Cancer Clinical Trial
Official title:
Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Primary Purpose: Health Services Research
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