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

Royal Marsden NHS Foundation Trust250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Enrollment

250

Conditions

Cancer

Interventions

educational interventionOTHER

questionnaire administrationOTHER

assessment of therapy complicationsPROCEDURE

gastrointestinal complications management/prevention

Eligibility

Sex: ALL

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * 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

Locations (1)

Royal Marsden - London

London, England, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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