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

Urinary Bladder Cancer Clinical Trial

— CanMoRe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998579
• Other study ID #: 2012/2214-31/4
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 20, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 20, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• The CanMoRe programme
An exercise intervention in Primary Health Care
• Home exercise
An active control group

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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,
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Readmission	Readmissions to hospital. Output: Yes/No	Collected from journals using standardized time frames at 30 and 90 days
Secondary	Complications	Complications such as Pneumonia Output: according to Clavien - Dindo classification	Collected from journals using standardized time frames at 30 and 90 days
Secondary	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

External Links

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