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

• ClinicalTrials.gov Identifier: NCT04829539
• Recruitment Status: Recruiting
• First Posted: April 2, 2021
• Last Update Posted: May 1, 2024
• Sponsor: University of Rochester NCORP Research Base
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Karen Mustian, University of Rochester NCORP Research Base

Tracking Information

• First Submitted Date: March 11, 2021
• First Posted Date: April 2, 2021
• Last Update Posted Date: May 1, 2024
• Actual Study Start Date: June 24, 2021
• Estimated Primary Completion Date: January 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2023)

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.

Original Primary Outcome Measures (submitted: April 1, 2021)

Mean change in the Insomnia Severity Index (ISI) total score [ Time Frame: Baseline to day 42 ]

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.

Current Secondary Outcome Measures (submitted: May 22, 2023)

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.

Original Secondary Outcome Measures (submitted: April 1, 2021)

Mean change in Sleep Efficiency assessed via Actigraphy [ Time Frame: Baseline to day 42 ]

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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
• Official Title: Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
• Brief 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.

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Intervention

• 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
• 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

Study Arms

• Experimental: Group I (BBT-CI)
  Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
  Interventions:

  • Behavioral: Behavioral Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
• Active Comparator: Group II (HEAL)
  Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
  Interventions:

  • Behavioral: Behavioral Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 1, 2021): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2027
• Estimated Primary Completion Date: January 30, 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Karen Mustian, University of Rochester NCORP Research Base
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Rochester NCORP Research Base
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Oxana Palesh; University of Rochester NCORP Research Base

• PRS Account: University of Rochester
• Verification Date: April 2024