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

Recruiting at 177 trial locations

Overseen By Brooke Burgess, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Rochester NCORP Research Base

Disqualifiers: Obstructive sleep apnea, Restless leg syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which approach more effectively reduces insomnia in cancer patients: Brief Behavioral Therapy (BBT-CI) or Healthy Eating Education (HEAL). Insomnia, characterized by difficulty falling or staying asleep, is common during cancer treatment and can significantly impact daily life. Participants will attend sessions focused on either behavioral therapy or healthy eating habits. Those with cancer (stage I-IV), currently receiving treatment (beyond surgery), and experiencing sleep problems may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for insomnia in cancer patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is generally safe. Studies have found it practical and acceptable for patients with cancer-related sleep problems. Patients report that the therapy is easy to handle, with few side effects.

Healthy Eating Education Learning (HEAL) focuses on teaching better eating habits and has not been associated with harm. No specific evidence of safety issues exists with this approach, and it is considered safe for most people.

Both BBT-CI and HEAL are non-drug treatments, which usually result in fewer side effects compared to medication. Overall, both treatments are considered safe and may help improve sleep for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for cancer-related insomnia because they offer non-drug approaches that focus on behavioral changes and lifestyle improvements. Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is unique because it helps patients alter their sleep habits through structured sessions, which could lead to quicker and more sustainable sleep improvements without medication side effects. On the other hand, Healthy Eating Education Learning (HEAL) aims to improve sleep by teaching patients how dietary choices can impact insomnia, offering a holistic approach that integrates nutrition with sleep health. These methods stand out from traditional treatments like medications or basic sleep hygiene education by addressing the root behavioral and lifestyle contributors to insomnia.

What evidence suggests that this trial's treatments could be effective for reducing insomnia in cancer patients?

Research has shown that Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), a treatment in this trial, can reduce sleep problems in cancer patients. One study found that patients receiving BBT-CI slept better than those receiving other treatments. Another study demonstrated that BBT-CI was more effective at easing insomnia symptoms than the Healthy Eating Education Learning (HEAL) approach, another treatment option in this trial, with patients experiencing improved sleep after the therapy. These findings suggest that BBT-CI could effectively manage sleep issues caused by cancer treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Oxana Palesh, PhD

Principal Investigator

Massey Cancer Center

Are You a Good Fit for This Trial?

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.

You have a sleep problem that is severe, as measured by the Insomnia Severity Index score of 10 or higher.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Therapy (BBT-CI)
• Healthy Eating Education Learning (HEAL)

Trial Overview 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.

How Is the Trial Designed?

Group I: Group I (BBT-CI) Experimental Treatment 4 Interventions

Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

Group II: Group II (HEAL) Active Control 4 Interventions

Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials

14

Recruited

9,100+

Massey Cancer Center

Collaborator

Trials

10

Recruited

600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A phase II randomized controlled trial involving 71 breast cancer patients showed that brief behavioral therapy for cancer-related insomnia (BBT-CI) is both feasible and acceptable, with trained community staff successfully delivering 72% of the intervention components.

Patients receiving BBT-CI experienced a significant improvement in insomnia severity (6.3 points) and circadian rhythm compared to those in the Healthy Eating Education Learning control group, who only improved by 2.5 points (P=0.041), indicating BBT-CI's effectiveness in managing insomnia during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Palesh, O., Scheiber, C., Kesler, S., et al.[2023]

In a pilot study involving 74 breast cancer patients undergoing chemotherapy, Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) significantly improved insomnia symptoms compared to a sleep hygiene pamphlet control.

The effectiveness of BBT-CI was particularly pronounced in patients with lower anxiety levels, those who had undergone previous cancer surgeries, and those with higher baseline symptom severity, suggesting that certain patient characteristics may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy : A pilot study. Palesh, O., Solomon, N., Hofmeister, E., et al.[2021]

A secondary analysis of a pilot trial involving 71 breast cancer patients showed that Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) significantly improved quality of life (QOL) and heart rate variability (HRV) compared to a healthy-eating control intervention over 6 weeks.

Patients receiving BBT-CI experienced notable enhancements in QOL scores and HRV measures, indicating that this therapy could be beneficial for managing insomnia in cancer patients when delivered in community oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial. Palesh, O., Scheiber, C., Kesler, S., et al.[2020]

This study aims to evaluate the effectiveness of Brief Behavioral Therapy for Insomnia (BBTI) in reducing insomnia among 158 cancer survivors, marking the first time this approach is tested in such a diverse group.

The primary outcome will be assessed using the Insomnia Severity Index (ISI), with follow-up assessments planned at 1, 3, and 12 months to determine the durability of the intervention's effects on sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Kwon, M., Dickerson, SS., Wilding, GE., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

In a pilot study involving 21 breast cancer survivors, individual cognitive behavioral therapy for insomnia (IND-CBT-I) significantly improved self-rated insomnia and sleep quality compared to a delayed treatment control group.

The results suggest that IND-CBT-I is a practical and effective option for improving sleep in breast cancer survivors, making it accessible in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Fiorentino, L., McQuaid, JR., Liu, L., et al.[2021]

The Brief Behavioral Treatment for Insomnia (BBTI) significantly improved sleep efficiency in lung cancer survivors, with over 85% of participants showing improvement, compared to no change in the Healthy Eating Program (HEP) control group.

BBTI also enhanced the quality of life, as indicated by a significant increase in the FACT-L score, while the HEP group experienced a decline, highlighting BBTI's potential as an effective intervention for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. Dean, GE., Weiss, C., Jungquist, CR., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment for insomnia in breast cancer survivors, significantly improving sleep quality, mood, and overall quality of life based on a review of 16 studies.

The benefits of CBT-I, including reductions in fatigue and menopausal symptoms, are durable, lasting up to 12 months after treatment, highlighting its potential as a long-term solution for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. Aricò, D., Raggi, A., Ferri, R.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39589721/

Nurse-delivered brief behavioral treatment for insomnia in ... The BBTI group was significantly effective in reducing insomnia severity and improving sleep quality over time compared to the control among cancer survivors.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.10094

RCT of brief behavioral therapy (BBT-CI) for cancer-related ... ANCOVA results indicate that patients who received BBT-CI exhibited improvements in insomnia compared to HEAL at post-intervention (p = .049) ...

3. nature.com nature.com/articles/s41416-018-0154-2

Feasibility and acceptability of brief behavioral therapy for ... This phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7755138/

A novel approach to management of sleep-associated ... This pilot randomized controlled trial (RCT) was conducted to assess the preliminary effects of Brief Behavioral Therapy for Cancer-Related Insomnia ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725000723

Web-based cognitive-behavioral therapy for insomnia in ... Our results indicate that, in cancer survivors, web-based CBT-I appears to be effective in reducing insomnia severity and improving daytime functioning and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04829539

Comparing Brief Behavioral Therapy (BBT-CI) and Healthy ... 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.

7. asco.org asco.org/abstracts-presentations/ABSTRACT184689

RCT of brief behavioral therapy (BBT-CI) for cancer-related ... Background: Insomnia is experienced by up to 80% of cancer patients, and it frequently co-occurs with circadian rhythm disruption.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6068121/

Feasibility and acceptability of brief behavioral therapy for ... This phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03810365

Brief Behavioral Treatment for Insomnia in Cancer Survivors A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6892630/

Secondary Outcomes of a Behavioral Sleep Intervention The aim of this secondary analysis was to evaluate the possible effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), delivered during ...