Pediatric CancersNCT00675467
Palliative Care and Symptom Management for the Pediatric Oncology Patient
An observational study of Pediatric Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric Cancers
- What is being tested?
- Focus Group - Parent/Caregiver and Focus Group - Pediatric Patient
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study participants 10-18 years of age with cancer and their parent(s) or caregiver(s).
Who may be able to join
- 10-18 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
Show all 14Show fewer
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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:
Read more
- 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.
- 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 Objectives:
- 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 (MCACC or MDACC) based on identified needs as determined by primary study aims 1 and 2.
Read the detailed description
PARENT:
The Focus Group:
If you agree to take part in this study, you will attend a 1 1/2 hour group session with 3-9 other caregivers. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about communication, decision-making, symptom management, emotional adjustment, and spirituality experiences and needs during your child's treatment. If you have a child who is also taking part in this study, you will meet separately from your child.
At the time of your arrival and before the beginning of the focus group session, you will be asked to complete a questionnaire. You will be asked about you and your child's age, sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. You will be asked about when you found out your child had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). You will be asked whether others have shared parenting responsibilities, your education level, and if you work and what type of work you do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets maintained by the study chair. The audiotapes will be destroyed once the study and analyses are complete.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Transcribed results will have all identifiable markers removed and kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is complete once you finish the group meeting.
PEDIATRIC PARTICIPANT:
The Focus Group:
If you agree to take part in this study, you will go to a 1 1/2 hour group session with 3-9 other patients. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about who you talk with about the disease, how you make a decision, how you manage any symptoms you may have, how you are feeling about the disease, and how religion has helped you during your treatment. If your parent is also taking part in this study, you will meet separately from your parent.
At the time of your arrival and before the beginning of the focus group session, your parent will be asked to complete a questionnaire. Your parent will be asked about their age and sex, your age and sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. Your parent will be asked when they found out you had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). Your parent will be asked whether others have shared parenting responsibilities, their education level, and if they work and about the type of work they do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets taken care of by the study chair. The audiotapes will be destroyed once the study is over and the researchers have finished looking at the information.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Any personal information about you will be removed from these papers and the papers will be kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is over once you complete the focus group.
- Conditions
- Pediatric Cancers
- Being tested
- Focus Group - Parent/Caregiver, Focus Group - Pediatric Patient
- Keywords
- Pediatric Cancer, Focus Group, Pediatric cancer patients, Parents of Pediatric cancer patients, Pediatric Palliative Care Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Group - Parent/CaregiverBehavioural
A 1 1/2 hour group session with other parents/caregivers.
Focus Group - Pediatric PatientBehavioural
A 1 1/2 hour group session with other pediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Early cancer group-children ages 10-13 years Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient | |
| Group 2 | Early cancer group-children ages 14 to 18 years Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient | |
| Group 3 | Early cancer group-parents of patients ages 10-18 years Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient | |
| Group 4 | Advanced cancer group-children ages 10-13 years Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient | |
| Group 5 | Advanced cancer group-children ages 14-18 years Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient | |
| Group 6 | Advanced cancer group-parents of children ages 10-18 years Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient | |
| Group 7 | End of life group - parents of children ages birth to 18 years of age at time of death Receives: Behavioral: Focus Group - Parent/Caregiver; Behavioral: Focus Group - Pediatric Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative Care Service Needs of Pediatric Cancer Patients + Their Parents
Qualitative data collection.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda Robert, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675467
- Sponsor's protocol ID
- 2007-0054
- Status last verified
- Apr 2016
- First submitted
- 7 May 2008
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care and Symptom Management for the Pediatric Oncology Patient
- ClinicalTrials.gov ID
- NCT00675467
- Acronym / sponsor ID
- 2007-0054
- Conditions
- Pediatric Cancers
- Keywords
- Pediatric Cancer, Focus Group, Pediatric cancer patients, Parents of Pediatric cancer patients, Pediatric Palliative Care Program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2016 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 Objectives:
- 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 (MCACC or MDACC) based on identified needs as determined by primary study aims 1 and 2.
Detailed description
PARENT:
The Focus Group:
If you agree to take part in this study, you will attend a 1 1/2 hour group session with 3-9 other caregivers. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about communication, decision-making, symptom management, emotional adjustment, and spirituality experiences and needs during your child's treatment. If you have a child who is also taking part in this study, you will meet separately from your child.
At the time of your arrival and before the beginning of the focus group session, you will be asked to complete a questionnaire. You will be asked about you and your child's age, sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. You will be asked about when you found out your child had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). You will be asked whether others have shared parenting responsibilities, your education level, and if you work and what type of work you do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets maintained by the study chair. The audiotapes will be destroyed once the study and analyses are complete.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Transcribed results will have all identifiable markers removed and kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is complete once you finish the group meeting.
PEDIATRIC PARTICIPANT:
The Focus Group:
If you agree to take part in this study, you will go to a 1 1/2 hour group session with 3-9 other patients. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about who you talk with about the disease, how you make a decision, how you manage any symptoms you may have, how you are feeling about the disease, and how religion has helped you during your treatment. If your parent is also taking part in this study, you will meet separately from your parent.
At the time of your arrival and before the beginning of the focus group session, your parent will be asked to complete a questionnaire. Your parent will be asked about their age and sex, your age and sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. Your parent will be asked when they found out you had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). Your parent will be asked whether others have shared parenting responsibilities, their education level, and if they work and about the type of work they do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets taken care of by the study chair. The audiotapes will be destroyed once the study is over and the researchers have finished looking at the information.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Any personal information about you will be removed from these papers and the papers will be kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is over once you complete the focus group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientEarly cancer group-children ages 10-13 years |
| Group 2 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientEarly cancer group-children ages 14 to 18 years |
| Group 3 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientEarly cancer group-parents of patients ages 10-18 years |
| Group 4 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientAdvanced cancer group-children ages 10-13 years |
| Group 5 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientAdvanced cancer group-children ages 14-18 years |
| Group 6 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientAdvanced cancer group-parents of children ages 10-18 years |
| Group 7 | – | Behavioral: Focus Group - Parent/Caregiver, Behavioral: Focus Group - Pediatric PatientEnd of life group - parents of children ages birth to 18 years of age at time of death |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study participants 10-18 years of age with cancer and their parent(s) or caregiver(s).
Key inclusion criteria (14 listed)
- 10-18 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Group - Parent/CaregiverA 1 1/2 hour group session with other parents/caregivers. | Behavioural | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
| Focus Group - Pediatric PatientA 1 1/2 hour group session with other pediatric patients. | Behavioural | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
Primary outcome
Palliative Care Service Needs of Pediatric Cancer Patients + Their Parents
Time frame: 3 Years
Qualitative data collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Pediatric Cancers
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda Robert, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palliative Care Service Needs of Pediatric Cancer Patients + Their Parents (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.