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Behavioral Therapy vs. Healthy Eating Education for Cancer-Related Insomnia
Study Summary
This trial compares two treatments for insomnia in cancer patients receiving chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896Trial Design
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Who is running the clinical trial?
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- I am fully active or have some limitations but can take care of myself.I am currently in or have recently completed a program for insomnia.I am 18 years old or older.You have a sleep problem that is severe, as measured by the Insomnia Severity Index score of 10 or higher.I have been diagnosed with obstructive sleep apnea or restless leg syndrome.I am currently on chemotherapy, which may include biologics or antibodies.I have cancer and am expected to live for at least another year.I am currently undergoing cancer treatment, not including surgery alone.I have been experiencing sleep problems, rating 3 or higher in the last 2 weeks.My cancer is at stage I, II, or III.I can care for myself and am up and about more than half of my waking hours.
- Group 1: Group II (HEAL)
- Group 2: Group I (BBT-CI)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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