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Urinary Bladder CancerCanMoReNCT03998579

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

A study testing The CanMoRe programme and Home exercise in people with Urinary Bladder Cancer, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Urinary Bladder Cancer
What is being tested?
The CanMoRe programme and Home exercise
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSweden
Study dates
1 Sep 2019to 20 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients who will undergo radical cystectomy on a non-curative basis will not be included.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: The Effect of Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer - the CanMoRe Study

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.

Read the 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.

Being tested
The CanMoRe programme, Home exercise
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The CanMoRe programmeOther

    An exercise intervention in Primary Health Care

  • Home exerciseOther

    An active control group

Study groups in NCT03998579
Study groupRoleWhat they receive
Individualized exerciseExperimentalThe 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.
Receives: Other: The CanMoRe programme
Active control groupActive comparatorOral and written information of a home-based exercise programme and information of supportive techniques to improve physical activity
Receives: Other: Home exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six-minute walk test

    The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.

    Measured: Change from baseline to after 12 weeks intervention

Secondary outcomes (11)

  1. ActivPAL accelerometer

    Habitual physical activity, measured for 7 consecutive days. Output: number of steps per day.

    Measured: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

  2. Chair stand test

    Measure of leg strength. Output: Scale 0-30

    Measured: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

  3. Hand grip strength

    Measure of hand grip strength (Jamar hand dynamometer). Output: Kilo 0-60

    Measured: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge,

  4. 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/

    Measured: Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

  5. EORTC QLQ-BLM30

    Health related quality of life specific for bladder cancer Output: Scale 0-100, a higher score is worse

    Measured: Measurement 1: Baseline Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

  6. Piper Fatigue Scale

    Fatigue. Output: Scale 0-10. A higher score is worse, i.e more fatigue

    Measured: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

  7. Numeric rating scale (NRS)

    Pain. Output: Scale 0-10, A higher score is worse i.e more pain

    Measured: Measurement 1: Baseline, Measurement 2: After 12 weeks intervention. Measurement 3: 1 year after discharge

  8. Hospital Anxiety and Depression Scale (HADS)

    Psychological wellbeing. Output: Scale 0-21. A higher score is worse

    Measured: Measurement 1: Baseline, Measurement 2: 12 weeks. Measurement 3: 1 year after discharge

  9. Readmission

    Readmissions to hospital. Output: Yes/No

    Measured: Collected from journals using standardized time frames at 30 and 90 days

  10. Complications

    Complications such as Pneumonia Output: according to Clavien - Dindo classification

    Measured: Collected from journals using standardized time frames at 30 and 90 days

  11. Six-minute walk test

    The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.

    Measured: Measurement 3: 1 year after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study start1 Sep 2019
  3. Primary completion15 Nov 2022
  4. Study completion20 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03998579
Sponsor's protocol ID
2012/2214-31/4
Acronym
CanMoRe
Status last verified
Oct 2023
First submitted
7 Jun 2019
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32842975

  • 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.

    PubMed 39692276

  • 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.

    PubMed 39048933

Questions about this trial

What is this clinical trial studying?

A study testing The CanMoRe programme and Home exercise in people with Urinary Bladder Cancer, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-minute walk test (time frame: Change from baseline to after 12 weeks intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03998579, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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