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

Study Overview
=================
Brief Summary
-----------------
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-III cancer who are receiving chemotherapy. Chemotherapy 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.

Detailed Description
-----------------
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 OBJECTIVES: 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.

Official Title
-----------------
Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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 psychotropics and sleep medication are allowed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (BBT-CI)<br>Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. | Behavioral: Behavioral Intervention<br>* Receive BBT-CI<br>* Other names: Behavioral Treatments;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (HEAL)<br>Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. | Behavioral: Behavioral Intervention<br>* Receive HEAL<br>* Other names: Behavioral Treatments;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the Insomnia Severity Index (ISI) total score | The Insomnia Severity Index (ISI) is a validated self-report measure of insomnia. A 5-point Likert Scale of seven questions is used to rate each item (0=no problem; 4=very severe problem), yielding a total score ranging from 0-28 with higher scores indicating higher severity of insomnia. A linear mixed effects analysis of covariance model (ANCOVA) will be used to assess the statistical significance of the differences in mean change between BBT-CI and HEAL. | Baseline to day 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Sleep Efficiency assessed via Actigraphy | Actigraphy will assess sleep efficiency, calculated as the percent of total sleep time to time in bed. Higher percentage indicates better sleep efficiency. A linear mixed effects analysis of covariance model (ANCOVA) will be used to assess the statistical significance of the differences in mean change between BBT-CI and HEAL. | Baseline to day 49 |