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

Trial Summary

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.

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

Research shows that BBTI, a simplified version of cognitive behavioral therapy for insomnia, has been effective in improving sleep and quality of life in lung cancer survivors and veterans with insomnia. This suggests it may also help gastrointestinal cancer patients with sleep issues. ^{1 2 3 4 5}

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

BBTI has been studied in various groups, including veterans and lung cancer survivors, and no significant safety concerns have been reported. It is a non-drug treatment that focuses on improving sleep habits and behaviors, making it generally safe for humans. ^{1 2 4 5 6}

How does the treatment BBTI differ from other treatments for insomnia in gastrointestinal cancer patients?

BBTI is unique because it is a brief, nurse-delivered therapy that adapts cognitive behavioral therapy for insomnia (CBTI) to be more accessible and practical, especially for those with limited access to trained psychologists. It focuses on improving sleep efficiency and quality of life through a structured, short-term program that can be administered in medical settings by nonpsychologist health professionals. ^{1 2 3 6 7}

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 caregiver partners.

Research Team

Youngmee Kim, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

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

Brief Behavioral Treatment of Insomnia. [2019]

7. 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]