OsteosarcomaNCT00923650
Informed Consent in Pediatric Cancer Trials
An observational study of Osteosarcoma and Ewing's Sarcoma, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Background: Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study. It consists of meetings and discussions with the health care team. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Osteosarcoma, Ewing's Sarcoma, Neuroblastoma
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2008to 2 Feb 2010
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parent/Guardian:
- Patient must be less than or equal to 21 years of age at the time of consent.
- Parent/guardian must be considering having their child participate in a Phase I treatment trial
- Parents must be able to speak English or Spanish
- Must sign informed consent for participation in this study
- Patients greater than or equal to14 years of age and less than or equal to 18 years of age:
Show all 18Show fewer
- Must be considering participating in a Phase I treatment trial
- Must be able to speak English or Spanish
- Must assent for participation in this study
- Patients greater than or equal to 18 years old:
- Must be considering participating in a Phase I treatment trial
- Must be able to speak English or Spanish
- Must sign informed consent for participation in this study, which will include consent to interview parent/guardian, if available
- Heath Care Team Members:
- Must be greater than or equal to 18 years of age
- Must speak English or Spanish
- Must sign an informed consent document for participation in this study (written consent will be obtained annually for heath care team members)
- Verbal assent to participate in each individual consent conference
Who cannot join
- Patients who are newly diagnosed who are being offered participation in a Phase I trial because no standard therapy exists for their disease
- Patients/Parents who have previously participated in informed consent research conducted by Cleveland Clinic Foundation Department of Bioethics
- Families who do not speak English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Cleveland Clinic Foundation Childrens Hospital
Cleveland, Ohio, 44195
About this study
Official title: Informed Consent in Pediatric Phase I Cancer Trials
Background:
- Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study. It consists of meetings and discussions with the health care team.
- Phase I clinical trials are designed to determine what dose of an investigational agent is safe to administer to patients.
Read more
Objectives:
- To study communication, comprehension and decision-making during the informed consent process.
- To examine ethical, psychological, social, and educational issues regarding informed consent.
- To help researchers understand how to improve informed consent and education about clinical research.
Eligibility:
- Parents or guardians of children with cancer who are being considered for participation in phase I clinical trials
- Prospective patients for pediatric phase I clinical trials who are between 14 and 21 years of age.
- Members of the research team who obtain consent from patients and families for pediatric phase I clinical trials
Design:
- Research assistants observe and record the informed consent conference held with the research team and the parents and children.
- After the conference, the research assistant interviews the parents in a private area about their experience during the conference and their decision-making process. They are asked about their thoughts and opinions during the informed consent conference, including the decision-making process, communication and trust in the medical team.
- With their parent's permission, patients are interviewed privately to discuss their experience during the informed consent conference.
- After parents and patients have made their decision about participation in the study, they are interviewed again about how they made the decision, aspects of the communication during the conference, and how they feel about the doctor. This interview is also recorded.
- Parents may be contacted 6 months to 2 years from the time of their participation to be part of a parent advisory group about the informed consent process.
Read the detailed description
Background:
- The clinical course and poor prognosis of children and adolescents eligible for pediatric phase I trials may increase the vulnerability of patients and their families and confound informed consent
- Physicians report a tension between presenting reasonable options and a truthful prognosis while maintaining hope.
- Research on the communication and decisions regarding participation in pediatric phase I trial is needed.
Objectives:
- The primary objective of this study is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials (Specific Aim 1) by examining:
- The way that phase I pediatric trials are presented (Aim 1 Hypothesis 1)
- Whether and how alternatives (such as hospice) are introduced (Aim 1 Hypothesis 2)
- What parents and children older than 14 years understand after the consent discussion (Aim 1 Hypothesis 3)
- How the communication process influences parental comprehension and decision-making regarding participation of their child in a phase I study (Aim 1 Hypothesis 4)
- How clinician-investigator perspectives may vary from that of the parent of a child participating in a phase I study (Aim 1 Hypothesis 5)
- Compare Phase I vs. Phase III pediatric cancer informed consent (Specific Aim 2) regarding:
- Parental understanding of the scientific goals of the trial (Aim 2 Hypothesis 1)
- Trust, decision making preferences, strength of recommendation by investigators interactivity as measured by number of parental questions, reasons for decisions, child's involvement, reading consent document, parental understanding of choice and trial design/purpose, disclosure of prognosis (Aim 2 Hypothesis 1-9)
- Develop suggestions for interventions to improve informed consent in Phase I pediatric cancer trials through Parent Advisory Group on Informed Consent (PAGIC).(Specific Aim 3)
Eligibility:
- Parents or guardians of children and adolescents considering enrollment on Phase I Trials of anti-cancer agents, gene transfer or vaccine studies are eligible if the child or adolescent is less than 22yrs with diagnosed with a recurrent or refractory malignant solid tumor or leukemia.
