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Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin

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ClinicalTrials.gov Identifier: NCT00502177
Recruitment Status : Active, not recruiting
First Posted : July 17, 2007
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2009-0528, "A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas".

Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally. It is hypothesized that physical health and functioning concerns, as reported by parent/child dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0 Generic Core Scales, will will remain stable or improve, following the surgical procedures and peritoneal perfusion described in Protocol 2009-0528.

Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be beneficial across time, despite the temporary postoperative pain and discomfort that is associated with the procedure. This will be done by means of a non-validated question that is specific to the surgery.

Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II chemotherapy agents and/or palliative radiation, and comparing quality of life in these subgroups will be of value. Also the quality of life for groups of patients enrolled in Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.


Condition or disease Intervention/treatment
Peritoneal Neoplasms Behavioral: Questionnaire

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
Actual Study Start Date : June 2007
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Cisplatin
U.S. FDA Resources

Group/Cohort Intervention/treatment
Quality of Life Questionnaire
Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
Behavioral: Questionnaire
QOL Questionnaires taking a total of 10 minutes to complete.
Other Name: Survey



Primary Outcome Measures :
  1. PedsQL 4.0 Generic Core Scale [ Time Frame: 6 Months ]
    The mean change in PedsQL 4.0 Generic Core Total Score over time (i.e., prior to operation vs. 6-months post-operation. The PedsQL 4.0 Generic Core will be administered to each child to ascertain their quality of life at the two time points).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
Criteria

Inclusion Criteria

  1. All participants must be English or Spanish speaking.
  2. A patient enrolled on Protocol 2009-0528, and/or one parent or adult non-parent primary caretaker of the child enrolled on Protocol 2009-0528.
  3. Patients greater than or equal to 1 year.

Exclusion Criteria:

  1. Patients not enrolled on Protocol 2009-0528 will be excluded from this study.
  2. Patients less than 1 year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502177


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Andrea Hayes-Jordan, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502177     History of Changes
Other Study ID Numbers: 2006-1106
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Continuous Hyperthermic Peritoneal Perfusion
Peritoneal Neoplasms
Quality of Life
Questionnaire
Survey
CHPP

Additional relevant MeSH terms:
Fever
Peritoneal Neoplasms
Body Temperature Changes
Signs and Symptoms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cisplatin
Antineoplastic Agents