NCT00675467

Brief Summary

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 (MCACC). Primary Objectives:

  1. 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

8 years

First QC Date

May 7, 2008

Last Update Submit

April 7, 2016

Conditions

Keywords

Pediatric CancerFocus GroupPediatric cancer patientsParents of Pediatric cancer patientsPediatric Palliative Care Program

Outcome Measures

Primary Outcomes (1)

  • Palliative Care Service Needs of Pediatric Cancer Patients + Their Parents

    Qualitative data collection.

    3 Years

Study Arms (7)

Group 1

Early cancer group-children ages 10-13 years

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Group 2

Early cancer group-children ages 14 to 18 years

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Group 3

Early cancer group-parents of patients ages 10-18 years

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Group 4

Advanced cancer group-children ages 10-13 years

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Group 5

Advanced cancer group-children ages 14-18 years

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Group 6

Advanced cancer group-parents of children ages 10-18 years

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Group 7

End of life group - parents of children ages birth to 18 years of age at time of death

Behavioral: Focus Group - Parent/CaregiverBehavioral: Focus Group - Pediatric Patient

Interventions

A 1 1/2 hour group session with other parents/caregivers.

Group 1Group 2Group 3Group 4Group 5Group 6Group 7

A 1 1/2 hour group session with other pediatric patients.

Group 1Group 2Group 3Group 4Group 5Group 6Group 7

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • years of age
  • MD Anderson Children's Cancer Center (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 years of age, provide Internal Review Board (IRB)-approved parental permission
  • child's eligibility is not contingent upon parent's decision to participate

You may not qualify if:

  • 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
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Rhonda Robert, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations