Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer (CanMoRe)

The Effect of Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer - the CanMoRe Study

The main objective of the CanMoRe study is to evaluate the impact of a standardized and individually adapted exercise intervention in Primary Health Care aiming at improving physical function (primary outcome) and habitual physical activity, health related quality of life, fatigue and psychological well-being in patients undergoing radical cystectomy due to urinary bladder cancer.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Cancer
• Intervention / Treatment: Other: The CanMoRe programme; Other: Home exercise

Detailed Description

The most common treatment for solid cancer tumours is surgery, often in combination with chemo- and/or radiotherapy. To minimise the postoperative complications is important in today's health care. Early mobilisation at the ward and physical activity at home after discharge, have been shown to be important parts to reduce complications. Common complications after abdominal surgery are postoperative pulmonary complications and venous thrombosis. One of the conditions that suffers the most from different kinds of postoperative complications is radical cystectomy due to urinary bladder cancer. Complications after radical cystectomy could be direct related to the patients' high age and also high degree of comorbidity.

There is today strong evidence that physical activity has a positive impact on health, survival and quality of life. Patients who have been treated for urinary bladder cancer are not sufficiently physical active and suffer from readmissions to hospital due to complications. Therefore, there is a need for developing and testing a physical rehabilitation programme to support patients who have a radical cystectomy, in the early postoperative period.

The CanMoRe study is a randomized controlled trial with a single-blinded design evaluating an exercise intervention in Primary Health Care as part of the CanMoRe programme. In addition, a qualitative study (interviews) on patient's experience of the programme will be conducted as well as data gathered on factors that might influence the implementation of the programme.

Then CanMoRe programme consists of preoperative information, the Activity Board used for enhanced mobilization during hospital stay, a 12-week, (1 h, 2 times/week) standardized and individually adapted exercise intervention in Primary Health Care and behavioral support for daily physical activity. The CanMoRe programme is evaluated in two steps, i.e. the in-hospital intervention using the Activity Board (published) and the exercise intervention in Primary Health Care reported herein.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who are planned for a robotic assisted laparoscopic radical cystectomy due to urinary bladder cancer at the Karolinska University Hospital Solna will be included in the trial. The patients should be able to talk and understand Swedish, live in the Stockholm County Council area and be mobile with or without walking aid.

Exclusion Criteria:

• Patients who will undergo radical cystectomy on a non-curative basis will not be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized exercise; The intervention group get a referral to physiotherapist in Primary Health Care in Stockholm County Council, close to where they live. Within the third week after discharge, the patients begin twelve weeks of biweekly exercise. The physical exercise is individually targeted aerobic and strength exercises, based on international recommendations for persons with cancer disease. The program is approved by resposible surgeons.	Other: The CanMoRe programme; An exercise intervention in Primary Health Care
Active Comparator: Active control group; Oral and written information of a home-based exercise programme and information of supportive techniques to improve physical activity	Other: Home exercise; An active control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.	Change from baseline to after 12 weeks intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ActivPAL accelerometer	Habitual physical activity, measured for 7 consecutive days. Output: number of steps per day.	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge
Chair stand test	Measure of leg strength. Output: Scale 0-30	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge
Hand grip strength	Measure of hand grip strength (Jamar hand dynamometer). Output: Kilo 0-60	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge,
European Organisation for Research and Treatment of Cancer (EORTC) Quality of life for cancer patients QLQ-C30	Health related quality of life. Output: Scale 0-100. A higher score is worse outcome. For more information see https://qol.eortc.org/questionnaires/	Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge
EORTC QLQ-BLM30	Health related quality of life specific for bladder cancer Output: Scale 0-100, a higher score is worse	Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge
Piper Fatigue Scale	Fatigue. Output: Scale 0-10. A higher score is worse, i.e more fatigue	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge
Numeric rating scale (NRS)	Pain. Output: Scale 0-10, A higher score is worse i.e more pain	Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge
Hospital Anxiety and Depression Scale (HADS)	Psychological wellbeing. Output: Scale 0-21. A higher score is worse	Measurement 1: Baseline, Measurement 2: 12 weeks. Measurement 3: 1 year after discharge
Readmission	Readmissions to hospital. Output: Yes/No	Collected from journals using standardized time frames at 30 and 90 days
Complications	Complications such as Pneumonia Output: according to Clavien - Dindo classification	Collected from journals using standardized time frames at 30 and 90 days
Six-minute walk test	The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.	Measurement 3: 1 year after discharge

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Maria Hagstromer, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Porserud A, Karlsson P, Rydwik E, Aly M, Henningsohn L, Nygren-Bonnier M, Hagstromer M. The CanMoRe trial - evaluating the effects of an exercise intervention after robotic-assisted radical cystectomy for urinary bladder cancer: the study protocol of a randomised controlled trial. BMC Cancer. 2020 Aug 26;20(1):805. doi: 10.1186/s12885-020-07140-5.

Helpful Links

• The link to the larger project to which this RCT belong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2012/2214-31/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No