- Participants must speak English or Spanish.
- Parents or guardians of children or adolescents who are newly diagnosed with cancer or previously participated in informed consent research are excluded.
- In addition, we plan to interview a smaller number of patients who are 14-21 years of age and who have participated in an informed consent conference for a Phase I cancer trial.
Design:
- Parents (n=132) of children or adolescents (age less than or equal to 21 years) who are being offered participation in a Phase I clinical trial for cancer will be sequentially recruited.
- The methods will include direct observation, digital recording of ICC, and questionnaires of parent/guardian, patients, and health care team members. Research Assistants (RAs) will be trained to observe and record all interactions between families and clinicians that relate to the Phase I clinical trial. Children over 14 years old will be interviewed using a separate instrument
- Data will be analyzed by quantitative and qualitative analytic methods. To assure 120 cases for analysis, the total accrual is 132 cases at six institutions, up to 100 will be accrued at the NCI.
- Conditions
- Osteosarcoma, Ewing's Sarcoma, Neuroblastoma, Brain Tumors, Leukemia
- Keywords
- Informed Consent, Pediatric Phase I Clinical Trials, Assent, Questionnaires, Osteosarcoma, Ewing's Sarcoma, Neuroblastoma, Brain Tumors, Leukemia
- Medical subject headings
- Osteosarcoma, Sarcoma, Ewing, Neuroblastoma, Brain Neoplasms, Leukemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start9 Dec 2008
- Study completion2 Feb 2010
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 OsteosarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923650
- Sponsor's protocol ID
- 090052
- Other IDs
- 09-C-0052
- Status last verified
- 2 Feb 2010
- First submitted
- 17 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Sunkel C, Cillero F, Armijo M. [2-(p-Acetamidophenyloxy)ethyl-o-acetoxybenzoate (eterilate). A new anti-inflammatory derived from acetylsalicylic acid. Synthesis and its physico-chemical properties]. Arch Farmacol Toxicol. 1978 Apr;4(1):153-5. No abstract available. Spanish.
PubMed 697385Lind SE. Can patients be asked to pay for experimental treatment? Clin Res. 1984 Oct;32(4):393-8. No abstract available.
PubMed 6509865Ting AT, Karnitz LM, Schoon RA, Abraham RT, Leibson PJ. Fc gamma receptor activation induces the tyrosine phosphorylation of both phospholipase C (PLC)-gamma 1 and PLC-gamma 2 in natural killer cells. J Exp Med. 1992 Dec 1;176(6):1751-5. doi: 10.1084/jem.176.6.1751.
PubMed 1281218
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Consent in Pediatric Phase I Cancer Trials
- ClinicalTrials.gov ID
- NCT00923650
- Acronym / sponsor ID
- 090052
- Conditions
- Osteosarcoma, Ewing's Sarcoma, Neuroblastoma, Brain Tumors, Leukemia
- Keywords
- Informed Consent, Pediatric Phase I Clinical Trials, Assent, Questionnaires, Osteosarcoma, Ewing's Sarcoma, Neuroblastoma, Brain Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Dec 2008
- Study completion
- 2 Feb 2010
- First posted
- 18 Jun 2009 (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:
- Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study. It consists of meetings and discussions with the health care team.
- Phase I clinical trials are designed to determine what dose of an investigational agent is safe to administer to patients.
Objectives:
- To study communication, comprehension and decision-making during the informed consent process.
- To examine ethical, psychological, social, and educational issues regarding informed consent.
- To help researchers understand how to improve informed consent and education about clinical research.
Eligibility:
- Parents or guardians of children with cancer who are being considered for participation in phase I clinical trials
- Prospective patients for pediatric phase I clinical trials who are between 14 and 21 years of age.
- Members of the research team who obtain consent from patients and families for pediatric phase I clinical trials
Design:
- Research assistants observe and record the informed consent conference held with the research team and the parents and children.
- After the conference, the research assistant interviews the parents in a private area about their experience during the conference and their decision-making process. They are asked about their thoughts and opinions during the informed consent conference, including the decision-making process, communication and trust in the medical team.
- With their parent's permission, patients are interviewed privately to discuss their experience during the informed consent conference.
- After parents and patients have made their decision about participation in the study, they are interviewed again about how they made the decision, aspects of the communication during the conference, and how they feel about the doctor. This interview is also recorded.
