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Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial

This study is currently recruiting participants.
Verified November 2011 by University Hospital of North Norway
Sponsor:
Collaborator:
Helse Nord
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00895388
First received: May 7, 2009
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Quality of Life
Sexual Function
Urinary Incontinence
Anal Incontinence
 Behavioral: Structured Rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38) [ Time Frame: Baseline, 3, 6, 12,18 and 24 months postoperative. ] [ Designated as safety issue: No ]
  • Quality of LIfe (EQ 5D) [ Time Frame: Baseline, 3,6,12, 18 and 24. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • St Marks incontinence [ Time Frame: Baseline, 3, 12 and 24 ] [ Designated as safety issue: No ]
  • ICIQ sexual function [ Time Frame: baseline, 3,12 and 24 ] [ Designated as safety issue: No ]
  • ICIQ Urinary function Short form [ Time Frame: baseline,3, 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: May 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Structured Rehabilitation program Behavioral: Structured Rehabilitation program
Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation
No Intervention: Controls

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895388

Contacts
Contact: Kjersti Mevik, MD +4777626000

Locations
Norway
Dep. of gastrointestinal surgery, University Hospital of North Norway Recruiting
Tromsø, Norway, N-9037
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
Investigators
Study Director: Rolv-Ole Lindsetmo, MD, Phd, Mph Dep of gastrointestinal surgery, University Hospital of North Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00895388     History of Changes
Other Study ID Numbers: P REK NORD 105/2007
Study First Received: May 7, 2009
Last Updated: November 2, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
Urinary function
Anal function

Additional relevant MeSH terms:
Urination Disorders
Rectal Neoplasms
Urinary Incontinence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013