Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis

M.D. Anderson Cancer Center

Status: Withdrawn

Conditions: GI Cancers; Gastrointestinal Cancer

Treatments: Other: Sleeping Disturbances

Study type: Interventional

Funder types: Other

Identifiers

NCT05044312

NCI-2021-09807 (Other Identifier)

2019-1182

Details and patient eligibility

About

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.

Full description

Primary:

• 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).

Secondary:

• Determine sleep disturbance and its types at 30 day post-discharge follow-up visit by RCSQ.
• Determine the correlation between objective sleep variables assessed using Actigraphy and Fitbit and patient-reported SD on Richard Campbell Sleep questionnaire.
• Determine the association of severity and impact of SD among Quality of recovery (QoR-15), Pittsburgh sleep quality index, MDASI-GI and Richard Campbell Sleep questionnaire, and Insomnia Severity Index (ISI).

Exploratory:

• Determine the association between the preoperative inflammatory burden, sleep health {insomnia (using Insomnia Severity Index (ISI)),sleep architecture(sleep-wake cycles usingActigraphy)}, and perioperative inflammatory responses on postoperative SD

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult GI Cancer patients admitted for elective gastrointestinal surgery.
2. Patients with an expected hospitalstay of at least 72 hours.
3. Able to be able to read and speak English.
4. Must have access to internet or use of mobile device for FitBit.

Exclusion criteria

1. <18 years of age.
2. Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Sleep Disturbances

Other group

Description:

Difficulty Sleeping

Treatment:

Other: Sleeping Disturbances