- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04248647
Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.
Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection. Modalities to Mitigate the Level of Anxiety and Depression Prior to Surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional capacity: Six-minute walk test (Enright, 2003)
Time Frame: Baseline (week 0), post-intervention (week 4)
|
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.
|
Baseline (week 0), post-intervention (week 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications: Clavien Classification (Dindo, Demartines & Clavien, 2004)
Time Frame: 8-weeks post-surgery (week 12)
|
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.
|
8-weeks post-surgery (week 12)
|
Depressive and anxiety symptoms: The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
Time Frame: Baseline (week 0), post-intervention (week 4)
|
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.
|
Baseline (week 0), post-intervention (week 4)
|
Health related quality of life: RAND 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
Time Frame: Baseline (week 0), post-intervention (week 4)
|
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.
|
Baseline (week 0), post-intervention (week 4)
|
Physical activity: Community Health Activities Model Program for Seniors (CHAMPS; Stewart et al., 2001)
Time Frame: Baseline (week 0), post-intervention (week 4)
|
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.
|
Baseline (week 0), post-intervention (week 4)
|
Lower body strength: Sit-to-Stand test (Bohannon, 1995)
Time Frame: Baseline (week 0), post-intervention (week 4)
|
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.
|
Baseline (week 0), post-intervention (week 4)
|
Nutritional status: body weight loss, serum albumin, hand grip strength, body mass index, lean body mass and percentage of body fat
Time Frame: Baseline (week 0), post-intervention (week 4)
|
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.
|
Baseline (week 0), post-intervention (week 4)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMPI/2017-2840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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