Sleep Programs for Cancer Patients

Overseen By Youngmee Kim, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Major depressive disorder, Psychosis, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Brief Behavioral Treatment for Insomnia (BBTI) for cancer patients?

Research shows that BBTI, a simplified version of cognitive behavioral therapy for insomnia, improved sleep efficiency and quality of life in lung cancer survivors. It has also been effective in reducing insomnia symptoms in other groups, like veterans, by providing practical skills and overcoming barriers to treatment. ^{1 2 3 4 5}

Is Brief Behavioral Treatment for Insomnia (BBTI) safe for humans?

BBTI has been studied in various groups, including lung cancer survivors and veterans, and no safety concerns have been reported in these studies. It is generally considered a safe treatment for improving sleep and quality of life. ^{1 2 3 4 6}

How is the treatment Brief Behavioral Treatment for Insomnia (BBTI) unique for cancer patients with sleep issues?

BBTI is a streamlined version of cognitive behavioral therapy for insomnia (CBTI) that can be delivered by nurses, making it more accessible and practical for cancer patients. It focuses on improving sleep efficiency and quality of life with fewer sessions, overcoming barriers like treatment length and limited availability of trained psychologists. ^{1 2 4 6 7}

Research Team

Youngmee Kim, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for pairs consisting of a cancer patient and their sleep-partner caregiver. They will participate together as a unit to explore sleep behaviors and test interventions aimed at improving sleep.

Inclusion Criteria

Patients having a consistent sleep partner

Caregivers being sleep partners of the patient

My caregiver and I are willing to change our poor sleep habits.

Exclusion Criteria

I have a history of major depression, psychosis, or bipolar disorder that is not being treated.

Patients and caregivers having active suicidality, or substance or alcohol dependency in the past year

Patients and caregivers having an extreme chronotype, or do shift work to have no overlap in sleep schedule between them

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Brief Behavioral Treatment for Insomnia (BBTI) or the My Sleep Our Sleep (MSOS) intervention

4 weeks

Follow-up

Participants are monitored for changes in sleep disturbance symptoms using the Pittsburgh Sleep Quality Index (PSQI)

4 weeks

Treatment Details

Interventions

• Brief Behavioral Treatment for Insomnia (BBTI)
• My Sleep Our Sleep (MSOS)

Trial Overview The study is testing two different programs: 'My Sleep Our Sleep' (MSOS) and 'Brief Behavioral Treatment for Insomnia' (BBTI). These are designed to help improve the quality of sleep for both patients with cancer and their partners.

Participant Groups

Group I: Phase 2 MSOS Intervention Group Experimental Treatment 1 Intervention

Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 4 weeks.

Group II: Phase 2 BBTI Intervention Group Experimental Treatment 1 Intervention

Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 4 weeks.

Brief Behavioral Treatment for Insomnia (BBTI) is already approved in United States for the following indications:

Approved in United States as BBTI for:

• Insomnia
• Insomnia comorbid with psychiatric, medical, or sleep disorders
• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Community Foundation for Brevard

Collaborator

Trials

1

Recruited

40+

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]

The Brief Behavioral Treatment for Insomnia (BBTI) was effective in helping veterans with insomnia develop skills for independent improvement, as reported by 46 veterans who participated in qualitative interviews after treatment.

Veterans appreciated the initial in-person sessions and the accountability provided by BBTI, but suggested improvements such as better personalization and clearer expectations for phone sessions to enhance the treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Barriers to Behavioral Treatments for Insomnia: A Qualitative Examination of Veterans' Perspectives of BBTI. Holder, N., Kanady, JC., Straus, LD., et al.[2022]

A brief behavioral treatment for insomnia (BBTI) was tested against cognitive behavioral therapy for insomnia (CBTI) in a study involving 63 veterans, showing that both treatments significantly reduced insomnia severity, but BBTI's effectiveness was inconclusive compared to CBTI.

While CBTI showed a greater reduction in insomnia severity, the difference was not statistically significant enough to declare BBTI inferior, suggesting that BBTI could be a viable alternative for veterans seeking shorter treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Bramoweth, AD., Lederer, LG., Youk, AO., et al.[2023]

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

Brief Behavioral Treatment for Insomnia (BBTI) is a concise, four-session therapy designed to overcome barriers to accessing traditional cognitive-behavioral therapy for insomnia (CBTI), making it easier for clinicians to deliver.

BBTI has shown efficacy in treating older adults with insomnia, providing a practical alternative to standard CBTI, which is limited by a shortage of trained clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of insomnia with brief behavioral treatment (BBTI). Troxel, WM., Germain, A., Buysse, DJ.[2022]

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Reducing Barriers to Behavioral Treatments for Insomnia: A Qualitative Examination of Veterans' Perspectives of BBTI. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. [2023]

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

Brief Behavioral Treatment of Insomnia. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Clinical management of insomnia with brief behavioral treatment (BBTI). [2022]

6. 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]

7. 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]