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Clinical Trials/NCT04248647
NCT04248647
Completed
Not Applicable

Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection. Modalities to Mitigate the Level of Anxiety and Depression Prior to Surgery.

McGill University Health Centre/Research Institute of the McGill University Health Centre0 sites20 target enrollmentOctober 26, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
20
Primary Endpoint
Functional capacity: Six-minute walk test (Enright, 2003)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2016
End Date
April 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Franco Carli

MD

McGill University Health Centre/Research Institute 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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Nutritional status: body weight loss, serum albumin, hand grip strength, body mass index, lean body mass and percentage of body fat(Baseline (week 0), post-intervention (week 4))
  • Postoperative complications: Clavien Classification (Dindo, Demartines & Clavien, 2004)(8-weeks post-surgery (week 12))
  • Depressive and anxiety symptoms: The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)(Baseline (week 0), post-intervention (week 4))
  • Health related quality of life: RAND 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)(Baseline (week 0), post-intervention (week 4))
  • Physical activity: Community Health Activities Model Program for Seniors (CHAMPS; Stewart et al., 2001)(Baseline (week 0), post-intervention (week 4))
  • Lower body strength: Sit-to-Stand test (Bohannon, 1995)(Baseline (week 0), post-intervention (week 4))

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