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

NCT00502177 | Completed

• 1 other identifier: 2006-1106
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Neoplasms

Keywords

Continuous Hyperthermic Peritoneal Perfusion; Peritoneal Neoplasms; Quality of Life; Questionnaire; Survey; CHPP

Outcome Measures

Primary Outcomes (1)

• PedsQL 4.0 Generic Core Scale

  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).

  6 Months

Study Arms (1)

Quality of Life Questionnaire

Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

QOL Questionnaires taking a total of 10 minutes to complete.

Also known as: Survey

Quality of Life Questionnaire

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.

You may qualify if:

• All participants must be English or Spanish speaking.
• 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.
• Patients greater than or equal to 1 year.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrea Hayes-Jordan, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: June 19, 2007
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (1)