Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis
NCT ID: NCT00737230
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2007-04-30
2012-07-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying the care of cancer patients with bowel injury caused by radiation therapy to the pelvis.
Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
HEALTH_SERVICES_RESEARCH
Interventions
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educational intervention
questionnaire administration
assessment of therapy complications
gastrointestinal complications management/prevention
management of therapy complications
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Has undergone radical pelvic radiotherapy with curative intent to the prostate, bladder, vulva, vagina, cervix, endometrium, anus, or rectum OR para-aortic irradiation for a tumor at any of these primary sites, including the testes, \> 6 months ago
* Has new-onset, troublesome gastrointestinal symptoms that developed \> 6 months after completion of pelvic radiotherapy
* Does not require immediate gastroenterological assessment, as deemed by the clinical oncologist
* Recruited directly from radiotherapy follow-up clinics at the Royal Marsden Hospital
PATIENT CHARACTERISTICS:
* Life expectancy \> 1 year
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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Jervoise Andreyev, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden - London
London, England, United Kingdom
Countries
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References
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Andreyev HJ, Benton BE, Lalji A, Norton C, Mohammed K, Gage H, Pennert K, Lindsay JO. Algorithm-based management of patients with gastrointestinal symptoms in patients after pelvic radiation treatment (ORBIT): a randomised controlled trial. Lancet. 2013 Dec 21;382(9910):2084-92. doi: 10.1016/S0140-6736(13)61648-7. Epub 2013 Sep 23.
Other Identifiers
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RMNHS-CCR2918-ORBIT
Identifier Type: -
Identifier Source: secondary_id
EU-20868
Identifier Type: -
Identifier Source: secondary_id
CDR0000601214
Identifier Type: -
Identifier Source: org_study_id