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

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.

Full Title of Study: “Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2019

Interventions

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

Arms, Groups and Cohorts

  • Other: Structured Rehabilitation program
  • No Intervention: Controls

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital of North Norway
  • Collaborator
    • Helse Nord
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rolv-Ole Lindsetmo, MD, Phd, Mph, Study Director, Dep of gastrointestinal surgery, University Hospital of North Norway

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