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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737230
• Other study ID #: CDR0000601214
• Secondary ID: RMNHS-CCR2918-OR
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: August 23, 2013
• Start date: April 2007
• Est. completion date: July 2012

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• educational intervention

• questionnaire administration

Procedure:
• assessment of therapy complications

• gastrointestinal complications management/prevention

• management of therapy complications

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year			No
Secondary	Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year			No
Secondary	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			No
Secondary	Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year			No
Secondary	Cost-effectiveness of nurse practitioner delivery of algorithm compared to gastroenterologist as measured by the ED-5D questionnaire at 6 months and 1 year			No
Secondary	Other unmet healthcare needs as a direct result of pelvic radiotherapy			No