Sleep Disturbance Analysis for Gastrointestinal Cancer

Overseen By Sriram Yennu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 18, Night shift workers

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how sleep disturbances affect patients with gastrointestinal (GI) cancer around the time of their surgery. Researchers aim to identify the types of sleep issues that occur before and after surgery using a simple sleep questionnaire. The goal is to find patterns in sleep disturbances to improve care for GI cancer patients. Adults with GI cancer scheduled for surgery and a hospital stay of at least three days may qualify for this trial. Participants must be able to read and speak English and have access to the internet or a mobile device for using a FitBit. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance patient care and recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for evaluating sleep disturbances in gastrointestinal cancer patients?

Research has shown that sleep problems are common among cancer patients. In one study, 62% of cancer patients reported moderate to severe sleep issues, indicating that sleep problems are often part of the cancer experience.

Although this study does not test a treatment for sleep disturbances, understanding their impact is important. Sleep issues, such as trouble falling asleep or waking up frequently, can affect overall well-being. However, no direct evidence from the sources indicates safety concerns specifically related to studying sleep problems in cancer patients.

Since this study does not involve testing a new drug or treatment, there is no risk from taking a new medication. The study focuses on observing and measuring sleep patterns using a questionnaire. This method is safe and non-invasive, as it does not involve any medical procedures or medications. Participants will simply answer questions about their sleep, which is a low-risk activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the relationship between sleep disturbances and gastrointestinal cancer. Unlike traditional treatments that focus solely on managing the cancer itself, this study looks at how sleep issues might impact the condition and patient well-being. By understanding this connection, it could lead to more holistic approaches in treatment plans, potentially improving quality of life for those affected. This trial is unique because it shifts the focus from tumor-centric strategies to a broader perspective, considering the overall health and experiences of the patient.

What evidence suggests that this trial's method could be effective for analyzing sleep disturbances in gastrointestinal cancer patients?

This study aims to understand sleep problems in people with gastrointestinal cancer around the time of their surgery. Research has shown that sleep issues are common in cancer patients, often due to the stress of the illness and treatment. Although this study doesn't test a treatment, previous research found that sleep quality can impact recovery and overall health. Researchers will use the Richard Campbell Sleep Questionnaire to measure the frequency of sleep problems in these patients. Understanding these patterns may help identify ways to improve sleep, potentially leading to better health outcomes for patients.

Who Is on the Research Team?

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult patients with gastrointestinal cancers who are scheduled for elective surgery and will be in the hospital for at least 3 days. Participants must be able to read and speak English and have internet access or a mobile device compatible with FitBit.

Inclusion Criteria

Must have access to internet or use of mobile device for FitBit

I will be in the hospital for at least 3 days.

I am an adult with GI cancer scheduled for elective GI surgery.

Exclusion Criteria

I am under 18 years old.

Night shift workers obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants' sleep disturbances are assessed using the Richard Campbell Sleep Questionnaire before surgery

1 week

Daily assessments (in-hospital)

Postoperative

Participants' sleep disturbances are assessed using the Richard Campbell Sleep Questionnaire after surgery

1 week

Daily assessments (in-hospital)

Follow-up

Participants are monitored for sleep disturbances at a 30-day post-discharge follow-up visit

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sleeping Disturbances

Trial Overview The study aims to measure sleep disturbances in GI cancer patients during their hospital stay using the Richard Campbell Sleep Questionnaire. Patients will complete this survey daily before and after surgery to assess changes in their sleep quality.

How Is the Trial Designed?

Group I: Sleep Disturbances Experimental Treatment 1 Intervention

Difficulty Sleeping

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10465665/

Are sleep disorders associated with the risk of gastrointestinal ... In conclusion, our data did not show a significant association between sleep disorders and GI cancers in the overall history. Interestingly, ...

2. nature.com nature.com/articles/s41598-025-18402-2

Associations between sleep and the gut microbiome in ... A systematic review concluded that over 72% of caregivers of patients with advanced cancer reported moderate to severe levels of sleep ...

3. cancerworld.net cancerworld.net/sleep-cancer-why-rest-matters-more-than-you-think/

Sleep & Cancer: Why Rest Matters More Than You Think? A randomised study found that snoring was associated with higher rectal and colon cancer risk. Difficulty sleeping or frequent awakenings have ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1336487/full

Sleep disorders and cancer incidence: examining duration ... Results from the current analysis support other evidence suggesting that cancer risks associated with sleep disruption may take up to a decade ...

5. sleepmedres.org sleepmedres.org/journal/view.php?number=65

Sleep Disturbances in Cancer: A Review Results showed that 62% of the cancer patients reported moderate to severe sleep disturbance, while 53% of the depressed patients and only 30% ...