Behavioral Therapy vs. Healthy Eating Education for Cancer-Related Insomnia
Recruiting in Palo Alto (17 mi)
+133 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Rochester NCORP Research Base
Disqualifiers: Obstructive sleep apnea, Restless leg syndrome, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. In fact, the use of psychotropics and sleep medication is allowed.
What data supports the effectiveness of the treatment Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) for cancer-related insomnia?
Is Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) safe for humans?
How is the treatment for cancer-related insomnia different from other treatments?
The treatment, Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), is unique because it is a short, nurse-delivered therapy that focuses on changing sleep habits and behaviors, making it more accessible than traditional cognitive behavioral therapy, which often requires longer sessions with specialized psychologists.14578
Eligibility Criteria
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.Inclusion Criteria
Be able to speak, understand and read English to participate in the study assessments and interventions
I am fully active or have some limitations but can take care of myself.
I am 18 years old or older.
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Exclusion Criteria
I am currently in or have recently completed a program for insomnia.
I have been diagnosed with obstructive sleep apnea or restless leg syndrome.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) or Healthy Eating Education Learning (HEAL) through face-to-face/video and phone sessions
7 weeks
Multiple face-to-face/video and phone sessions
Follow-up
Participants are monitored for insomnia severity and sleep efficiency for up to 6 months after treatment
6 months
Treatment Details
Interventions
- Brief Behavioral Therapy (BBT-CI) (Behavioral Intervention)
- Healthy Eating Education Learning (HEAL) (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kingman Regional Medical CenterKingman, AZ
Illinois CancerCare-PekinPekin, IL
Metro Minnesota Community Oncology Research ConsortiumMinneapolis, MN
Comprehensive Cancer Centers of Nevada - HendersonHenderson, NV
More Trial Locations
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Who Is Running the Clinical Trial?
University of Rochester NCORP Research BaseLead Sponsor
Massey Cancer CenterCollaborator
National Cancer Institute (NCI)Collaborator
References
Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. [2021]Objective/Background: Insomnia occurs in 50 to 80% of lung cancer survivors. Cognitive behavioral therapy is the standard treatment for insomnia (CBTI); however, treatment length and lack of psychologists trained in CBTI limits access. Brief Behavioral Treatment for Insomnia (BBTI), a nurse-delivered modified CBTI, is proposed. This feasibility pilot study sought to compare the BBTI intervention to attention control Healthy Eating Program (HEP) for insomnia in lung cancer survivors. Participants: The participants comprised adults, 21 years of age or older with insomnia and stage I/II non-small cell lung cancer, more than 6 weeks from surgery and living in Western NY. Methods: Participants (n = 40) were randomly assigned to an experimental (BBTI) or attention control condition (Healthy Eating Program). Thirty participants completed the study. Results: Participants were 66 years of age (± 7.6; range 53-82), 40% (n = 16) male, 87.5% (n = 35) Caucasian, 50% (n = 20) married, BMI 27.7 (± 5.8), and 12% (n = 5) never smokers. Baseline sleep diary sleep efficiency, ISI and other baseline covariates were balanced between the groups. Sleep efficiency improved ≥85% in BBTI group (p = .02), but not in HEP control group (p = 1.00). Mean ISI for BBTI and attention control were 6.40 ± 4.98 and 14.10 ± 4.48 (p = .001) respectively. In addition, BBTI group mean total FACT-L score improved by 6.66 points from baseline while HEP group score worsened (p = .049). Conclusions: BBTI is a practical, evidence-based, clinically relevant intervention that improved sleep and quality of life in lung cancer survivors with insomnia. Additional research to evaluate efficacy, duration, and implementation strategies are essential.
A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy : A pilot study. [2021]This pilot randomized controlled trial (RCT) was conducted to assess the preliminary effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) delivered by trained research staff in comparison to a sleep hygiene pamphlet control and to assess moderators of treatment effect in patients with breast cancer undergoing chemotherapy.
Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. [2021]Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I) on sleep in breast cancer survivors.
Feasibility and acceptability of brief behavioral therapy for cancer-related insomnia: effects on insomnia and circadian rhythm during chemotherapy: a phase II randomised multicentre controlled trial. [2023]This phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia (BBT-CI) in breast cancer patients undergoing chemotherapy. We also assessed the preliminary effects of BBT-CI on insomnia and circadian rhythm in comparison to a Healthy Eating Education Learning control condition (HEAL).
A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. [2023]Insomnia has been frequently reported as one of the most burdensome symptoms among cancer survivors. To date, little research exists on strategies to effectively reduce insomnia in cancer survivors, especially in the application of cognitive behavioral therapy for insomnia (CBTI) at the bedside by nurses. The current objective is to determine efficacy and durability of a streamlined, individually delivered version of CBTI, specifically Brief Behavioral Therapy for Insomnia (BBTI) versus a healthy eating attention control, using a large heterogeneous sample of 158 cancer survivors. Study participants will be adults ≥18 years of age; ≥1 month from treatment (except hormones and targeted therapies are acceptable) for stages I through III breast, colorectal, lung or prostate cancers; meet criteria for insomnia defined by Insomnia Severity Index (ISI) >7; screen negative for obstructive sleep apnea
Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial. [2020]Nearly 80% of cancer patients struggle with insomnia, which is associated with decreased heart rate variability (HRV) and quality of life (QOL). The aim of this secondary analysis was to evaluate the possible effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), delivered during chemotherapy visits, on QOL and HRV in patients with breast cancer (BC).
Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. [2020]Insomnia is a common sleep disorder in patients with breast cancer and studies show a higher frequency than in the general population but it appears to be understudied and the treatment seems to be a neglected problem. There is a growing body of evidence about the efficacy of cognitive behavioral therapy for insomnia (CBT-I) in breast cancer survivors (BCS). The aim of this review is to examine the best available scientific evidence related to CBT-I and insomnia in patients with breast cancer and to assess the effect of CBT-I on their psychosocial functioning, sleep, quality of life, and mood.
A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]Cognitive-behavioral therapy for insomnia (CBT-Insomnia) is effective, yet rarely available for cancer survivors. This is unfortunate because survivors are at elevated risk for insomnia, which is associated with significant health consequences in this already at-risk population. Barriers to delivering CBT-Insomnia in oncology settings include a lack of trained providers, distance to cancer centers, and treatment duration.