Back to resultsEffects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial
Primary Purpose
Quality of Life, Sexual Function, Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Structured Rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Quality of Life focused on measuring Urinary function, Anal function
Eligibility Criteria
Inclusion Criteria:
- Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients
Exclusion Criteria:
- Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
Sites / Locations
- Dep. of gastrointestinal surgery, University Hospital of North Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Structured Rehabilitation program
Controls
Arm Description
Outcomes
Primary Outcome Measures
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)
Quality of LIfe (EQ 5D)
Secondary Outcome Measures
St Marks incontinence
ICIQ sexual function
ICIQ Urinary function Short form
Full Information
NCT ID
NCT00895388
First Posted
May 7, 2009
Last Updated
December 2, 2019
Sponsor
University Hospital of North Norway
Collaborators
Helse Nord
1. Study Identification
Unique Protocol Identification Number
NCT00895388
Brief Title
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial
Official Title
Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Helse Nord
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Sexual Function, Urinary Incontinence, Anal Incontinence
Keywords
Urinary function, Anal function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured Rehabilitation program
Arm Type
Other
Arm Title
Controls
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Structured Rehabilitation program
Intervention Description
Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation
Primary Outcome Measure Information:
Title
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)
Time Frame
Baseline, 3, 6, 12,18 and 24 months postoperative.
Title
Quality of LIfe (EQ 5D)
Time Frame
Baseline, 3,6,12, 18 and 24.
Secondary Outcome Measure Information:
Title
St Marks incontinence
Time Frame
Baseline, 3, 12 and 24
Title
ICIQ sexual function
Time Frame
baseline, 3,12 and 24
Title
ICIQ Urinary function Short form
Time Frame
baseline,3, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients
Exclusion Criteria:
Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolv-Ole Lindsetmo, MD, Phd, Mph
Organizational Affiliation
Dep of gastrointestinal surgery, University Hospital of North Norway
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of gastrointestinal surgery, University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
N-9037
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial
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