Pediatric CancerNCT01273194
Evaluating Supportive Care for Children With Cancer: A Multi-Institutional Survey Study of Pediatric Oncology Patients and Parents
An observational study of Pediatric Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Palliative care, also known as comfort care, is intended to keep a patient comfortable by focusing on pain and symptom management to improve quality of life. Although palliative care has been demonstrated to be beneficial, it is underutilized in children who have been diagnosed with cancer, because current… Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2010to 8 Sep 2015
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pediatric Oncology Patients:
- Current patients receiving clinical care for cancer at one of the participating sites.
- At least 1 month and no more than 1 year after initial diagnosis.
- Physically and cognitively able to participate in a 30 minute interview as determined by the primary medical providers.
- Ability to understand and speak English.
- Age 10-17 at the time of first diagnosis.
Show all 12Show fewer
- Agreement of both parent and child to participate.
- Parents:
- A parent of an eligible child
- Physically and cognitively able to complete a 30 minute self-administered survey.
- Ability to read, understand and speak English.
- Agreement of both parent and child to participate.
Who cannot join
- Inability to speak English.
- Inability to understand spoken English.
- Parent s inability to read written English.
- Lack of agreement of both parent and child to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Palliative care, also known as comfort care, is intended to keep a patient comfortable by focusing on pain and symptom management to improve quality of life. Although palliative care has been demonstrated to be beneficial, it is underutilized in children who have been diagnosed with cancer, because current trends favor palliative care primarily at the end of life and in only a small number of patients. Children with cancer likely would benefit from the incorporation of palliative care from the time of diagnosis, but both doctors and families are often reluctant to include it for a variety of reasons. Researchers are interested in understanding these reasons to determine better ways to include palliative care as part of cancer treatment methods in children with cancer.
Read more
Objectives:
- To collect information on pediatric oncology patients and their parents attitudes towards palliative care, along with cancer treatment, from the time of diagnosis.
Eligibility:
- Children and adolescents between 10 and 17 years of age who have been diagnosed with cancer in the past year.
- Parents of eligible children.
Design:
- Participants will complete a 30-minute survey about experiences with pain, symptom management, and focus on quality of life in the first month following cancer diagnosis. Child participants will be asked about their views on the importance of quality of life in the beginning of their illness, as well as their attitudes toward symptom-oriented care. Parent participants will be asked questions about their child s illness, which includes understanding, discussion, and impact of illness.
- Treatment will not be provided as part of this protocol.
Read the detailed description
Background:
- Palliative care, while demonstrated to be beneficial, is underutilized in pediatric oncology.
- The current model in the U.S. favors palliative care involvement primarily at the end of life and only in a fraction of patients.
- Children with cancer likely would benefit from the incorporation of palliative care from the time of diagnosis.
- Obstacles to the incorporation of palliative care from the time of diagnosis include the possibility that the current model provides sufficient care in these areas and the possibility that families may be averse to early palliative care involvement on the grounds that it would be intrusive, detract from their goal of cure, and/or lead to a loss of hope.
- To gather data relevant to evaluating these potential obstacles, we plan to interview pediatric oncology patients and their parents to determine their views regarding provision of palliative care, along with cancer therapy, from the time of diagnosis.
Objectives:
- Primary
- To assess parent and patient attitudes toward the integration of palliative care in pediatric oncology patients from the time of diagnosis.
- To develop a survey instrument that can reliably assess the views of pediatric oncology patients and their parents with regard to patients symptom burden and management at the beginning of cancer therapy as well as attitudes toward early integration of palliative care with oncology care.
- Secondary/Specific Objectives
- To assess the degree and effect of negative symptoms in children with cancer in the beginning of cancer therapy as well as the extent to which pediatric patients symptoms and suffering at this time are being adequately managed.
- To assess the emphasis that families place on quality of life in symptom management and treatment decision making as well as the satisfaction with the degree of attention given to quality of life by the medical team.
- To assess patient and parent attitudes toward palliative care in general and receptivity toward pediatric palliative care team involvement from the time of diagnosis.
