The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period

NCT04270500 | Unknown DMC

• 1 other identifier: PA-Sleep
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: To evaluate the bidirectional relationships between physical exercise and sleep parameters, as a part of multimodal prehabilitation intervention, on pre- and postoperative outcomes in surgical patients with colorectal cancer, in an RCT. Secondary objective: to determine whether the levels of anxiety and depression affect these relationships. Objectives are based on the overarching hypothesis that is sleep and physical activity influence each other through complex, reciprocal interactions including multiple physiological and psychological pathways. To achieve this, providing a multimodal prehabilitation, specifically physical exercise, involved in mental and physical health through different mechanisms, i.e., improving physical functioning and fitness, reducing side effects of cancer treatments, preventing bone loss and weight gain, improving the quality of life and sleep, decreasing symptoms of fatigue and depression. The present is a pilot study aiming to evaluate the bidirectional relationships between sleep and physical exercise, and the preliminary outcome has important implications for informing both clinical and public health practice. Research question: Does a multimodal intervention including physical exercise improve sleep quality and duration compared to standard of care, during the perioperative period? Conversely, does a better sleep quality and duration increases the level of physical exercise during the perioperative period? How the level of anxiety and depression will affect these relationships? If the Prehabilitation program specifically physical exercise will positively affect sleep quality and duration after surgery, in the way to be a protective factor of sleep to not be reduced by up to 55% compared to those receiving standard of care?

Conditions

Colo-rectal Cancer; Surgery

Keywords

Colo-rectal Cancer; Colo-rectal Surgery; Prehabilitation; Sleep quality; Sleep duration; Physical exercise

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed

  This questionnaire was developed to assess the global subjective sleep disturbances of the previous month. The PSQI is a 19-item self-report measure of broad sleep disturbances over the past month and yields 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction), which are added to create a total score. Each score ranging from 0 to 3 and a total score range of 0-21, a score of 0 indicated no sleep problems and 3 indicated serious sleep problems.

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

• Sleep quality by an Actigraphy: "change" is being assessed

  Sleep quality will be objectively measured using the Actiwatch-2. The Actiwatch-2 (Philips, Respironics) is a small, waterproof, non-intrusive actigraphy device that is worn on the wrist of the non-dominant hand. By calculating orientation and movement, actigraphy records sleep-wake activity and provide an objective measure of sleep quality.

  4 weeks before surgery and 4 weeks after the surgery

Secondary Outcomes (4)

• Community Health Activities Model Program for Seniors (CHAMPS) questionnaire: "change" is being assessed

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

• Daily activity counts measured by an Actigraphy: "change" is being assessed

  4 weeks before surgery and 4 weeks after the surgery

• Functional capacity using the six-minute walk test (6MWT): "change" is being assessed

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

• Hospital Anxiety and Depression Scale (HADS): "change" is being assessed

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

Other Outcomes (14)

• Insomnia Severity Index (ISI): "change" is being assessed

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

• Chronotype: "change" is being assessed

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

• Health-related quality of life will be assessed using the Medical Outcomes Study 36-Item: "change" is being assessed Short-Form Health Survey (SF-36)

  At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.

Study Arms (2)

Prehabilitation program

ACTIVE COMPARATOR

The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.

Behavioral: Prehabilitation program

Standard of care (SOC)

NO INTERVENTION

Common to both groups as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution.

Interventions

Prehabilitation program BEHAVIORAL

The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.

Prehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult persons scheduled for resection of malignant colorectal lesions will be included

You may not qualify if:

• A compromised health status (American Society of Anesthesiologists \[ASA\] class 4-5) or comorbid medical conditions interfering with the ability to perform an exercise.
• Patients are unable to understand the information given, insufficient understanding of English or French language to provide informed consent or who are considered unable to perform study-specific procedures.
• Patients that diagnosis of a sleep disorder other than insomnia (e.g., sleep-disordered breathing) or received psychotherapy specifically for insomnia, as well as a night-shift worker in the past 3 months or the next 18 months will be excluded

Sponsors & Collaborators

• Montreal General Hospital: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (14)

• Davies NJ, Batehup L, Thomas R. The role of diet and physical activity in breast, colorectal, and prostate cancer survivorship: a review of the literature. Br J Cancer. 2011 Nov 8;105 Suppl 1(Suppl 1):S52-73. doi: 10.1038/bjc.2011.423.

