CanMoRe: Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Six-minute walk test [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
- ActivPAL accelerometer [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.
- Chair stand test [Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge]
Measure of leg strength. Output: Scale 0-30
- Hand grip strength [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
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of life for cancer patients QLQ-C30 [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/
- EORTC QLQ-BLM30 [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
- Piper Fatigue Scale [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
- Numeric rating scale (NRS) [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
- Hospital Anxiety and Depression Scale (HADS) [Measurement 1: Baseline, Measurement 2: 12 weeks. Measurement 3: 1 year after discharge]
Psychological wellbeing. Output: Scale 0-21. A higher score is worse
- Readmission [Collected from journals using standardized time frames at 30 and 90 days]
Readmissions to hospital. Output: Yes/No
- Complications [Collected from journals using standardized time frames at 30 and 90 days]
Complications such as Pneumonia Output: according to Clavien - Dindo classification
- Six-minute walk test [Measurement 3: 1 year after discharge]
The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska University Hospital | Stockholm | Sweden | 17176 |
Sponsors and Collaborators
- Karolinska Institutet
- Karolinska University Hospital
Investigators
- Principal Investigator: Maria Hagstromer, PhD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 2012/2214-31/4