Clinical trial NCT00737230: Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis
Official title: Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-08-18
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: 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:
measure: Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year
measure: Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year
measure: 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
measure: Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year
measure: Cost-effectiveness of nurse practitioner delivery of algorithm compared to gastroenterologist as measured by the ED-5D questionnaire at 6 months and 1 year
measure: Other unmet healthcare needs as a direct result of pelvic radiotherapy
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden - London
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Jervoise Andreyev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.