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A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids and/or Narcotics


N/A
N/A
N/A
Not Enrolling
Both
Constipation, Neoplasms

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Trial Information

A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids and/or Narcotics


Children with cancer are treated with complex therapies including chemotherapy, radiation,
surgical interventions and biotherapy. Treatment with vinca alkaloids and/or narcotics
combined with significant lifestyle changes secondary to the disease process can have a
negative impact on the child's bowel elimination status. In trying to preserve the child's
health and well being, constipation can be minimized or even prevented as an unwanted side
effect of the treatments or disease condition.

Despite the widespread knowledge that constipation is prevalent in oncology patients,
evidence shows that cancer treatment plans often overlook constipation and reflect the lack
of consensus for effective assessment, treatment, and management. The research literature
provides a database for addressing particular aspects of constipation. However, few studies
address all the factors that affect bowel function and fewer still have recruited pediatric
populations.

The Constipation Assessment Scale (CAS) is a valid and reliable measure found to be
predictive of the presence and severity of constipation in the adult population, however it
has never been tested in the pediatric population. A pilot study utilizing the CAS tool in
children diagnosed with cancer will be conducted. The process for evaluating the presence
and severity of constipation and the reliability and validity of the CAS tool will be
tested. The study population will consist of inpatients and outpatients less than or equal
to 21 years old, receiving weekly vinca alkaloids and/or narcotics greater than or equal to
2 times per day for pain management. Patients will be followed for 7 days after the last
dose of vinca alkaloid and/or narcotic for a maximum of 6 weeks. Patients will be assessed
on admission for bowel function and constipation. The admission assessment will include a
nursing and nutrition assessment, review of the history and physical, and the administration
of the CAS. Subsequent assessments include nursing, nutrition, administration of the CAS,
and a patient daily bowel diary.

All patients regardless of participation in the study will be prescribed interventions based
on the bowel prophylaxis and management guidelines established by the NCI POB staff. These
guidelines were generated from validated studies, using Medline's criteria for scientific
soundness and clinical relevance, in the oncology literature as well as from the experience
of the NCI POB staff.

Inclusion Criteria


INCLUSION CRITERIA:

NCI patients less than or equal to 21 years of age

Diagnosis of histologically confirmed cancer

Receiving: weekly vinca alkaloids and/or narcotics greater than or equal to 2 times per
day (includes patient controlled analgesia, transdermal analgesic patches)

ECOG performance score of less than or equal to 2

Patients, parents, or legal guardian must be able to speak and read English

Informed consent: All patients or their legal guardians (if patient is less than 18 years
of age) must sign a document of informed consent indicating their understanding of the
purpose of this study and the risks associated with participation. Pediatric patients
less than 18 years of age will be included in all discussions. Written assent will be
obtained in children less than 18 and greater than or equal to 8 years of age. Verbal
assent will be obtained in children less than 8 years of age when possible.

EXCLUSION CRITERIA:

Unable to provide consent/assent

Patients with acute life threatening infection or bowel obstruction

Patients with inevaluable bowel function (i.e. patients with a colostomy or paralyzed
patients)

Patients previously enrolled on this study.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

020146

NCT ID:

NCT00032682

Start Date:

March 2002

Completion Date:

April 2006

Related Keywords:

  • Constipation
  • Neoplasms
  • Bowel Movement
  • Children
  • Stool
  • Symptom Management
  • Cancer
  • Constipation
  • Neoplasms
  • Constipation

Name

Location

National Institutes of Health Clinical Center (CC)Bethesda, Maryland  20892