This study will evaluate a questionnaire for measuring constipation in children with cancer.
The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the
presence and severity of constipation in adult patients, but has not been tested in
children. The answers to the questionnaire will be used to determine the child's level of
constipation and to plan and provide appropriate care.
Patients up to 21 years of age who are enrolled in National Cancer Institute trials and are
taking weekly vinca alkaloids or narcotics twice a day or more may be eligible for this
On admission to the study, participants will undergo the following procedures:
- The child (or the child's parent) will be interviewed about the child's bowel habits.
- The results of the child's most recent physical examination related to bowel function
will be obtained from the medical record for review.
- A registered dietitian will interview the child or parent about the child's eating
During the study, participants will undergo the following procedures:
- A registered nurse will interview the child or parent about the child's bowel
movements. This will be done every other day for hospitalized children and three times
a week (by phone) for outpatients.
- The child or parent will complete a daily diary of bowel movements.
- A registered dietitian will evaluate the child's nutritional status periodically (by
Children who are not constipated when they enter the study will receive a stool softener
every day to prevent constipation. Children who become constipated during the study will be
treated as needed. Patients will be followed for 7 days after the last dose of vinca
alkaloid or narcotic for a maximum of 6 weeks.
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
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.
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.
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 previously enrolled on this study.