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

NCT03998579 | Completed

• 1 other identifier: 2012/2214-31/4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• ActivPAL accelerometer

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

• Chair stand test

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

• Hand grip strength

  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

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

• EORTC QLQ-BLM30

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

Study Arms (2)

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.

Other: The CanMoRe programme

Active control group

ACTIVE COMPARATOR

Oral and written information of a home-based exercise programme and information of supportive techniques to improve physical activity

Other: Home exercise

Interventions

The CanMoRe programme OTHER

An exercise intervention in Primary Health Care

Individualized exercise

Home exercise OTHER

An active control group

Active control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (3)

• 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.

  PMID: 32842975 BACKGROUND

• 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.

  PMID: 39692276 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.

  PMID: 39048933 DERIVED

Related Links

• The link to the larger project to which this RCT belong

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Maria Hagstromer, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 26, 2019
• Study Start: September 1, 2019
• Primary Completion: November 15, 2022
• Study Completion: June 20, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)