Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- PedsQL 4.0 Generic Core Scale
Study Overview
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.
Detailed Description
Child Participant:
Study Participation:
If you agree to take part in this study, you will complete questionnaires about your quality of life. If you do not want to participate in this study, your parent or caregiver may still participate and complete the parent/caregiver questionnaires if he/she chooses.
The questionnaires will ask about your experiences with pain, nausea, anxiety, worry, thinking and reasoning ability, physical appearance, communication, and your emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total, or longer if you need more time. You will also be asked about whether you worry about the surgery being effective.
If you are 4 years old or younger, your parent/caregiver will fill out the questionnaires for you.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients not enrolled on Protocol 2009-0528 will be excluded from this study.
- •Patients less than 1 year.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported