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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: educational intervention|nan|
|Other: questionnaire administration|nan|
|Procedure: assessment of therapy complications|nan|
|Procedure: gastrointestinal complications management/prevention|nan|
|Procedure: management of therapy complications|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long-term effects secondary to cancer therapy in adults, long-term effects secondary to cancer therapy in children, gastrointestinal complications, radiation toxicity, prostate cancer, bladder cancer, vulvar cancer, vaginal cancer, cervical cancer, endometrial cancer, anal cancer, rectal cancer, malignant testicular germ cell tumor