Clinical trial NCT04248647: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Psychological prehabilitation
Colorectal cancer
Functional capacity
Physical activity
Nutrition
Psychological counselling
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Functional capacity: Six-minute walk test (Enright, 2003)
timeFrame: Baseline (week 0), post-intervention (week 4)
Secondary outcomes:
measure: Postoperative complications: Clavien Classification (Dindo, Demartines & Clavien, 2004)
timeFrame: 8-weeks post-surgery (week 12)
measure: Depressive and anxiety symptoms: The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
timeFrame: Baseline (week 0), post-intervention (week 4)
measure: Health related quality of life: RAND 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
timeFrame: Baseline (week 0), post-intervention (week 4)
measure: Physical activity: Community Health Activities Model Program for Seniors (CHAMPS; Stewart et al., 2001)
timeFrame: Baseline (week 0), post-intervention (week 4)
measure: Lower body strength: Sit-to-Stand test (Bohannon, 1995)
timeFrame: Baseline (week 0), post-intervention (week 4)
measure: Nutritional status: body weight loss, serum albumin, hand grip strength, body mass index, lean body mass and percentage of body fat
timeFrame: Baseline (week 0), post-intervention (week 4)
Other outcomes:
Locations:
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
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.
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.