Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248647
• Other study ID #: MMPI/2017-2840
• Status: Completed
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: January 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Multimodal prehabilitation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

References & Publications (6)

Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. — View 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. — View Citation

Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5. Review. — View Citation

Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. — View 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. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (week 0), post-intervention (week 4)
Secondary	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.	8-weeks post-surgery (week 12)
Secondary	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.	Baseline (week 0), post-intervention (week 4)
Secondary	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.	Baseline (week 0), post-intervention (week 4)
Secondary	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.	Baseline (week 0), post-intervention (week 4)
Secondary	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.	Baseline (week 0), post-intervention (week 4)
Secondary	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.	Baseline (week 0), post-intervention (week 4)