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Behavioral Therapy vs. Healthy Eating Education for Cancer-Related Insomnia

Phase 3
Recruiting
Led By Oxana Palesh
Research Sponsored by University of Rochester NCORP Research Base
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
Be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 49
Awards & highlights

Study Summary

This trial compares two treatments for insomnia in cancer patients receiving chemotherapy.

Who is the study for?
This trial is for adults over 18 with stage I-III cancer experiencing sleep problems during chemotherapy. Participants must be able to speak English and have a life expectancy of at least 12 months. They should not have obstructive sleep apnea, restless leg syndrome, or current/former engagement in Cognitive Behavioral Therapy for Insomnia.Check my eligibility
What is being tested?
The study compares Brief Behavioral Therapy (BBT-CI) against Healthy Eating Education Learning (HEAL) to see which better reduces insomnia in cancer patients undergoing chemotherapy. It's designed to improve understanding of how these interventions can enhance sleep quality and overall well-being.See study design
What are the potential side effects?
Since the interventions involve behavioral therapy and education rather than medication, side effects are minimal but may include discomfort from discussing personal issues or changes in eating habits due to HEAL.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or have some limitations but can take care of myself.
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I am 18 years old or older.
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I am currently on chemotherapy, which may include biologics or antibodies.
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I have cancer and am expected to live for at least another year.
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I am currently undergoing cancer treatment, not including surgery alone.
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I have been experiencing sleep problems, rating 3 or higher in the last 2 weeks.
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My cancer is at stage I, II, or III.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 49
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 49 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in the Insomnia Severity Index (ISI) total score
Secondary outcome measures
Mean change in Sleep Efficiency assessed via Actigraphy

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896
13%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Behavioral Intervention & DCS
Behavioral Intervention & Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (BBT-CI)Experimental Treatment3 Interventions
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
Group II: Group II (HEAL)Active Control3 Interventions
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740

Find a Location

Who is running the clinical trial?

Massey Cancer CenterOTHER
9 Previous Clinical Trials
202 Total Patients Enrolled
1 Trials studying Blood Cancers
44 Patients Enrolled for Blood Cancers
University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
8,692 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,481 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers

Media Library

Brief Behavioral Therapy (BBT-CI) Clinical Trial Eligibility Overview. Trial Name: NCT04829539 — Phase 3
Blood Cancers Research Study Groups: Group II (HEAL), Group I (BBT-CI)
Blood Cancers Clinical Trial 2023: Brief Behavioral Therapy (BBT-CI) Highlights & Side Effects. Trial Name: NCT04829539 — Phase 3
Brief Behavioral Therapy (BBT-CI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04829539 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there different branches where this research is being conducted?

"So far, four centres are up-and-running for this clinical trial. For example, in Minneapolis there is the Metro-Minnesota Ncorp, and in Ann Arbor the Michigan Cancer Research Consortium. Additionally, in Green Bay there is the Saint Vincent Hospital, with other centres in four other locations."

Answered by AI

Are there any remaining open slots for volunteers in this clinical trial?

"That is correct, the information on clinicaltrials.gov does state that this clinical trial is actively recruiting candidates. The trial was first posted on 6/24/2021 and was most recently edited on 5/17/2022. The study is enrolling 400 participants at 4 locations."

Answered by AI

How many people are allowed to be a part of this test group?

"That is accurate. The clinical trial's page on clinicaltrials.gov shows that it is still looking for 400 individuals to enroll from 4 different locations. The trial was created on 6/24/2021 and was last updated on 5/17/2022."

Answered by AI

Does Behavioral Intervention have any negative side effects?

"Given that this is a Phase 3 trial, there is some evidence of efficacy and multiple rounds of data supporting safety, we rate the safety of Behavioral Intervention as a 3."

Answered by AI
~197 spots leftby Jan 2027