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

Royal Marsden NHS Foundation Trust

Status: Completed

Conditions: Cancer

Treatments: Other: educational intervention; Procedure: management of therapy complications; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: gastrointestinal complications management/prevention; Procedure: assessment of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT00737230

RMNHS-CCR2918-ORBIT

EU-20868

CDR0000601214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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