- To assess understanding of prognosis and its relationship to parent and patient attitudes toward the integration of palliative care in pediatric oncology care from the time of diagnosis.
- To assess concordance between parents and patients in their attitudes toward the integration of palliative care in pediatric oncology patients from the time of diagnosis.
Eligibility:
-Patients eligible for inclusion will be children diagnosed with an oncologic disease at least 1 month and no greater than 1 year prior with age at diagnosis of 10 to 17 years. Both patient and parent must agree to participate to be eligible for inclusion.
Design:
- Surveys will be administered to consenting patient/parent pairs with the parent completing a written survey while the patient is surveyed in the absence of the participating parent.
- Total enrollment will be a minimum of 70 subject pairs and a maximum of 110 subject pairs with a target goal of 100 subject pairs enrolled over a 6 month period.
Data collected from responses to the surveys will be analyzed at the conclusion of the survey period to assess for individual content as well as concordance between the patients and their parents.
- Conditions
- Pediatric Cancer
- Keywords
- Palliative Care, Survey, Quality of Life, Attitudes, Pediatric Cancer
- Medical subject headings
- Neoplasms, Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study start20 Dec 2010
- Study completion8 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- 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
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Wendler, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273194
- Sponsor's protocol ID
- 110063
- Other IDs
- 11-CC-0063
- Status last verified
- 8 Sep 2015
- First submitted
- 7 Jan 2011
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Harris MB. Palliative care in children with cancer: which child and when? J Natl Cancer Inst Monogr. 2004;(32):144-9. doi: 10.1093/jncimonographs/lgh007.
PubMed 15263058Gatta G, Capocaccia R, Coleman MP, Ries LA, Berrino F. Childhood cancer survival in Europe and the United States. Cancer. 2002 Oct 15;95(8):1767-72. doi: 10.1002/cncr.10833.
PubMed 12365026Wolfe J, Grier HE, Klar N, Levin SB, Ellenbogen JM, Salem-Schatz S, Emanuel EJ, Weeks JC. Symptoms and suffering at the end of life in children with cancer. N Engl J Med. 2000 Feb 3;342(5):326-33. doi: 10.1056/NEJM200002033420506.
PubMed 10655532
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Supportive Care for Children With Cancer: A Multi-Institutional Survey Study of Pediatric Oncology Patients and Parents
- ClinicalTrials.gov ID
- NCT01273194
- Acronym / sponsor ID
- 110063
- Conditions
- Pediatric Cancer
- Keywords
- Palliative Care, Survey, Quality of Life, Attitudes, Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 20 Dec 2010
- Study completion
- 8 Sep 2015
- First posted
- 10 Jan 2011 (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.
Background:
- Palliative care, also known as comfort care, is intended to keep a patient comfortable by focusing on pain and symptom management to improve quality of life. Although palliative care has been demonstrated to be beneficial, it is underutilized in children who have been diagnosed with cancer, because current trends favor palliative care primarily at the end of life and in only a small number of patients. Children with cancer likely would benefit from the incorporation of palliative care from the time of diagnosis, but both doctors and families are often reluctant to include it for a variety of reasons. Researchers are interested in understanding these reasons to determine better ways to include palliative care as part of cancer treatment methods in children with cancer.
Objectives:
- To collect information on pediatric oncology patients and their parents attitudes towards palliative care, along with cancer treatment, from the time of diagnosis.
Eligibility:
- Children and adolescents between 10 and 17 years of age who have been diagnosed with cancer in the past year.
- Parents of eligible children.
Design:
- Participants will complete a 30-minute survey about experiences with pain, symptom management, and focus on quality of life in the first month following cancer diagnosis. Child participants will be asked about their views on the importance of quality of life in the beginning of their illness, as well as their attitudes toward symptom-oriented care. Parent participants will be asked questions about their child s illness, which includes understanding, discussion, and impact of illness.
- Treatment will not be provided as part of this protocol.
Detailed description
Background:
- Palliative care, while demonstrated to be beneficial, is underutilized in pediatric oncology.
