Sleep Treatments for Gastrointestinal Cancer

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: 5

Duration: 13 weeks

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore sleep habits and test new methods to improve sleep for individuals with gastrointestinal cancer and their caregiver partners. The researchers are testing two treatments: the My Sleep Our Sleep (MSOS) program and Brief Behavioral Treatment for Insomnia (BBTI). Individuals diagnosed with any stage of GI cancer within the past year and who have a consistent sleep partner may qualify. The study targets those experiencing sleep difficulties and open to trying new sleep habits. As an unphased trial, participants can contribute to pioneering research that may enhance sleep quality for cancer patients and their caregivers.

Do I need to stop my current medications for the trial?

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?

Research shows that the My Sleep Our Sleep (MSOS) program is practical and well-received by adults with cancer and their partners. Studies indicate that participants use this program without major issues and find it helpful for managing sleep problems.

Regarding the Brief Behavioral Treatment for Insomnia (BBTI), research has found it effective in reducing insomnia and improving sleep quality. Cancer survivors who tried this treatment tolerated it well, with no significant reports of harmful effects.

Both treatments have been tested in similar groups and have shown positive results in improving sleep. This suggests they are safe options for those interested in joining a clinical trial focused on sleep issues in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer non-drug approaches to improve sleep for gastrointestinal cancer patients, which can be a big deal compared to standard options like medication. The Brief Behavioral Treatment for Insomnia (BBTI) uses simple behavioral strategies to help patients get better sleep, making it a gentler option with potentially fewer side effects than sleeping pills. The My Sleep Our Sleep (MSOS) program involves both patients and their caregivers in the treatment process, fostering a supportive sleep environment that could enhance overall well-being. By focusing on behavioral and collaborative methods, these treatments might provide effective sleep solutions without the risks associated with pharmaceuticals.

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

Research has shown that the Brief Behavioral Treatment for Insomnia (BBTI), which participants in this trial may receive, helps cancer survivors sleep better. It significantly reduces insomnia severity and enhances sleep quality. Over 85% of participants reported better sleep after BBTI. Meanwhile, the My Sleep Our Sleep (MSOS) program, another treatment option in this trial, has also proven effective. Both patients and their caregivers experienced improved sleep. This program is particularly beneficial for cancer patients and their sleep partners. ^{1 2 3 4 6}

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 adult patients recently diagnosed with stages I-IV gastrointestinal cancer and their sleep partners who are willing to improve sub-optimal sleep habits. Both must read and speak English or Spanish at an 8th grade level, have a PSQI score ≥ 5, be over 4 weeks post-surgery with no upcoming surgeries planned during the study.

Inclusion Criteria

Both patients and caregivers must be able to read English or Spanish at the 8th grade level for self-reported questionnaires

Both patients and caregivers must be able to speak/listen English at the 8th grade level for intervention sessions

Caregivers must be sleep partners of the patient

Exclusion Criteria

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

I have depression, psychosis, or bipolar disorder that is not being treated.

I do not have extreme sleep patterns, major travel plans, or severe sensory or cognitive impairments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the My Sleep Our Sleep (MSOS) intervention or the Brief Behavioral Treatment for Insomnia (BBTI) for up to 13 weeks

13 weeks

Baseline, week 5, and week 13 assessments

Follow-up

Participants are monitored for changes in sleep disturbance and insomnia symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study aims to understand sleep behaviors in cancer patients and their caregivers by testing two programs: 'My Sleep Our Sleep' (MSOS) and 'Brief Behavioral Treatment for Insomnia' (BBTI). Participants will learn ways to manage insomnia related to cancer care.

How Is the Trial Designed?

Group I: 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 13 weeks.

Group II: 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 13 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+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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. withpower.com withpower.com/trial/phase-gastrointestinal-cancers-9-2024-fac44

Sleep Treatments for Gastrointestinal Cancer The Brief Behavioral Treatment for Insomnia (BBTI) significantly improved sleep efficiency in lung cancer survivors, with over 85% of participants showing ...

3. academic.oup.com academic.oup.com/sleep/article-abstract/47/Supplement_1/A168/7654157

0391 Effects of Brief Behavioral Treatment for Insomnia on ... BBTI was significantly effective in reducing insomnia severity and improving sleep quality overtime compared to control among cancer survivors with insomnia ...

4. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/10.1111/wvn.70075?af=R

Comparative Efficacy of Brief Behavioral Therapy for Insomnia ... Primary outcomes were insomnia severity and sleep quality. Secondary outcomes included total sleep time, sleep onset latency, wake after sleep ...

5. 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, ...

6. aasm.org aasm.org/wp-content/uploads/2022/07/ProviderFS-BBTI.pdf

Brief Behavioral Treatment for Insomnia (BBTI) Cognitive Behavioral Therapy for Insomnia (CBT-I) is a type of psychological treatment that utilizes stimulus control, sleep restriction, relaxation training ...