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

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ClinicalTrials.gov Identifier: NCT00895388
Recruitment Status : Unknown
Verified November 2011 by University Hospital of North Norway.
Recruitment status was:  Recruiting
First Posted : May 8, 2009
Last Update Posted : November 3, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Quality of Life Sexual Function Urinary Incontinence Anal Incontinence Behavioral: Structured Rehabilitation program

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2009
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Structured Rehabilitation program Behavioral: Structured Rehabilitation program
Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation
No Intervention: Controls


Outcome Measures

Primary Outcome Measures :
  1. Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38) [ Time Frame: Baseline, 3, 6, 12,18 and 24 months postoperative. ]
  2. Quality of LIfe (EQ 5D) [ Time Frame: Baseline, 3,6,12, 18 and 24. ]

Secondary Outcome Measures :
  1. St Marks incontinence [ Time Frame: Baseline, 3, 12 and 24 ]
  2. ICIQ sexual function [ Time Frame: baseline, 3,12 and 24 ]
  3. ICIQ Urinary function Short form [ Time Frame: baseline,3, 12 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00895388     History of Changes
Other Study ID Numbers: P REK NORD 105/2007
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Rectal Neoplasms
Urinary Incontinence
Enuresis
Fecal Incontinence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders