MDACC Study Summary 2006-0829

Study Summary
No. 2006-0829:.......Pediatrics......Donna Zhukovsky......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2006-0829

Study Title:	Symptom Profiles in English and Spanish-Speaking Children with Cancer

Physician

New Patient Referral



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

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6085 Contact us about clinical trials

General Information



Disease Group:	Pediatrics	Supported By:	The American Cancer Society

Phase of Study:	N/A	Return Visit:	None

Treatment Agents:	Questionnaire	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 find out what symptoms the patient has been feeling because of his/her cancer or treatments. Researchers would also like to learn what symptoms you and the child's caregiver think that the child is having, and to try to understand any differences in how you, the caregiver, and the child feel about the child's symptoms.

Study Objectives / Outcomes

Children with cancer and Hispanics with cancer are both underserved populations that experience multiple barriers to symptom assessment and management. Access to age and language-appropriate tools, combined with a better understanding of differences in perception of the symptom experience between patients, their family care givers (fCG) and MDs, is a critical step toward improving symptom assessment and consequently, to developing improved therapeutic interventions for children with advanced cancer and their families.
1) Primary:
a) to characterize the symptom profile (frequency, intensity and associated distress) of children being treated for cancer in a pediatric oncology clinic, using 2 age-appropriate versions of the pediatric Memorial Symptom Assessment Scale (MSAS), MSAS 7-12 and MSAS 10-18 in English and Spanish.
b) to evaluate agreement of symptom assessment between child and family caregiver (fCG), between child and treating oncologist and between primary fCG and treating oncologist
c) to identify factors associated with differences in perception of the symptom experience between patient and fCGs using phenomenological interviews
2) Secondary:
a) to evaluate the usability of symptom assessment using English and Spanish-language versions of the MSAS 7-12 and MSAS 10-18
b) to describe the association between patient-assessed individual symptom scores and treatments prescribed by the physician for symptom management
c) to identify and compare the experience with symptoms of English speaking and Spanish speaking children and their fCGs

Study Status Information



Study Activation / Registration Date:	08/25/2009

IRB Review and Approval Date:	05/01/2008

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) Eligible patients will be between 7-18 years old

2) Eligible patients will have advanced cancer (relapsed or metastatic).

3) Eligible patients will be an established patient of the Division of Pediatrics (i.e. already seen as a new patient or as a consultation by the primary oncologist);

4) Eligible patients will be able to speak and understand Spanish or English.

5) Eligible patients will have an available fCG, defined as a parent or legal guardian, that speaks the same language (Spanish or English);

6) Eligible patients will give written IRB-approved informed consent or pediatric assent, with parental permission, as age-appropriate, from child;

7) Eligible patients will have written IRB-approved consent from fCG for fCG participation;

8) Eligible patients will have IRB-approved consent from physician for physician participation. However, if physician declines to participate, the patient and fCG will still be enrolled on study.

9) fCG Inclusion criteria: 1. Parent or legal guardian of child participating in study

10) fCG Inclusion criteria: 2. Speaks and understands English or Spanish

11) fCG Inclusion criteria: 3. Provides IRB-approved consent

Exclusion Criteria:

1) Patients will be excluded if their Primary MD determines there is cognitive impairment and/or psychiatric disturbance in the patient and/or family care giver, resulting in inability to complete the pediatric MSAS

2) Patients will be excluded if there is a lack of available family care giver.

3) Patients will be excluded if they have an unstable medical condition as determined by their primary physician.

4) Patients will be excluded if they have prior study participation on this protocol.

5) fCG Exclusion criteria: 1. Cognitive impairment and/or psychiatric disturbance in fCG

6) fCG Exclusion criteria: 2. Unstable medical condition

7) fCG Exclusion criteria: 3. Previous participation

Links

Registration Number: Not Applicable Clinical Trial