Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis
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.
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
|Study Design:||Allocation: Randomized
Primary Purpose: Health Services Research
|Official Title:||Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial|
- Improvement in gastrointestinal symptoms as measured by the modified IBDQ-B score, Rockwood Fecal Incontinence Quality of Life score, St Mark's Incontinence score, and the LENTSOMA score at baseline, 6 months, and 1 year [ Designated as safety issue: No ]
- Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year [ Designated as safety issue: No ]
- Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year [ Designated as safety issue: No ]
- Other pelvic symptoms (i.e., urinary function as measured by the ICSmaleSF and BFLUTSQ and sexual function as measured by the IIEF-6, ICSsex, and Jensen questionnaires) at baseline, 6 months, and 1 year [ Designated as safety issue: No ]
- Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year [ Designated as safety issue: No ]
- Cost-effectiveness of nurse practitioner delivery of algorithm compared to gastroenterologist as measured by the ED-5D questionnaire at 6 months and 1 year [ Designated as safety issue: No ]
- Other unmet healthcare needs as a direct result of pelvic radiotherapy [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737230
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Principal Investigator:||Jervoise Andreyev, MD||Royal Marsden NHS Foundation Trust|