- The current model in the U.S. favors palliative care involvement primarily at the end of life and only in a fraction of patients.
- Children with cancer likely would benefit from the incorporation of palliative care from the time of diagnosis.
- Obstacles to the incorporation of palliative care from the time of diagnosis include the possibility that the current model provides sufficient care in these areas and the possibility that families may be averse to early palliative care involvement on the grounds that it would be intrusive, detract from their goal of cure, and/or lead to a loss of hope.
- To gather data relevant to evaluating these potential obstacles, we plan to interview pediatric oncology patients and their parents to determine their views regarding provision of palliative care, along with cancer therapy, from the time of diagnosis.
Objectives:
- Primary
- To assess parent and patient attitudes toward the integration of palliative care in pediatric oncology patients from the time of diagnosis.
- To develop a survey instrument that can reliably assess the views of pediatric oncology patients and their parents with regard to patients symptom burden and management at the beginning of cancer therapy as well as attitudes toward early integration of palliative care with oncology care.
- Secondary/Specific Objectives
- To assess the degree and effect of negative symptoms in children with cancer in the beginning of cancer therapy as well as the extent to which pediatric patients symptoms and suffering at this time are being adequately managed.
- To assess the emphasis that families place on quality of life in symptom management and treatment decision making as well as the satisfaction with the degree of attention given to quality of life by the medical team.
- To assess patient and parent attitudes toward palliative care in general and receptivity toward pediatric palliative care team involvement from the time of diagnosis.
- To assess understanding of prognosis and its relationship to parent and patient attitudes toward the integration of palliative care in pediatric oncology care from the time of diagnosis.
- To assess concordance between parents and patients in their attitudes toward the integration of palliative care in pediatric oncology patients from the time of diagnosis.
Eligibility:
-Patients eligible for inclusion will be children diagnosed with an oncologic disease at least 1 month and no greater than 1 year prior with age at diagnosis of 10 to 17 years. Both patient and parent must agree to participate to be eligible for inclusion.
Design:
- Surveys will be administered to consenting patient/parent pairs with the parent completing a written survey while the patient is surveyed in the absence of the participating parent.
- Total enrollment will be a minimum of 70 subject pairs and a maximum of 110 subject pairs with a target goal of 100 subject pairs enrolled over a 6 month period.
Data collected from responses to the surveys will be analyzed at the conclusion of the survey period to assess for individual content as well as concordance between the patients and their parents.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Current patients receiving clinical care for cancer at one of the participating sites.
- At least 1 month and no more than 1 year after initial diagnosis.
- Physically and cognitively able to participate in a 30 minute interview as determined by the primary medical providers.
- Ability to understand and speak English.
- Age 10-17 at the time of first diagnosis.
Key exclusion criteria (4 listed)
- Inability to speak English.
- Inability to understand spoken English.
- Parent s inability to read written English.
- Lack of agreement of both parent and child to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Oct 2017.
- Background: PubMed 15263058Harris MB. Palliative care in children with cancer: which child and when? J Natl Cancer Inst Monogr. 2004;(32):144-9. doi: 10.1093/jncimonographs/lgh007.
- Background: PubMed 12365026Gatta G, Capocaccia R, Coleman MP, Ries LA, Berrino F. Childhood cancer survival in Europe and the United States. Cancer. 2002 Oct 15;95(8):1767-72. doi: 10.1002/cncr.10833.
- Background: PubMed 10655532Wolfe J, Grier HE, Klar N, Levin SB, Ellenbogen JM, Salem-Schatz S, Emanuel EJ, Weeks JC. Symptoms and suffering at the end of life in children with cancer. N Engl J Med. 2000 Feb 3;342(5):326-33. doi: 10.1056/NEJM200002033420506.
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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.
David Wendler, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 Cancer, run by National Institutes of Health Clinical Center (CC) 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 12 inclusion and 4 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 6 Oct 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01273194, which also lists 3 linked publications.
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 6 Oct 2017.