Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care

Bladder Cancer Clinical Trial

— TPC-RCT  

Official title:

Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03347045
• Other study ID #: 2017CRIF-JMARTYN
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: November 16, 2017
• Start date: January 15, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: November 2017
• Source: Alberta Health Services, Calgary
• Contact: Jason Martyn, MScPT
• Phone: 403-943-3575
• Email: jason.martyn[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Nutrition Aspect of Cancer
• Urinary Bladder Neoplasms

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Jason Martyn	Alberta Health Services, Physiotherapy Alberta - College + Association, University of Alberta, University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay (LOS)	Length of stay in the hospital starting from post-operative day #0 and terminating when the participant is discharged from the hospital.	Collected at the finale of participant-involvement (20-weeks)
Other	30 day readmission rate	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.	Collected at the finale of participant-involvement (20-weeks)
Other	Clavien-Dindo classification of Surgical Complications	A classification scheme that objectively grades surgical complications using a descriptive grading system.	Collected at the finale of participant-involvement (20-weeks)
Primary	6-minute walk test (6MWT)	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.	Multiple time-points over 20-weeks
Secondary	10-meter walk test (10mWT)	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.	Multiple time-points over 20-weeks
Secondary	30s sit-to-stand test (30CST)	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.	Multiple time-points over 20-weeks
Secondary	Hand-grip dynamometry	A quantitative and objective measure of isometric muscular strength of the hand and forearm, predictive of overall upper-extremity function.	Multiple time-points over 20-weeks
Secondary	Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire	A reliable and valid questionnaire that comprehensively assesses quality of life concerns pertinent to bladder cancer patients.	Collected at beginning and end of 20-week participant involvement period
Secondary	EuroQOL five dimensions (EQ-5D) Questionnaire	A short, generic quality of life questionnaire	Collected at beginning and end of 20-week participant involvement period
Secondary	Godin Leisure Time Exercise Questionnaire	A short questionnaire on self-reported physical activity.	Collected at beginning and end of 20-week participant involvement period