GI CancersNCT05044312
Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
A study testing Sleeping Disturbances in people with GI Cancers and Gastrointestinal Cancer, run by M.D. Anderson Cancer Center.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Cancers, Gastrointestinal Cancer
- What is being tested?
- Sleeping Disturbances
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2020to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult GI Cancer patients admitted for elective gastrointestinal surgery.
- Patients with an expected hospitalstay of at least 72 hours.
- Able to be able to read and speak English.
- Must have access to internet or use of mobile device for FitBit.
Who cannot join
- <18 years of age.
- Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.
About this study
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.
Read the detailed 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
- Conditions
- GI Cancers, Gastrointestinal Cancer
- Being tested
- Sleeping Disturbances
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeping DisturbancesOther
most common complaints of patients after surgery and may affect the ability to carry out daily activities, quality of life, and post-surgery recovery.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Disturbances | Other | Difficulty Sleeping Receives: Other: Sleeping Disturbances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
This questionnaire will be used to assess during the stay by using (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire(RCSQ). scale of 1 to 10 (with 1 being "poor" and 10 being "excellent
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start6 Mar 2020 (estimated)
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Why it stopped: PI requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Sriram Yennu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044312
- Sponsor's protocol ID
- 2019-1182
- Other IDs
- NCI-2021-09807
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
- ClinicalTrials.gov ID
- NCT05044312
- Acronym / sponsor ID
- 2019-1182
- Conditions
- GI Cancers, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI requested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 6 Mar 2020 (estimated)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Disturbances | Other | Other: Sleeping DisturbancesDifficulty Sleeping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult GI Cancer patients admitted for elective gastrointestinal surgery.
- Patients with an expected hospitalstay of at least 72 hours.
- Able to be able to read and speak English.
- Must have access to internet or use of mobile device for FitBit.
Key exclusion criteria (2 listed)
- <18 years of age.
- Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeping Disturbancesmost common complaints of patients after surgery and may affect the ability to carry out daily activities, quality of life, and post-surgery recovery. | Other | Sleep Disturbances |
Primary outcome
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
Time frame: through study completion, an average of 1 year
This questionnaire will be used to assess during the stay by using (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire(RCSQ). scale of 1 to 10 (with 1 being "poor" and 10 being "excellent
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Yennu principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Sleeping Disturbances in people with GI Cancers and Gastrointestinal Cancer, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.