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

University Hospital of North Norway

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Quality of Life Sexual Function Urinary Incontinence Anal Incontinence

Interventions

Structured Rehabilitation programBEHAVIORAL

Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dep. of gastrointestinal surgery, University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)

Time frame: Baseline, 3, 6, 12,18 and 24 months postoperative.

Quality of LIfe (EQ 5D)

Time frame: Baseline, 3,6,12, 18 and 24.

Secondary Outcomes

St Marks incontinence

Time frame: Baseline, 3, 12 and 24

ICIQ sexual function

Time frame: baseline, 3,12 and 24

ICIQ Urinary function Short form

Time frame: baseline,3, 12 and 24 months

Data from ClinicalTrials.gov

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