4006 776 356
免费咨询 9:00-18:00
免费获得国外相关药品，最快 1 个工作日回馈药物信息
Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer (CanMoRe)
| 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 |
| 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 |
| 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
|
- 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. Measurement 3: 1 year after discharge ]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. Measurement 3: 1 year after discharge ]Measure of leg strength. Output: Scale 0-30
- 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
- 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/
- 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
- 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
- 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
- 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
- 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
- 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.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| Contact: Andrea Porserud, MSc | +46736839140 | andrea.porserud@ki.se | |
| Contact: Markus Aly, PhD | +4685177000 | markus.aly@ki.se |
| 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 | |
| Principal Investigator: | Maria Hagstromer, PhD | Karolinska Institutet |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 7, 2019 | ||||||||
| First Posted Date ICMJE | June 26, 2019 | ||||||||
| Last Update Posted Date | March 5, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer | ||||||||
| Official Title ICMJE | The Effect of Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer - the CanMoRe Study | ||||||||
| 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. | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Urinary Bladder Cancer | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Porserud A, Karlsson P, Rydwik E, Aly M, Henningsohn L, Nygren-Bonnier M, Hagströmer 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. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 20, 2022 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Sweden | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03998579 | ||||||||
| Other Study ID Numbers ICMJE | 2012/2214-31/4 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Maria Hagströmer, Karolinska Institutet | ||||||||
| Study Sponsor ICMJE | Karolinska Institutet | ||||||||
| Collaborators ICMJE | Karolinska University Hospital | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Karolinska Institutet | ||||||||
| Verification Date | March 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