  PMID: 22048034 BACKGROUND

• Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. doi: 10.1200/JCO.2006.06.0855. Epub 2006 Jul 5.

  PMID: 16822844 BACKGROUND

• Albrecht TA, Taylor AG. Physical activity in patients with advanced-stage cancer: a systematic review of the literature. Clin J Oncol Nurs. 2012 Jun 1;16(3):293-300. doi: 10.1188/12.CJON.293-300.

  PMID: 22641322 BACKGROUND

• Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.

  PMID: 20602503 BACKGROUND

• Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.

  PMID: 21878237 BACKGROUND

• Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3.

  PMID: 27811855 RESULT

• Romain B, Rohmer O, Schimchowitsch S, Hubner M, Delhorme JB, Brigand C, Rohr S, Guenot D. Influence of preoperative life satisfaction on recovery and outcomes after colorectal cancer surgery - a prospective pilot study. Health Qual Life Outcomes. 2018 Jan 17;16(1):16. doi: 10.1186/s12955-017-0824-4.

  PMID: 29343246 RESULT

• Lin KY, Shun SC, Lai YH, Liang JT, Tsauo JY. Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. Cancer Nurs. 2014 Mar-Apr;37(2):E21-9. doi: 10.1097/NCC.0b013e3182791097.

  PMID: 23357886 RESULT

• Coles T, Bennett AV, Tan X, Battaglini CL, Sanoff HK, Basch E, Jensen RE, Reeve BB. Relationship between sleep and exercise as colorectal cancer survivors transition off treatment. Support Care Cancer. 2018 Aug;26(8):2663-2673. doi: 10.1007/s00520-018-4110-8. Epub 2018 Feb 22.

  PMID: 29470704 RESULT

• Cho MH, Dodd MJ, Cooper BA, Miaskowski C. Comparisons of exercise dose and symptom severity between exercisers and nonexercisers in women during and after cancer treatment. J Pain Symptom Manage. 2012 May;43(5):842-54. doi: 10.1016/j.jpainsymman.2011.05.016. Epub 2012 Mar 19.

  PMID: 22436836 RESULT

• Brunet J, Burke S, Grocott MP, West MA, Jack S. The effects of exercise on pain, fatigue, insomnia, and health perceptions in patients with operable advanced stage rectal cancer prior to surgery: a pilot trial. BMC Cancer. 2017 Feb 23;17(1):153. doi: 10.1186/s12885-017-3130-y.

  PMID: 28228123 RESULT

• Cheville AL, Kollasch J, Vandenberg J, Shen T, Grothey A, Gamble G, Basford JR. A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):811-21. doi: 10.1016/j.jpainsymman.2012.05.006. Epub 2012 Sep 24.

  PMID: 23017624 RESULT

• Young-McCaughan S, Mays MZ, Arzola SM, Yoder LH, Dramiga SA, Leclerc KM, Caton JR, Sheffler RL, Nowlin MU. Research and commentary: Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Oncol Nurs Forum. 2003 May-Jun;30(3):441-54; discussion 441-54. doi: 10.1188/03.ONF.441-454.

  PMID: 12719744 RESULT

• Rabin C, Pinto B, Dunsiger S, Nash J, Trask P. Exercise and relaxation intervention for breast cancer survivors: feasibility, acceptability and effects. Psychooncology. 2009 Mar;18(3):258-66. doi: 10.1002/pon.1341.

  PMID: 18473397 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Officials

• Sender Liberman, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Franco Carli, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Atoui, MSc

CONTACT

514-934-1934; sarah.atoui@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized controlled pilot trial of patients with colorectal cancer scheduled for major abdominal surgery. The prehabilitation intervention group will be compared with the usual care for an average of 4 weeks before planned surgery. All participants will wear an actigraphy to objectively assess their daily physical activity and their sleep behavior. The intervention will last for 4 weeks pre- and 8 weeks post-surgery, for a total of 12 weeks. Site visits will occur weekly before surgery and every 4 weeks after surgery. In that period, weekly phone calls will reinforce compliance and provide tips to help patients adhere to the treatment protocol. A dedicated and specially trained research team lead by a physician, a kinesiologist, a nutritionist and a psychologist will perform the measurements and collect the demographic and surgical details of all the patients, recording daily detailed information of clinical outcomes up to 8 weeks after surgery.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 17, 2020
• Study Start: September 15, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)