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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00737230
First received: August 15, 2008
Last updated: August 23, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention
Cancer
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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Health Services Research
Official Title: Effective Management of Radiation-induced Bowel Injury: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life as measured by the modified IBDQ and SF-12 questionnaires at baseline, 6 months, and 1 year [ Designated as safety issue: No ]
  • Anxiety and depression scores as measured by the Hospital Anxiety and Depression Scale questionnaire at baseline, 6 months, and 1 year [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Cost-effectiveness of diagnostic tests and treatment compared to "usual care" as measured by the ED-5D questionnaire at 6 months and 1 year [ Designated as safety issue: No ]
  • Cost-effectiveness of nurse practitioner delivery of algorithm compared to gastroenterologist as measured by the ED-5D questionnaire at 6 months and 1 year [ Designated as safety issue: No ]
  • Other unmet healthcare needs as a direct result of pelvic radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2007
Study Completion Date: July 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737230

Locations
United Kingdom
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Jervoise Andreyev, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00737230     History of Changes
Other Study ID Numbers: CDR0000601214, RMNHS-CCR2918-ORBIT, EU-20868
Study First Received: August 15, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

ClinicalTrials.gov processed this record on October 16, 2014