Skip to main content
OpenTrials
Completed

NCT Number: NCT03998579

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The CanMoRe programme

Other

An exercise intervention in Primary Health Care

Home exercise

Other

An active control group

Primary outcomes

  1. Six-minute walk test

    Time frame: Change from baseline to after 12 weeks intervention

    The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.

Secondary outcomes

  1. ActivPAL accelerometer

    Time frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

    Habitual physical activity, measured for 7 consecutive days. Output: number of steps per day.

  2. Chair stand test

    Time frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

    Measure of leg strength. Output: Scale 0-30

  3. Hand grip strength

    Time frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge,

    Measure of hand grip strength (Jamar hand dynamometer). Output: Kilo 0-60

  4. European Organisation for Research and Treatment of Cancer (EORTC) Quality of life for cancer patients QLQ-C30

    Time frame: Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

    Health related quality of life. Output: Scale 0-100. A higher score is worse outcome. For more information see https://qol.eortc.org/questionnaires/

  5. EORTC QLQ-BLM30

    Time frame: Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

    Health related quality of life specific for bladder cancer Output: Scale 0-100, a higher score is worse

  6. Piper Fatigue Scale

    Time frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

    Fatigue. Output: Scale 0-10. A higher score is worse, i.e more fatigue

  7. Numeric rating scale (NRS)

    Time frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

    Pain. Output: Scale 0-10, A higher score is worse i.e more pain

  8. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Measurement 1: Baseline, Measurement 2: 12 weeks. Measurement 3: 1 year after discharge

    Psychological wellbeing. Output: Scale 0-21. A higher score is worse

  9. Readmission

    Time frame: Collected from journals using standardized time frames at 30 and 90 days

    Readmissions to hospital. Output: Yes/No

  10. Complications

    Time frame: Collected from journals using standardized time frames at 30 and 90 days

    Complications such as Pneumonia Output: according to Clavien - Dindo classification

  11. Six-minute walk test

    Time frame: Measurement 3: 1 year after discharge

    The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Acronym: CanMoRe

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jun 26, 2019
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.