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

Not Applicable

Withdrawn

• Conditions: Sexual Function; Urinary Incontinence; Anal Incontinence; Quality of Life
• Interventions: Behavioral: Structured Rehabilitation program

• Registration Number: NCT00895388
• Lead Sponsor: University Hospital of North Norway

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Status Verified: 2011-11
• Primary Completion: 2019-11
• Study Completion: 2019-12-02
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured Rehabilitation program	Structured Rehabilitation program	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ICIQ sexual function	baseline, 3,12 and 24
St Marks incontinence	Baseline, 3, 12 and 24
ICIQ Urinary function Short form	baseline,3, 12 and 24 months

Trial Locations

Locations (1)

Dep. of gastrointestinal surgery, University Hospital of North Norway; 🇳🇴 Tromsø, Norway