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Спонсор: University of Rochester NCORP Research Base
Налично на:
БГ
Обобщение
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.
Описание
PRIMARY OBJECTIVE:
I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention.
SECONDARY OBJECTIVE:
I. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at post-intervention.
MECHANISTIC OBJECTIVE:
I. Examine the efficacy of BBT-CI compared to HEAL for regulating circadian rhythms as measured via actigraphy (i.e., Mesor, Acrophase, Amplitude, I\<O dichotomy index).
EXPLORATORY OBJECTIVES:
I. Examine potential moderators of BBT-CI effects on insomnia (ISI). II. Examine potential mediators of BBT-CI effects on insomnia (ISI). III. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index at the 6-month follow-up.
IV. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at the 6-month follow-up.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (BBT-CI): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
GROUP II (HEAL): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
After completion of study, patients are followed for up to 6 months.
Кой може да участва
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
Интервенции
Behavioral Intervention
BEHAVIORAL
Behavioral Intervention
BEHAVIORAL
Electronic Health Record Review
OTHER
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Места на провеждане
153
САЩ (153)
Hawaii Cancer Care - Westridge
‘Aiea , Hawaii
Pali Momi Medical Center
‘Aiea , Hawaii
The Cancer Center of Hawaii-Pali Momi
‘Aiea , Hawaii
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny , Iowa
ThedaCare Regional Cancer Center
Appleton , Wisconsin
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin , Missouri
Bronson Battle Creek
Battle Creek , Michigan
PeaceHealth Saint Joseph Medical Center
Bellingham , Washington
Strecker Cancer Center-Belpre
Belpre , Ohio
Illinois CancerCare-Bloomington
Bloomington , Illinois
Minnesota Oncology - Burnsville
Burnsville , Minnesota
Illinois CancerCare-Canton
Canton , Illinois
Memorial Hospital of Carbondale
Carbondale , Illinois
SIH Cancer Institute
Carterville , Illinois
Illinois CancerCare-Carthage
Carthage , Illinois
Waverly Hematology Oncology
Cary , North Carolina
Physicians' Clinic of Iowa PC
Cedar Rapids , Iowa
Centralia Oncology Clinic
Centralia , Illinois
Christiana Care Health System-Concord Health Center
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EN