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

University of Rochester NCORP Research Base

Status and phase: Enrolling; Phase 3

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Electronic Health Record Review; Other: Questionnaire Administration; Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04829539

UG1CA189961 (U.S. NIH Grant/Contract)

R01CA214647 (U.S. NIH Grant/Contract)

NCI-2020-07175 (Registry Identifier)

URCC19185 (Other Identifier)

R01CA239714 (U.S. NIH Grant/Contract)

URCC-19185 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups

Group I (BBT-CI)

Experimental group

Description:

Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

Treatment:

Behavioral: Behavioral Intervention

Other: Quality-of-Life Assessment

Behavioral: Behavioral Intervention

Other: Questionnaire Administration

Other: Electronic Health Record Review

Group II (HEAL)

Active Comparator group

Description:

Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

Treatment:

Behavioral: Behavioral Intervention

Other: Quality-of-Life Assessment

Behavioral: Behavioral Intervention

Other: Questionnaire Administration

Other: Electronic Health Record Review