Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis
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|ClinicalTrials.gov Identifier: NCT00737230|
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Primary Purpose:||Health Services Research|
|Official Title:||Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||July 2012|
- 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
- Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year
- Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year
- 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
- Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year
- Cost-effectiveness of nurse practitioner delivery of algorithm compared to gastroenterologist as measured by the ED-5D questionnaire at 6 months and 1 year
- Other unmet healthcare needs as a direct result of pelvic radiotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737230
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Principal Investigator:||Jervoise Andreyev, MD||Royal Marsden NHS Foundation Trust|