MDACC Study Summary 2007-0054

Study Summary
No. 2007-0054:.......Pediatrics; Unspecified......Rhonda Robert......Pediatrics

Study Summary Title



Study Summary Number:	2007-0054

Study Title:	Palliative Care and Symptom Management for the Pediatric Oncology Patient

Physician

New Patient Referral



Name:	Rhonda Robert	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Pediatrics Unspecified	Supported By:	Children's Art Project

Phase of Study:	N/A	Return Visit:	Once for the purpose of the study.

Treatment Agents:	None	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this study is to learn about the communication, decision-making, symptom management, emotional adjustment, and spiritual needs of parents and pediatric patients treated at the Children's Cancer Hospital at M. D. Anderson.

Study Objectives / Outcomes

Primary:

1. Determine the palliative care service needs of pediatric cancer patients and their parents, including communication, decision-making, symptom management, emotional and spiritual support when receiving treatment for early cancer, treatment for advanced disease, and treatment in the end-of-life period.

2. Identify intra-group differences in the categories listed in Objective 1 for pediatric cancer patients receiving treatment (a) for early cancer, (b) for advanced disease, and (c) at end-of-life.

Secondary:

1. Inform the development of a Pediatric Palliative Care Program at the Children's Cancer Hospital at The University of Texas M. D. Anderson Cancer Center (MDACC) based on identified needs as determined by primary study aims 1 and 2.

Study Status Information



Study Activation / Registration Date:	04/10/2008

IRB Review and Approval Date:	04/10/2008

Study Type:	Observational

Recruitment Status:	Closed

Projected Accrual:	N/A

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) Inclusion for Children: 1) > or = 10 yrs of age; 2) CCH or MCACC cancer pt; 3) receiving anti-cancer treatment for disease that is not recurrent or metastatic for cancer diagnosed a minimum of 3 mos earlier or receiving anti-cancer treatment for recurrent or metastatic cancer diagnosed a minimum of 3 mos earlier; 4) speak & understand English 4) reside in Texas; 5) provide IRB-approved pediatric assent or informed consent, as age appropriate; 6) if < 18 yrs of age, provide IRB-approved parental permission; 7) child's eligibility is not contingent upon parent's decision to participate

2) Inclusion for parents: 1) self-identified parent(s) that has(have) a child eligible for study, per the inclusion and exclusion criteria noted above or has had a child treated for cancer at MCACC who has died a minimum of 1 yr earlier; 2) speak and understand English or Spanish; 3) reside in Texas; 4) provide IRB-approved informed consent; 5) parent's eligibility is not contingent upon the child's decision to participate

Exclusion Criteria:

1) Exclusion for Children:1) have cognitive impairment, developmental delay, or emotional distress that would limit participation in a group discussion, as determined by the clinical judgment of the investigator; 2) younger than 10 years or older than 18 years of age

2) Exclusion for Caregiver: 1) have cognitive impairment, developmental delay, or emotional distress that would limit participation in a group discussion, as determined by the clinical judgment of the investigator.

Links

Registration Number: NCT00675467
Study Information on Clinical Trials Registry (clinicaltrials.gov)