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Trial record 1 of 1 for:    NCT03254836
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Sleep and Survival in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254836
Recruitment Status : Active, not recruiting
First Posted : August 21, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Center of Surgical Science, Department of Surgery, Zealand University Hospital
Information provided by (Responsible Party):
Michael Tvilling Madsen, Zealand University Hospital

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

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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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254836


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

Additional Information:

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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    Key Record Dates
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

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