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

Last updated: August 12, 2024
Sponsor: University of Rochester NCORP Research Base
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasms

Treatment

Behavioral Intervention

Quality-of-Life Assessment

Questionnaire Administration

Clinical Study ID

NCT04829539
URCC19185
URCC19185
URCC-19185
UG1CA189961
R01CA214647
NCI-2020-07175
R01CA239714
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Be at least 18 years of age

  • Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of atleast 12 months

  • Be currently receiving any cancer treatment (surgery alone is excluded)

  • Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rateyour sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problemsand 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 studyassessments and interventions

Exclusion

Exclusion Criteria:

  • Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (evenif controlled)

  • Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presentlyor in the past 30 days. Use of psychotropics and sleep medication are allowed

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Behavioral Intervention
Phase: 3
Study Start date:
June 24, 2021
Estimated Completion Date:
June 30, 2027

Study 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.

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    Wilkes-Barre, Pennsylvania 18711
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    Charleston, South Carolina 29406
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    Charleston, South Carolina 29414
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  • Roper Hospital

    Charleston, South Carolina 29401
    United States

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  • Lowcountry Hematology Oncology PA-Mount Pleasant

    Mount Pleasant, South Carolina 29464
    United States

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  • Chesapeake Regional Medical Center

    Chesapeake, Virginia 23320
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  • Hematology Oncology Associates of Fredericksburg Inc

    Fredericksburg, Virginia 22408
    United States

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  • Centra Lynchburg Hematology-Oncology Clinic Inc

    Lynchburg, Virginia 24501
    United States

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  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia 23235
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  • Virginia Cancer Institute

    Richmond, Virginia 23230
    United States

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  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

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  • VCU Community Memorial Health Center

    South Hill, Virginia 23970
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  • Shenandoah Oncology PC

    Winchester, Virginia 22601
    United States

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  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington 98225
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  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin 54911
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  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin 54701
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  • Cancer Research of Wisconsin and Northern Michigan Consortium

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