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

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore sleep behaviors and test new treatments for better sleep among cancer patients and their sleep partners. Researchers are testing two treatments: Brief Behavioral Treatment for Insomnia (BBTI) and My Sleep Our Sleep (MSOS), each lasting up to four weeks. They seek participants recently diagnosed with a solid tumor who have a consistent sleep partner. Participants should be open to changing poor sleep habits and reside in Brevard County, Florida. As an unphased trial, this study offers a unique opportunity to contribute to innovative sleep solutions for cancer patients.

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.

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

A previous study demonstrated that the Brief Behavioral Treatment for Insomnia (BBTI) helped cancer survivors by reducing insomnia severity and improving sleep quality. Participants generally tolerated this treatment well, with no major side effects reported.

Research has shown that the My Sleep Our Sleep (MSOS) program is also safe. It was tested with cancer patients and their partners, and the study found it both feasible and beneficial, meaning participants could follow it and found it helpful without significant issues.

Both treatments have been tested in people with cancer, and the results suggest they are safe to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new approaches to managing sleep problems in cancer patients. The Brief Behavioral Treatment for Insomnia (BBTI) is a short-term, non-drug therapy that focuses on changing sleep habits and behaviors, which could be more appealing than traditional medication options. Meanwhile, My Sleep Our Sleep (MSOS) emphasizes the involvement of both the patient and their sleep partner, aiming to improve sleep through collaborative strategies. Both treatments are unique because they combine behavioral techniques with a focus on the patient's support network, potentially offering more holistic and sustainable sleep improvements compared to standard drug therapies.

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

Research has shown that Brief Behavioral Treatment for Insomnia (BBTI), which participants in this trial may receive, works well for cancer survivors. Studies have found it significantly reduces insomnia severity and improves sleep quality over time. This treatment helps patients change their sleep habits and enhance their sleep environment.

The My Sleep Our Sleep (MSOS) program, another treatment option in this trial, also shows promise for cancer patients and their caregivers. After completing the MSOS program, both groups slept more efficiently, spending more time asleep while in bed. Both treatments have the potential to help those dealing with sleep problems related to cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Youngmee Kim, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03810365

Brief Behavioral Treatment for Insomnia in Cancer ... Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000602

Protocol of Brief Behavioral Treatment for insomnia ... This study describes the development of the Brief Behavioral Treatment for Insomnia for Couples with Cancer (BBTI-CC) intervention, which is an adapted BBTI to ...

4. link.springer.com link.springer.com/article/10.1007/s11764-024-01704-1

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.

5. academic.oup.com academic.oup.com/jncics/article/8/3/pkae041/7680549

Interventions for insomnia in cancer patients and survivors—a ... Brief Behavioral Therapy for Insomnia showed promise as a less burdensome alternative for patients in active cancer treatment. Conclusions. CBT-I is supported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051056/

Protocol of Brief Behavioral Treatment for insomnia ... This protocol is to test the feasibility and acceptability as well as to provide preliminary efficacy of the BBTI for Couples with Cancer (BBTI-CC) ...

7. sleep.pitt.edu sleep.pitt.edu/sites/default/files/assets/Instrument%20Materials/BBTI%20Review.pdf

Brief Behavioral Treatment of Insomnia Before treat- ment, patients complete a clinical interview, stan- dardized questionnaires for sleep and daytime symptoms, and 1 to 2 weeks of sleep diaries,.