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

March 4, 2024 updated by: University Hospital of North Norway

Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, N-9037
        • Dep. of gastrointestinal surgery, University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
St Marks incontinence
Time Frame: Baseline, 3, 12 and 24
Baseline, 3, 12 and 24
ICIQ sexual function
Time Frame: baseline, 3,12 and 24
baseline, 3,12 and 24
ICIQ Urinary function Short form
Time Frame: baseline,3, 12 and 24 months
baseline,3, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

Helse Nord

Investigators

  • Study Director: Rolv-Ole Lindsetmo, MD, Phd, Mph, Dep of gastrointestinal surgery, University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 2, 2019

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimated)

May 8, 2009

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P REK NORD 105/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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