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

Recruiting at 133 trial locations

Overseen By Shari Ladd

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

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?

Research shows that Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is effective in improving sleep and quality of life in cancer patients, with studies indicating significant improvements in sleep efficiency and insomnia severity compared to healthy eating education controls. ^{1 2 3 4 5}

Is Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) safe for humans?

Research indicates that Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is generally safe for humans, as it has been tested in various studies with cancer patients and has shown to improve sleep and quality of life without significant safety concerns. ^{1 2 4 5 6}

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. ^{1 4 5 7 8}

Research Team

Oxana Palesh

Principal Investigator

University of Rochester NCORP Research Base

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.

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

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)
• 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.

Participant Groups

Group I: Group I (BBT-CI) Experimental Treatment 3 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 3 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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. [2021]

2. United States 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. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. [2021]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. [2020]

8. England pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]