- Parents may be contacted 6 months to 2 years from the time of their participation to be part of a parent advisory group about the informed consent process.
Detailed description
Background:
- The clinical course and poor prognosis of children and adolescents eligible for pediatric phase I trials may increase the vulnerability of patients and their families and confound informed consent
- Physicians report a tension between presenting reasonable options and a truthful prognosis while maintaining hope.
- Research on the communication and decisions regarding participation in pediatric phase I trial is needed.
Objectives:
- The primary objective of this study is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials (Specific Aim 1) by examining:
- The way that phase I pediatric trials are presented (Aim 1 Hypothesis 1)
- Whether and how alternatives (such as hospice) are introduced (Aim 1 Hypothesis 2)
- What parents and children older than 14 years understand after the consent discussion (Aim 1 Hypothesis 3)
- How the communication process influences parental comprehension and decision-making regarding participation of their child in a phase I study (Aim 1 Hypothesis 4)
- How clinician-investigator perspectives may vary from that of the parent of a child participating in a phase I study (Aim 1 Hypothesis 5)
- Compare Phase I vs. Phase III pediatric cancer informed consent (Specific Aim 2) regarding:
- Parental understanding of the scientific goals of the trial (Aim 2 Hypothesis 1)
- Trust, decision making preferences, strength of recommendation by investigators interactivity as measured by number of parental questions, reasons for decisions, child's involvement, reading consent document, parental understanding of choice and trial design/purpose, disclosure of prognosis (Aim 2 Hypothesis 1-9)
- Develop suggestions for interventions to improve informed consent in Phase I pediatric cancer trials through Parent Advisory Group on Informed Consent (PAGIC).(Specific Aim 3)
Eligibility:
- Parents or guardians of children and adolescents considering enrollment on Phase I Trials of anti-cancer agents, gene transfer or vaccine studies are eligible if the child or adolescent is less than 22yrs with diagnosed with a recurrent or refractory malignant solid tumor or leukemia.
- Participants must speak English or Spanish.
- Parents or guardians of children or adolescents who are newly diagnosed with cancer or previously participated in informed consent research are excluded.
- In addition, we plan to interview a smaller number of patients who are 14-21 years of age and who have participated in an informed consent conference for a Phase I cancer trial.
Design:
- Parents (n=132) of children or adolescents (age less than or equal to 21 years) who are being offered participation in a Phase I clinical trial for cancer will be sequentially recruited.
- The methods will include direct observation, digital recording of ICC, and questionnaires of parent/guardian, patients, and health care team members. Research Assistants (RAs) will be trained to observe and record all interactions between families and clinicians that relate to the Phase I clinical trial. Children over 14 years old will be interviewed using a separate instrument
- Data will be analyzed by quantitative and qualitative analytic methods. To assure 120 cases for analysis, the total accrual is 132 cases at six institutions, up to 100 will be accrued at the NCI.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Parent/Guardian:
- Patients greater than or equal to14 years of age and less than or equal to 18 years of age:
- Patients greater than or equal to 18 years old:
- Heath Care Team Members:
Key exclusion criteria (3 listed)
- Patients who are newly diagnosed who are being offered participation in a Phase I trial because no standard therapy exists for their disease
- Patients/Parents who have previously participated in informed consent research conducted by Cleveland Clinic Foundation Department of Bioethics
- Families who do not speak English or Spanish
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 2 Jul 2017.
- Background: PubMed 697385Sunkel C, Cillero F, Armijo M. [2-(p-Acetamidophenyloxy)ethyl-o-acetoxybenzoate (eterilate). A new anti-inflammatory derived from acetylsalicylic acid. Synthesis and its physico-chemical properties]. Arch Farmacol Toxicol. 1978 Apr;4(1):153-5. No abstract available. Spanish.
- Background: PubMed 6509865Lind SE. Can patients be asked to pay for experimental treatment? Clin Res. 1984 Oct;32(4):393-8. No abstract available.
- Background: PubMed 1281218Ting AT, Karnitz LM, Schoon RA, Abraham RT, Leibson PJ. Fc gamma receptor activation induces the tyrosine phosphorylation of both phospholipase C (PLC)-gamma 1 and PLC-gamma 2 in natural killer cells. J Exp Med. 1992 Dec 1;176(6):1751-5. doi: 10.1084/jem.176.6.1751.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma and Ewing's Sarcoma, run by National Cancer Institute (NCI) at 2 sites 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 18 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 NCT00923650, 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 2 Jul 2017.