Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care (TPC-RCT)

• ClinicalTrials.gov Identifier: NCT03347045
• Recruitment Status: Unknown
• First Posted: November 20, 2017
• Last Update Posted: November 20, 2017
• Sponsor: Jason Martyn
• Collaborators: Alberta Health Services; University of Calgary; Physiotherapy Alberta - College + Association; University of Alberta
• Information provided by (Responsible Party): Jason Martyn, Alberta Health Services, Calgary

Study Description

Brief Summary:

Trimodal prehabilitation is a preoperative three-tiered (trimodal) approach to optimizing physical and mental health. It has been found to successfully improve functional recovery in patients undergoing colorectal surgery following an evidence-based enhanced-recovery pathway (ERP). It is unknown whether the same program is effective in patients undergoing a similar surgery for bladder cancer (radical cystectomy).

Objective: To evaluate the appropriateness of a standardized prehabilitation program for implementation into an enhanced recovery pathway for cystectomy patients and determine whether prehabilitation facilitates earlier recovery of functional capacity.

Hypothesis: Prehabilitation will ultimately improve recovery of functional capacity, clinical and patient-centered outcomes in patients undergoing radical cystectomy for bladder cancer.

Design: Participants will follow an 8-week trimodal prehabilitation program consisting of exercise therapy combined with nutritional counseling, protein supplementation, and psychological care; they will be compared to a cohort of participants following ERP care alone.

Conclusion: The proposal will provide insight into the feasibility and effectiveness of trimodal prehabilitation for radical cystectomy patients and may ultimately lead to improved clinical outcomes and reduced morbidity.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer; Nutrition Aspect of Cancer	Combination Product: Trimodal Prehab & ERP; Other: No Prehab; ERP Alone	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-center pragmatic randomized-control trial.
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessor blinding; due to the nature of the study, participant, care provider & investigator cannot be blinded.
• Primary Purpose: Treatment
• Official Title: Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care: A Randomized Control Trial
• Estimated Study Start Date: January 15, 2018
• Estimated Primary Completion Date: January 15, 2019
• Estimated Study Completion Date: July 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Trimodal Prehab & ERP; Trimodal prehab includes: Guided exercise program at Repsol Place in Calgary, Alberta 2x/week, hosted by the Total Cardiology group. Home-exercise program for another 3x/week.; Nutritional optimization with a high-protein oral supplement, along with nutritional counseling and access to a Registered Dietitian on site.; Anxiety reduction workshop and take-home anxiety reduction program.	Combination Product: Trimodal Prehab & ERP; 1-hr daily exercise will be completed a total of 5d/week, of which 2 of these sessions are completed through a community fitness center. Following these sessions, the participant will consume a high-protein oral supplement. Additionally, during the program, participants will be given the option of attending a stress-reduction group and will receive a take-home anxiety-reduction program. They will have access to a physiotherapist, kinesiologist, registered dietitian, and physician throughout the program. The total length of this program is 8-weeks and is timed to occur in the waiting period between the consent for surgery and operation date.; Other Name: Trimodal prehab and enhanced-recovery pathway (ERP) together
Active Comparator: No Prehab; ERP Alone; The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.	Other: No Prehab; ERP Alone; 1-hr daily exercise with a self-completed home-exercise program. The participant will be given nutritional education material and a take-home anxiety-reduction program. They will be responsible for maintaining a journal of their activity.; Other Name: No trimodal prehab; enhanced-recovery pathway (ERP) alone

Outcome Measures

Primary Outcome Measures :

1. 6-minute walk test (6MWT) [ Time Frame: Multiple time-points over 20-weeks ]
   The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Secondary Outcome Measures :

1. 10-meter walk test (10mWT) [ Time Frame: Multiple time-points over 20-weeks ]
   The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
2. 30s sit-to-stand test (30CST) [ Time Frame: Multiple time-points over 20-weeks ]
   The 30CST is a measurement that assesses functional lower extremity strength in older adults. It is part of the Fullerton Functional Fitness Test Battery. This test was developed to overcome the floor effect of the 5 or 10 repetition sit to stand test in older adults.
3. Hand-grip dynamometry [ Time Frame: Multiple time-points over 20-weeks ]
   A quantitative and objective measure of isometric muscular strength of the hand and forearm, predictive of overall upper-extremity function.
4. Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire [ Time Frame: Collected at beginning and end of 20-week participant involvement period ]
   A reliable and valid questionnaire that comprehensively assesses quality of life concerns pertinent to bladder cancer patients.
5. EuroQOL five dimensions (EQ-5D) Questionnaire [ Time Frame: Collected at beginning and end of 20-week participant involvement period ]
   A short, generic quality of life questionnaire
6. Godin Leisure Time Exercise Questionnaire [ Time Frame: Collected at beginning and end of 20-week participant involvement period ]
   A short questionnaire on self-reported physical activity.

Other Outcome Measures:

1. Length of hospital stay (LOS) [ Time Frame: Collected at the finale of participant-involvement (20-weeks) ]
   Length of stay in the hospital starting from post-operative day #0 and terminating when the participant is discharged from the hospital.
2. 30 day readmission rate [ Time Frame: Collected at the finale of participant-involvement (20-weeks) ]
   Number of participants re-admitted to hospital within 30 days of discharge as a percentage of the total number of participants involved in the study.
3. Clavien-Dindo classification of Surgical Complications [ Time Frame: Collected at the finale of participant-involvement (20-weeks) ]
   A classification scheme that objectively grades surgical complications using a descriptive grading system.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or female ≥ 18 years of age at time of consent for surgery.
2. Documentation of bladder cancer diagnosis as evidenced by diagnostic imaging and biopsy.
3. May or may not receive adjuvant therapy.
4. Written informed consent obtained from subject

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or adherence to the program. This includes:

   1. American Society of Anesthesiologists (ASA) health class status 4-5;
   2. Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
   3. Severe cardiac abnormalities, end-stage organ disease, sepsis, or morbid obesity (BMI greater than 35);
2. Undergoing radical cystectomy for a reason other than bladder cancer.
3. Poor comprehension of English or French
4. Screened by Total Cardiology staff and determined to be inappropriate for prehabilitation at their facility.

Contacts and Locations

Contacts

Contact: Jason Martyn, MScPT; 403-943-3575; jason.martyn@ahs.ca

Contact: Chelsia Gillis, PhD; chelsia.gillis@ucalgary.ca

Sponsors and Collaborators

Jason Martyn

Alberta Health Services

University of Calgary

Physiotherapy Alberta - College + Association

University of Alberta

Investigators

• Principal Investigator: Jason Martyn, MScPT; Alberta Health Services

  Study Documents (Full-Text)

Documents provided by Jason Martyn, Alberta Health Services, Calgary:

Study Protocol  [PDF] November 11, 2017

More Information

• Responsible Party: Jason Martyn, Physiotherapist, Alberta Health Services, Calgary
• ClinicalTrials.gov Identifier: NCT03347045
• Other Study ID Numbers: 2017CRIF-JMARTYN
• First Posted: November 20, 2017
• Last Update Posted: November 20, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason Martyn, Alberta Health Services, Calgary:

cystectomy; nutrition; physiotherapy; prehabilitation; enhanced recovery after surgery

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases