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NCT00895388 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00895388
Other study ID # P REK NORD 105/2007
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2009
Est. completion date December 2, 2019

Study information
Verified date November 2011
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2, 2019
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Structured Rehabilitation program
Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation

Locations
Country Name City State
Norway Dep. of gastrointestinal surgery, University Hospital of North Norway Tromsø

Sponsors (2)
Lead Sponsor Collaborator
University Hospital of North Norway Helse Nord

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38) Baseline, 3, 6, 12,18 and 24 months postoperative.
Primary Quality of LIfe (EQ 5D) Baseline, 3,6,12, 18 and 24.
Secondary St Marks incontinence Baseline, 3, 12 and 24
Secondary ICIQ sexual function baseline, 3,12 and 24
Secondary ICIQ Urinary function Short form baseline,3, 12 and 24 months
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