Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer (CanMoRe)
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|ClinicalTrials.gov Identifier: NCT03998579|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder Cancer||Other: The CanMoRe programme Other: Home exercise||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer - the CanMoRe Study|
|Estimated Study Start Date :||August 19, 2019|
|Estimated Primary Completion Date :||June 20, 2021|
|Estimated Study Completion Date :||June 20, 2022|
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
- 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.
- ActivPAL accelerometer [ Time Frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention, ]Habitual physical activity, measured for 7 consecutive days. Output: number of steps per day.
- Chair stand test [ Time Frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention, ]Measure of leg strength. Output: Scale 0-30
- Hand grip strength [ Time Frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention, ]Measure of hand grip strength (Jamar hand dynamometer). Output: Kilo 0-60
- 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 ]Health related quality of life. Output: Scale 0-100. A higher score is worse outcome. For more information see https://qol.eortc.org/questionnaires/
- EORTC QLQ-BLM30 [ Time Frame: Measurement 1: Baseline Measurement 2: After 12 weeks intervention ]Health related quality of life specific for bladder cancer Output: Scale 0-100, a higher score is worse
- Piper Fatigue Scale [ Time Frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention ]Fatigue. Output: Scale 0-10. A higher score is worse, i.e more fatigue
- Numeric rating scale (NRS) [ Time Frame: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention ]Pain. Output: Scale 0-10, A higher score is worse i.e more pain
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Measurement 1: Baseline, Measurement 2: 12 weeks ]Psychological wellbeing. Output: Scale 0-21. A higher score is worse
- Readmission [ Time Frame: Collected from journals using standardized time frames at 30 and 90 days ]Readmissions to hospital. Output: Yes/No
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998579
|Contact: Andrea Porserud, MScfirstname.lastname@example.org|
|Contact: Markus Aly, PhDemail@example.com|
|Principal Investigator:||Maria Hagstromer, PhD||Karolinska Institutet|