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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to determine sleep disturbance and its types among patients with gastrointestinal cancers during the perioperative period (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire (RCSQ). The primary objective of this study is to determine the SD during preoperative and post-operative periods evaluated by Richard Campbell Sleep questionnaire. Patients will be asked every 24 hours while at the hospital (before and after surgery) to fill out this questionnaire. The mean RCSQ score at each time point (i.e., before and after surgery) will be calculated for each patient. The overall mean (across all patients) will be calculated and reported along a 95% CI.

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 data supports the effectiveness of the treatment Sleeping Disturbances for gastrointestinal cancer patients?

Research shows that sleep-promoting interventions can have beneficial effects on recovery and quality of life for cancer patients, suggesting that addressing sleep disturbances may help improve these aspects for those with gastrointestinal cancers. ^{1 2 3 4 5}

Is the treatment for sleep disturbances in gastrointestinal cancer patients safe?

The research does not provide specific safety data for the treatment of sleep disturbances in gastrointestinal cancer patients, but it discusses the impact of sleep disturbances on quality of life and symptom severity in cancer patients. ^{1 2 6 7 8}

How does this treatment for sleep disturbances in gastrointestinal cancer patients differ from other treatments?

This treatment is unique because it specifically targets sleep disturbances in patients with gastrointestinal cancer, which are often exacerbated during chemotherapy. Unlike standard cancer treatments that focus solely on the cancer itself, this approach aims to improve patients' quality of life by addressing sleep issues, which can enhance overall health and potentially improve treatment outcomes. ^{1 2 8 9 10}

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Able to read and speak English

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

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

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

Sleep quality in individuals diagnosed with colorectal cancer: Factors associated with sleep disturbance as patients transition off treatment. [2019]

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

Distinct Sleep Disturbance Profiles in Patients With Gastrointestinal Cancers Receiving Chemotherapy. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Incorporating measures of sleep quality into cancer studies. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Comparison of subjectively and objectively assessed sleep problems in breast cancer patients starting neoadjuvant chemotherapy. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Fatigue and sleep disorders of patients with colorectal cancer]. [2015]

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

The relationship of sleep disturbance and symptom severity, symptom interference, and hospitalization among Israeli inpatients with cancer. [2015]

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

Distinct sleep disturbance profiles among patients with gynecologic cancer receiving chemotherapy. [2022]

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

Sleep disturbances in hospitalized patients with cancer. [2015]

9. Cyprus pubmed.ncbi.nlm.nih.gov

Subjective sleep quality of cancer patients. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Sleep disorders and cancer: State of the art and future perspectives. [2021]