Sleep and Survival in Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT03254836
• Recruitment Status: Active, not recruiting
• First Posted: August 21, 2017
• Last Update Posted: January 15, 2019
• Sponsor: Zealand University Hospital
• Collaborator: Center of Surgical Science, Department of Surgery, Zealand University Hospital
• Information provided by (Responsible Party): Michael Tvilling Madsen, Zealand University Hospital

Study Description

Brief Summary:

Objective The objective of the current trial is to investigate the effect of perioperative sleep and circadian rhythm on the natural course of survival among patient diagnosed with colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life, and co-morbidity will be measured continuously in the short-, intermediate- and long-term period following diagnosis.

The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at baseline are expected to result in overall universally reduced quality of life, increased depression and fatigue. Furthermore, development of sleep-wake disturbances in the postoperative period as compared to preoperative sleep-wake rhythm is expected to a prognostic marker of negative outcomes.

Target and study population The study population are all patients diagnosed with colorectal cancer in Region Zealand recruited consecutively from the trial initiation until study end each patient with an intended 5 year follow-up period. All available cases will be included in the trial.

Study design The study will be an observational prospective cohort study applying a longituditional repeated measure design.

Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian outcomes measured via actigraphy in the perioperative period.

Furthermore, cancer related survival and overall survival in the 5 year follow-up period is considered primary outcomes.

Secondary outcomes consist of consecutively measured depression, fatigue, quality of life, follow-up treatment and co-morbidity.

Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment, oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the secondary outcomes could be expected to serve as confounding or mediating factors.

Meaningful control for confounding will in the analysis phase be cancer stage and baseline sleep-wake rhythm status.

Sampling methods All available cases will be sought included in the trial. No formal sample size has been performed and continues inclusion into the trial will be performed during an 1,5 year period.

Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm will be investigated using survival statistics and/or multivariate logistic regression.

Expected results The investigators expect to see a marked difference in overall survival among patients with sleep and circadian disturbances at baseline.

Condition or disease	Intervention/treatment
Colorectal Neoplasm; Circadian Rhythm Sleep Disorder; Depression; Quality of Life; Sleep	Other: Standard of care

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: Sleep-wake Rhythm in the Perioperative Period in Patients Admitted for Elective Radical Surgery for Colorectal Cancer: an Observational Prospective Cohort Study.
• Actual Study Start Date: March 1, 2017
• Actual Primary Completion Date: July 31, 2018
• Estimated Study Completion Date: July 31, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Colorectal cancer undergoing elective surgery; All patients eligible for elective curative intended surgery for colonic adenocarcinoma at Zealand University Hospital. Patients will recieve treatment as per standard of care.	Other: Standard of care; Elective radical surgery for adenocarcinoma.

Outcome Measures

Primary Outcome Measures :

1. Actigraphy [ Time Frame: Approximately 1 week preoperatively to 2 weeks postoperatively ]
   Assessment of activity using accelerometor - Sleep and circadian assesment.

Secondary Outcome Measures :

1. Major Depression Inventory [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   Assesment of depression
2. Insomnia Severity Index [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   Subjective sleep assesment
3. Quality of life assesment [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   EORCT-QLQ-C30
4. Quality of life assesment [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   EORCT-QLQ-CR29
5. Mortality [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   Baseline registration and follow-up assessments
6. Co-morbidity [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   Baseline registration and follow-up assessments
7. Drug prescription history (Drug name and dosage) [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   Baseline registration and follow-up assessments
8. Follow-up cancer treatment (Adjuvant chemotherapy, timing and duration) [ Time Frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively. ]
   Baseline registration and follow-up assessments

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for elective curative intended surgery for colonic or rectal adenocarcinoma at Zealand University Hospital.

Criteria

Inclusion Criteria:

• Diagnosis of colorectal cancer as determined at the multi-disciplinary team conference.
• Admitted to elective radical surgery at the department of surgery at Zealand University Hospital
• Age above 18 years
• Informed consent

Exclusion Criteria:

• Non-ability to complete the study as assessed by the investigator
• Non-fluent in Danish.
• History of cognitive impairment (e.g. dementia)
• Paralysis or inability to answer study questioners electronically.
• Stadium 4 colonic adenocarcinoma with no surgical treatment options as determined at the multi-disciplinary conference.

Contacts and Locations

Locations

Denmark

Department of Surgery, Zealand University Hospital

Roskilde, Zealand, Denmark, 4000

Sponsors and Collaborators

Zealand University Hospital

Center of Surgical Science, Department of Surgery, Zealand University Hospital

Investigators

• Principal Investigator: Michael T Madsen, M.D.; Department of Surgery, Zealand University Hospital

More Information

Additional Information:

• Responsible Party: Michael Tvilling Madsen, M.D., Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT03254836
• Other Study ID Numbers: MTM-V3; SJ-600 ( Other Identifier: Region Zealand ethics Comittee )
• First Posted: August 21, 2017
• Last Update Posted: January 15, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Contact to study investigators avaliable at mitm@regionsjaelland.dk

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Tvilling Madsen, Zealand University Hospital:

Actigraphy; Major Depression Inventory (MDI); Insomnia Severity Index (ISI)

Additional relevant MeSH terms:

Colorectal Neoplasms; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Depression; Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nervous System Diseases; Neurologic Manifestations; Chronobiology Disorders; Dyssomnias; Occupational Diseases