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Study Summary
No. 2006-1106:.......Advanced Cancers; Kidney; Ovary; Pediatrics; Peritoneum; Phase I Studies; Psychosocial; Sarcoma; Solid Tumors; Surgical Procedure; Survey......Holly L. Green......Pediatrics
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Study Summary Title
Study Summary
Number:
2006-1106
Study Title:Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion with Cisplatin
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Physician New Patient Referral
Name:Holly L. GreenPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-1818
Contact us about clinical trials
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General Information
Disease Group:Advanced Cancers
Kidney
Ovary
Pediatrics
Peritoneum
Phase I Studies
Psychosocial
Sarcoma
Solid Tumors
Surgical Procedure
Survey
Supported By:N/A
Phase of Study:N/AReturn
Visit:
At 1 month, 3 months and 6 months following the HIPEC procedure, +/- 5 days.
These are already scheduled visits for Protocol 2009-0528. The questionnaires
will also be administered during the pre-operative assessment within one week
prior to HIPEC.
Treatment
Agents:
QuestionnaireHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
The HIPEC procedure entails an estimated 14 days in the hospital. The
questionnaires will mostly be administered in the outpatient clinic but if the
patient is hospitalized at the specific time point then they may be
administered as an inpatient.
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
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 cisplain 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.
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Study Status Information
Study Activation / Registration Date:06/19/2007
IRB Review and Approval Date:06/19/2007
Study Type:Behavioral
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 3 years.

Exclusion Criteria:1) Patients not enrolled on Protocol 2009-0528 will be excluded from this study.

2) Patients less than 3 years.

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Links
Registration Number: NCT00502177
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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