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Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multimodal prehabilitation
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Psychological prehabilitation, Colorectal cancer, Functional capacity, Physical activity, Nutrition, Psychological counselling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently aged 18 years or older
  • Diagnosed with non-metastatic, colorectal cancer
  • Awaiting resection of malignant colorectal lesions
  • Able to provide informed consent in English or in French

Exclusion Criteria:

- Have health condition(s) interfering with ability to safely perform exercise at home or to complete testing procedures (e.g., non-ambulatory, dementia, severe end-organ disease, morbid obesity, cardiac abnormalities)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention Group

    Arm Description

    4-week multimodal preoperative intervention (i.e., Prehabilitation) consisting of an aerobic and strength training program, nutritional counselling and psychological support to help improve physical and psychological health prior to surgical resection of colorectal cancer.

    Outcomes

    Primary Outcome Measures

    Functional capacity: Six-minute walk test (Enright, 2003)
    Change in participants' performance on the six-minute walk test (6MWT) across baseline (week 0), and post-intervention (week 4). The 6MWT measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.

    Secondary Outcome Measures

    Postoperative complications: Clavien Classification (Dindo, Demartines & Clavien, 2004)
    Postoperative complications (e.g., pneumonia, urinary tract infection, hemorrhage, bile leak) following colorectal resection will be measured and scored using the Clavien Classification. Each complication is graded between I ('Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy') to V ('Death of a patient') with higher grades indicating greater severity of complication.
    Depressive and anxiety symptoms: The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
    Change in participants' self-reported anxiety and depressive symptoms across baseline (week 0), and post-intervention (week 4). Each item is scored on a 0 (e.g., 'Definitely as much') to 4 (e.g., 'Hardly at all') scale with higher scores representing greater severity of anxiety and depressive symptoms.
    Health related quality of life: RAND 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
    Change in participants' self-reported quality of life across baseline (week 0), and post-intervention (week 4). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0-100 scale, with higher scores representing a more favourable health state.
    Physical activity: Community Health Activities Model Program for Seniors (CHAMPS; Stewart et al., 2001)
    Change in participants' self-reported physical activity levels across baseline (week 0), and post-intervention (week 4). CHAMPS measures the average number of hours individuals report engaging in 41 different activities (or varying intensities) during a typical week. Metabolic equivalent of task (MET) scores are calculated for activities engaged in at mild, moderate and vigorous intensity with higher scores indicating higher levels of engagement.
    Lower body strength: Sit-to-Stand test (Bohannon, 1995)
    Change in participants' objective performance on the sit-to-stand test across baseline (week 0), and post-intervention (week 4). The sit-to-stand test measures lower body strength by recording the maximum number of times an individual can go from a seated position to a standing position, without using their arms, in a 30-second period.
    Nutritional status: body weight loss, serum albumin, hand grip strength, body mass index, lean body mass and percentage of body fat
    Change in nutritional status across baseline (week 0), and post-intervention (week 4). Body mass index (kg/m2), lean body mass and percentage of body fat will be measured using a bioimpedance machine. Self-reported body weight loss in the preceding three months will be recorded. Serum albumin will be measured via blood draw.

