NCT00737230

Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis

Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: A step-by-step procedure may help health care practitioners diagnose and treat cancer patients with bowel injury symptoms caused by radiation therapy. PURPOSE: This randomized clinical trial is studying the care of cancer patients with bowel injury caused by radiation therapy to the pelvis.

Detailed description

OBJECTIVES: * To undertake a systematic review of the published effectiveness of investigations and treatments for patients with radiation-induced bowel injury after pelvic radiotherapy for cancer. * To develop a diagnostic and treatment algorithm (based on evidence \[where available\] or on expert opinion \[where there is no evidence\]) for these patients. * To examine each test in the algorithm for its usefulness in establishing precise diagnoses for these patients within the context of a randomized clinical trial. * To examine whether use of the treatment algorithm in delivering treatment specifically targeted for each diagnosis improves symptoms and quality of life of these patients. * To investigate whether the same level of care can be delivered to these patients by a nurse practitioner or by a specialist consultant gastroenterologist following the same algorithm. * To identify other symptoms and healthcare needs experienced by these patients after pelvic radiotherapy and whether there are any other unmet needs in addition to their bowel injury. * To determine the cost-effectiveness of the investigations and treatments developed for these patients. OUTLINE: This is a two-part, multicenter study. * Part 1: Researchers develop a diagnostic and treatment algorithm to guide health care practitioners in the management of patients with radiation-induced bowel injury. The algorithm, which is based on a systematic literature review or expert opinion, uses a series of simple tests to establish specific diagnoses and to target treatment for managing patient symptoms. * Part 2: Patients are stratified according to tumor site (urological vs gynecological vs gastrointestinal) and degree of bowel dysfunction as measured by IBDQ-B score \> 10 points above normal \[\< 60 vs 60-70\]). Patients are randomized to 1 of 3 intervention arms. * Arm I (usual care): Patients receive an advice booklet on self-management of bowel symptoms. Patients whose symptoms continue 6 months after study enrollment may cross over to arm II. * Arm II: Patients undergo diagnostic and treatment algorithm-led management of bowel symptoms by a gastroenterologist. * Arm III: Patients undergo diagnostic and treatment algorithm-led management of bowel symptoms by a nurse practitioner. Patients complete questionnaires about bowel symptoms and other pelvic symptoms, quality of life, and anxiety and depression at baseline, 6 months, and 1 year. Patients also complete questionnaires about cost effectiveness of the diagnostic and treatment algorithm or usual care.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	educational intervention
OTHER	questionnaire administration
PROCEDURE	assessment of therapy complications
PROCEDURE	gastrointestinal complications management/prevention
PROCEDURE	management of therapy complications
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-09-01
• Completion: 2012-07-01
• First posted: 2008-08-18
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom