## Protocol Section
### Identification Module
**NCT ID:** NCT03998579

**Acronym:** CanMoRe

**Brief Title:** Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer

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

#### Organization Study ID Info
**ID:** 2012/2214-31/4
#### Organization
**Class:** OTHER
**Full Name:** Karolinska Institutet
### Status Module
#### Completion Date
**Date:** 2023-06-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-11

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-11-15

**Type:** ACTUAL

#### Start Date
**Date:** 2019-09-01

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2019-06-26
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-07
**Study First Submit QC Date:** 2019-06-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Karolinska University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Karolinska Institutet

#### Responsible Party

**Investigator Affiliation:** Karolinska Institutet

**Investigator Full Name:** Maria Hagströmer

**Investigator Title:** Associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Urinary Bladder Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: The CanMoRe programme

**Label:** Individualized exercise

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Home exercise

**Label:** Active control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Individualized exercise

**Description:** An exercise intervention in Primary Health Care

**Name:** The CanMoRe programme

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Active control group

**Description:** An active control group

**Name:** Home exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Six-minute walk test

**Time Frame:** Change from baseline to after 12 weeks intervention

#### Secondary Outcomes

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

**Measure:** ActivPAL accelerometer

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

**Description:** Measure of leg strength. Output: Scale 0-30

**Measure:** Chair stand test

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

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

**Measure:** Hand grip strength

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

**Description:** Health related quality of life. Output: Scale 0-100. A higher score is worse outcome. For more information see https://qol.eortc.org/questionnaires/

**Measure:** 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

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

**Measure:** EORTC QLQ-BLM30

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

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

**Measure:** Piper Fatigue Scale

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

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

**Measure:** Numeric rating scale (NRS)

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

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

**Measure:** Hospital Anxiety and Depression Scale (HADS)

**Time Frame:** Measurement 1: Baseline, Measurement 2: 12 weeks. Measurement 3: 1 year after discharge

**Description:** Readmissions to hospital. Output: Yes/No

**Measure:** Readmission

**Time Frame:** Collected from journals using standardized time frames at 30 and 90 days

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

**Measure:** Complications

**Time Frame:** Collected from journals using standardized time frames at 30 and 90 days

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

**Measure:** Six-minute walk test

**Time Frame:** Measurement 3: 1 year after discharge

### Eligibility Module

**Eligibility 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.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Karolinska University Hospital

**Zip:** 17176

#### Overall Officials

**Official 1:**

**Affiliation:** Karolinska Institutet

**Name:** Maria Hagstromer, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

#### See Also Links

**Label:** The link to the larger project to which this RCT belong

**URL:** https://ki.se/en/nvs/the-abdmore-project-2016-2020

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5030

- Name: Urinary Bladder Neoplasms

- Relevance: HIGH

- As Found: Urinary Bladder Cancer

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001749

- Term: Urinary Bladder Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
