The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period
NCT ID: NCT04270500
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-09-15
2022-12-31
Brief Summary
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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?
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Detailed Description
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Study Design: Randomized controlled trial of two parallel arms: prehabilitation program and standard of care (SOC). Informed consent forms will be signed and dated before the conduct of any study-specific procedures. After baseline assessment, participants will be random, by a computer program, allocated to either an intervention or a control group. Duration and follow-up. 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.
Interventions: Common to both groups: as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution. All participants will wear an actigraphy to objectively assess their daily physical activity and their sleep behavior. The following outcomes will be assessed for all participants, at the baseline and will be repeated after 4 weeks, before and after the surgery: sleep behaviors included sleep quality and duration, assessed subjectively and objectively. Self-reported and objective outcome measurements will be assessed from all participants such as the 6-minute walk distance (6MWD), daily activity counts, exercise tolerance (CPET) and handgrip strength, Insomnia Severity Index (ISI), Chronotype, health-related quality of life assessed by using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS) used to assess emotional distress.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
NONE
Study Groups
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Prehabilitation program
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
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.
Standard of care (SOC)
Common to both groups as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution.
No interventions assigned to this group
Interventions
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Prehabilitation program
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Montreal General Hospital
OTHER
Responsible Party
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Sender Liberman MD
Principal Investigator
Principal Investigators
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Sender Liberman, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Franco Carli, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PA-Sleep
Identifier Type: -
Identifier Source: org_study_id
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