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

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ClinicalTrials.gov Identifier: NCT04829539
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : March 8, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Karen Mustian, University of Rochester NCORP Research Base

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Behavioral: Behavioral Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : January 30, 2027
Estimated Study Completion Date : June 30, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
 Behavioral: Behavioral Intervention
Receive BBT-CI
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
 Behavioral: Behavioral Intervention
Receive HEAL
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in the Insomnia Severity Index (ISI) total score [ Time Frame: Baseline to day 49 ]
    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.


Secondary Outcome Measures :
  1. Mean change in Sleep Efficiency assessed via Actigraphy [ Time Frame: Baseline to day 49 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829539


Locations
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Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Oxana Palesh University of Rochester NCORP Research Base
More Information
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Responsible Party: Karen Mustian, Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT04829539    
Other Study ID Numbers: URCC19185
NCI-2020-07175 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC19185 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-19185 ( Other Identifier: DCP )
URCC19185 ( Other Identifier: CTEP )
R01CA214647 ( U.S. NIH Grant/Contract )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms