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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized exercise | Experimental | 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. |
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| Active control group | Active Comparator | Oral and written information of a home-based exercise programme and information of supportive techniques to improve physical activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The CanMoRe programme | Other | An exercise intervention in Primary Health Care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Chair stand test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hagstromer, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32842975 | Background | 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. | |
| 39692276 |
| Label | URL |
|---|---|
| The link to the larger project to which this RCT belong | View source |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Home exercise |
| Other |
An active control group |
|
Measure of leg strength. Output: Scale 0-30
| Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge |
| 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, |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Readmission | Readmissions to hospital. Output: Yes/No | Collected from journals using standardized time frames at 30 and 90 days |
| Complications | Complications such as Pneumonia Output: according to Clavien - Dindo classification | Collected from journals using standardized time frames at 30 and 90 days |
| 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 |
| Porserud A, Aly M, Steinertz H, Rydwik E, Hagstromer M. Exercise in primary care after robot-assisted radical cystectomy for urinary bladder cancer - effects on postoperative complications: a secondary analysis of a randomised controlled trial. Scand J Urol. 2024 Dec 18;59:193-199. doi: 10.2340/sju.v59.42589. |
| 39048933 | Derived | Porserud A, Karlsson P, Aly M, Rydwik E, Torikka S, Henningsohn L, Nygren-Bonnier M, Hagstromer M. Effects of an exercise intervention in primary care after robot-assisted radical cystectomy for urinary bladder cancer: a randomised controlled trial. BMC Cancer. 2024 Jul 24;24(1):891. doi: 10.1186/s12885-024-12647-2. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |