Colo-rectal CancerNCT04270500
The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period
A study testing Prehabilitation program in people with Colo-rectal Cancer and Surgery, run by Montreal General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Surgery
- What is being tested?
- Prehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 31 Dec 2022
- 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
- All adult persons scheduled for resection of malignant colorectal lesions will be included
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Sarah Atoui, MSc, 514-934-1934 ext. 43728, sarah.atoui@mail.mcgill.ca
Sender Liberman, MD
About this study
Official title: The Impact of Physical Exercise on Sleep Quality and Duration in Colorectal Cancer Patients During Prehabilitation Period: A Pilot Study
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.
Read more
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?
Read the detailed description
Participants will be referred by colorectal surgery of the MUHC-Montreal General Hospital; 100 participants will be studied. Inclusion: adult patients aged 18 years and older, of either sex undergoing colorectal cancer surgery. All adult persons scheduled for resection of malignant colorectal lesions will be included. Exclusion criteria: 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.
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
- Colo-rectal Cancer, Surgery
- Being tested
- Prehabilitation program
- Keywords
- Colo-rectal Cancer, Colo-rectal Surgery, Prehabilitation, Sleep quality, Sleep duration, Physical exercise
- Medical subject headings
- Colonic Neoplasms, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. The CHAMPS has been validated as a measure of increasing levels of physical activity in older adults.
1 METs), low-light (ie, > 1 and ≤2 METs; eg, playing cards), high-light (ie, >2 and <3 METs; eg, light walking), moderate-to-vigorous physical activity (MVPA, ≥3 METs), and "total activity" (≥2 METs)
Measured: 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
The Actiwatch-2 (Philips, Respironics) provide an objective measure of the daily activity counts.
Measured: 4 weeks before surgery and 4 weeks after the surgery
Functional capacity using the six-minute walk test (6MWT): "change" is being assessed
The 6MWT evaluates the ability to maintain a moderate level of physical activity reflecting the activities of daily living. Norms available: The six-minute walk distance in healthy adults has been reported to range from 400m to 700m. A lower score (reflecting less distance covered in 6 minutes) indicates worse function.
Measured: 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
The HADS contains seven items, each scored from 0 to 3 points for anxiety and depression. It provides summary measures on a scale of 0-21, with scores exceeding 8 suggesting the presence of a mood disorder.
Measured: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sender Liberman MD, Montreal General Hospital
- Investigators
- Sender Liberman, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreFranco Carli, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270500
- Sponsor's protocol ID
- PA-Sleep
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22048034Meyerhardt 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.
PubMed 16822844Albrecht 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.
PubMed 22641322Carli 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.
PubMed 20602503Mayo 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.
PubMed 21878237Chen 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.
PubMed 27811855Romain 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.
PubMed 29343246Lin 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.
PubMed 23357886Coles 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.
PubMed 29470704Cho 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.
PubMed 22436836Brunet 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.
PubMed 28228123Cheville 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.
PubMed 23017624Young-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.
PubMed 12719744Rabin 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.
PubMed 18473397
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Exercise on Sleep Quality and Duration in Colorectal Cancer Patients During Prehabilitation Period: A Pilot Study
- ClinicalTrials.gov ID
- NCT04270500
- Acronym / sponsor ID
- PA-Sleep
- Conditions
- Colo-rectal Cancer, Surgery
- Keywords
- Colo-rectal Cancer, Colo-rectal Surgery, Prehabilitation, Sleep quality, Sleep duration, Physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
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?
Detailed description
Participants will be referred by colorectal surgery of the MUHC-Montreal General Hospital; 100 participants will be studied. Inclusion: adult patients aged 18 years and older, of either sex undergoing colorectal cancer surgery. All adult persons scheduled for resection of malignant colorectal lesions will be included. Exclusion criteria: 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation program | Active comparator | Behavioral: Prehabilitation programThe 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) | No intervention | –Common to both groups as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult persons scheduled for resection of malignant colorectal lesions will be included
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Prehabilitation programThe 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. | Behavioural | Prehabilitation program |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed
Time frame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
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.
Sleep quality by an Actigraphy: "change" is being assessed
Time frame: 4 weeks before surgery and 4 weeks after the surgery
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 secondary outcomes
Community Health Activities Model Program for Seniors (CHAMPS) questionnaire: "change" is being assessed
Time frame: 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
Time frame: 4 weeks before surgery and 4 weeks after the surgery
Functional capacity using the six-minute walk test (6MWT): "change" is being assessed
Time frame: 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
Time frame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 22048034Davies 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.
- Background: PubMed 16822844Meyerhardt 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.
- Background: PubMed 22641322Albrecht 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.
- Background: PubMed 20602503Carli 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.
- Background: PubMed 21878237Mayo 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.
- Results publication: PubMed 27811855Chen 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.
- Results publication: PubMed 29343246Romain 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.
- Results publication: PubMed 23357886Lin 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.
- Results publication: PubMed 29470704Coles 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.
- Results publication: PubMed 22436836Cho 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.
- Results publication: PubMed 28228123Brunet 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.
- Results publication: PubMed 23017624Cheville 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.
- Individual participant dataSharing planned: No
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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.
Sender Liberman, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Franco Carli, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation program in people with Colo-rectal Cancer and Surgery, run by Montreal General Hospital at 1 site in Canada.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Atoui, MSc (514-934-1934 ext. 43728, sarah.atoui@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed (time frame: At the baseline, it will be repeated the week of the surgery and at 4 and 8 weeks after the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270500, which also lists 14 linked publications.
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 7 Apr 2022.