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

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ClinicalTrials.gov Identifier: NCT03998579
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Maria Hagströmer, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Bladder Cancer Other: The CanMoRe programme Other: Home exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer - the CanMoRe Study
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 20, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998579


Contacts
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Contact: Andrea Porserud, MSc +46736839140 andrea.porserud@ki.se
Contact: Markus Aly, PhD +4685177000 markus.aly@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Andrea Porserud, MSc    +46736839140    andrea.porserud@ki.se   
Contact: Patrik Karlsson, MSc    +46739655642    patrik.karlsson@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Principal Investigator: Maria Hagstromer, PhD Karolinska Institutet
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Hagströmer, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03998579    
Other Study ID Numbers: 2012/2214-31/4
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases