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Palliative Care and Symptom Management for the Pediatric Oncology Patient

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, May 2008

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00675467
  Purpose

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.


Condition Intervention
Pediatric Cancers
Behavioral: Focus Group - Parent/Caregiver
Behavioral: Focus Group - Pediatric Patient

MedlinePlus related topics:   Cancer    Caregivers    Palliative Care   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Palliative Care and Symptom Management for the Pediatric Oncology Patient

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   252
Study Start Date:   April 2008
Estimated Primary Completion Date:   April 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
Group 1
Early cancer group-children ages 10-13 years
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.
Group 2
Early cancer group-children ages 14 to 18 years
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.
Group 3
Early cancer group-parents of patients ages 10-18 years
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.
Group 4
Advanced cancer group-children ages 10-13 years
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.
Group 5
Advanced cancer group-children ages 14-18 years
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.
Group 6
Advanced cancer group-parents of children ages 10-18 years
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.
Group 7
End of life group - parents of children ages birth to 18 years of age at time of death
Behavioral: Focus Group - Parent/Caregiver
A 1 1/2 hour group session with other parents/caregivers.
Behavioral: Focus Group - Pediatric Patient
A 1 1/2 hour group session with other pediatric patients.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

Children 10-18 years of age with cancer and their parent(s) or caregiver(s).


Criteria

Inclusion Criteria:

Inclusion for Children:

  • 10-18 yrs of age
  • MCACC cancer patient
  • receiving anti-cancer treatment for disease that is not recurrent or metastatic for cancer diagnosed in the past 3-12 mos or receiving anti-cancer treatment for recurrent or metastatic cancer diagnosed within the past 3-12 months
  • speak & understand English
  • reside in the Greater Houston area
  • provide IRB-approved pediatric assent or informed consent, as age appropriate
  • if < 18 yrs of age, provide IRB-approved parental permission
  • child's eligibility is not contingent upon parent's decision to participate

Inclusion for parents:

  • 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 (0-18 yrs of age at time of death) treated for cancer at MCACC who has died in the last 1 to 2 years
  • speak and understand English
  • reside in the Houston metropolitan area
  • provide IRB-approved informed consent
  • attend different focus groups if more than one eligible parent per child (max 2 parents per child)
  • parent's eligibility is not contingent upon the child's decision to participate

Exclusion Criteria:

Exclusion for Children:

  • 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
  • younger than 10 years or older than 18 years of age

Exclusion for Caregiver:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675467

Contacts
Contact: Rhonda Robert, PhD     713-792-6620    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Rhonda Robert, PhD            

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Rhonda Robert, PhD     U.T. M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T. M.D. Anderson Cancer Center ( Rhonda Robert, PhD/Associate Professor )
Study ID Numbers:   2007-0054
First Received:   May 7, 2008
Last Updated:   May 8, 2008
ClinicalTrials.gov Identifier:   NCT00675467
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Pediatric Cancer  
Focus Group  

ClinicalTrials.gov processed this record on October 23, 2008




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