Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032682
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-03-27
Brief Title:
Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids andor Narcotics
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs 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 study
On admission to the study participants will undergo the following procedures
The child or the childs parent will be interviewed about the childs bowel habits
The results of the childs 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 childs eating habits
During the study participants will undergo the following procedures
A registered nurse will interview the child or parent about the childs 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 childs nutritional status periodically by phone
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
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 study
On admission to the study participants will undergo the following procedures
The child or the childs parent will be interviewed about the childs bowel habits
The results of the childs 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 childs eating habits
During the study participants will undergo the following procedures
A registered nurse will interview the child or parent about the childs 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 childs nutritional status periodically by phone
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
Detailed Description:
Children with cancer are treated with complex therapies including chemotherapy radiation surgical interventions and biotherapy Treatment with vinca alkaloids andor narcotics combined with significant lifestyle changes secondary to the disease process can have a negative impact on the childs bowel elimination status In trying to preserve the childs 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 andor 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 andor 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 Medlines criteria for scientific soundness and clinical relevance in the oncology literature as well as from the experience of the NCI POB staff
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 andor 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 andor 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 Medlines criteria for scientific soundness and clinical relevance in the oncology literature as well as from the experience of the NCI POB staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CC-0146 | None | None | None |