    Full Information

    First Posted
    January 28, 2020
    Last Updated
    January 29, 2020
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04248647
    Brief Title
    Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.
    Official Title
    Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection. Modalities to Mitigate the Level of Anxiety and Depression Prior to Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 26, 2016 (Actual)
    Primary Completion Date
    April 1, 2018 (Actual)
    Study Completion Date
    April 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Psychological distress is common among adults newly diagnosed with cancer and those awaiting cancer treatment(s). Although preoperative psychological distress has been shown to be associated with poorer physical health and adverse treatments among colorectal cancer survivors, few psychological interventions have been developed to reduce distress, and improve physical health in the preoperative period. Moreover, whether a preoperative psychological intervention, delivered in addition to a multimodal Prehabilitation program can improve psychological and physical health remains unknown. Therefore, the purpose of this pilot cohort study was to examine the impact of a structured psychological intervention, given in addition to standard Prehabilitation, on preoperative psychological health and functional capacity in colorectal cancer patients awaiting surgery.
    Detailed Description
    All participants will receive a multimodal prehabilitation program preoperatively for 4 weeks, composed of three elements: aerobic and strength training exercise program, nutritional counselling and psychological support. The exercise program will be three times per week and include a combination of home-based (twice per week) and supervised (once per week) sessions. Participants' nutritional status and dietary intake will be assessed by a registered dietician/nutritionist, and a whey protein supplement (Immunocal) will be prescribed to achieve a daily intake of 1.5 g protein/kg. Psychological support will consist of a 90-minute interview/session at baseline and weekly in-person follow-ups before surgery aimed at reducing psychological distress and improving adherence to the exercise program and nutritional recommendations. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Psychological prehabilitation, Colorectal cancer, Functional capacity, Physical activity, Nutrition, Psychological counselling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    4-week multimodal preoperative intervention (i.e., Prehabilitation) consisting of an aerobic and strength training program, nutritional counselling and psychological support to help improve physical and psychological health prior to surgical resection of colorectal cancer.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multimodal prehabilitation
    Intervention Description
    This arm will receive a 4-week prehabilitation program consisting of: Exercise: Participants will receive a 3x/week aerobic and strength training exercise program. They will perform 2 workouts per week at home and attend an in-hospital supervised exercise session once per week. Nutritional counselling: Participants will meet with a registered dietician who will provide personalized nutritional recommendations and a whey protein supplement, tailored according to participants' self-reported dietary intake and anthropometric measurements. Psychological support: Participants will receive a 90-minute session at baseline, and weekly in-hospital follow-ups throughout the preoperative period. The sessions will aim to reduce preoperative distress and improve adherence to the exercise program and nutritional recommendations. Psychological support will be delivered by a trained master's student, under the direct supervision of a registered Clinical Psychologist.
    Primary Outcome Measure Information:
    Title
    Functional capacity: Six-minute walk test (Enright, 2003)
    Description
    Change in participants' performance on the six-minute walk test (6MWT) across baseline (week 0), and post-intervention (week 4). The 6MWT measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.
    Time Frame
    Baseline (week 0), post-intervention (week 4)
    Secondary Outcome Measure Information:
    Title
    Postoperative complications: Clavien Classification (Dindo, Demartines & Clavien, 2004)
    Description
    Postoperative complications (e.g., pneumonia, urinary tract infection, hemorrhage, bile leak) following colorectal resection will be measured and scored using the Clavien Classification. Each complication is graded between I ('Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy') to V ('Death of a patient') with higher grades indicating greater severity of complication.
    Time Frame
    8-weeks post-surgery (week 12)
    Title
    Depressive and anxiety symptoms: The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
    Description
    Change in participants' self-reported anxiety and depressive symptoms across baseline (week 0), and post-intervention (week 4). Each item is scored on a 0 (e.g., 'Definitely as much') to 4 (e.g., 'Hardly at all') scale with higher scores representing greater severity of anxiety and depressive symptoms.
    Time Frame
    Baseline (week 0), post-intervention (week 4)
    Title
    Health related quality of life: RAND 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
    Description
    Change in participants' self-reported quality of life across baseline (week 0), and post-intervention (week 4). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0-100 scale, with higher scores representing a more favourable health state.
    Time Frame
    Baseline (week 0), post-intervention (week 4)
    Title
    Physical activity: Community Health Activities Model Program for Seniors (CHAMPS; Stewart et al., 2001)
    Description
    Change in participants' self-reported physical activity levels across baseline (week 0), and post-intervention (week 4). CHAMPS measures the average number of hours individuals report engaging in 41 different activities (or varying intensities) during a typical week. Metabolic equivalent of task (MET) scores are calculated for activities engaged in at mild, moderate and vigorous intensity with higher scores indicating higher levels of engagement.
    Time Frame
    Baseline (week 0), post-intervention (week 4)
    Title
    Lower body strength: Sit-to-Stand test (Bohannon, 1995)
    Description
    Change in participants' objective performance on the sit-to-stand test across baseline (week 0), and post-intervention (week 4). The sit-to-stand test measures lower body strength by recording the maximum number of times an individual can go from a seated position to a standing position, without using their arms, in a 30-second period.
    Time Frame
    Baseline (week 0), post-intervention (week 4)
    Title
    Nutritional status: body weight loss, serum albumin, hand grip strength, body mass index, lean body mass and percentage of body fat
    Description
    Change in nutritional status across baseline (week 0), and post-intervention (week 4). Body mass index (kg/m2), lean body mass and percentage of body fat will be measured using a bioimpedance machine. Self-reported body weight loss in the preceding three months will be recorded. Serum albumin will be measured via blood draw.
    Time Frame
    Baseline (week 0), post-intervention (week 4)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently aged 18 years or older Diagnosed with non-metastatic, colorectal cancer Awaiting resection of malignant colorectal lesions Able to provide informed consent in English or in French Exclusion Criteria: - Have health condition(s) interfering with ability to safely perform exercise at home or to complete testing procedures (e.g., non-ambulatory, dementia, severe end-organ disease, morbid obesity, cardiac abnormalities)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franco Carli, MD
    Organizational Affiliation
    McGill University Health Centre/Research Institute of the McGill University Health Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    6880820
    Citation
    Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    Results Reference
    background
    PubMed Identifier
    8275167
    Citation
    Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
    Results Reference
    background
    PubMed Identifier
    11445760
    Citation
    Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.
    Results Reference
    background
    PubMed Identifier
    12890299
    Citation
    Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
    Results Reference
    background
    PubMed Identifier
    15273542
    Citation
    Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
    Results Reference
    background
    PubMed Identifier
    7624188
    Citation
    Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
    Results Reference
    background

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    Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.

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