Relapsed NeuroblastomaNCT02282735
Parental Decision-Making for Children With Relapsed Neuroblastoma
An observational study of Relapsed Neuroblastoma, run by Dana-Farber Cancer Institute at 9 sites in United States.
Trial summary
Parental decision-making for children with advanced cancer is complex. Many parents have overly optimistic beliefs about prognosis and as a result choose aggressive measures even at the end of life, which are associated with greater suffering. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Neuroblastoma
- How many people
- 96 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2013to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of children with relapsed or refractory neuroblastoma.
Who may be able to join
- Parent of a child with relapsed or refractory high risk neuroblastoma, as defined by the International Neuroblastoma Risk Group, without respect to timing of first determination of relapse or refractory disease;
- Parent aged 18 years or older, of a child aged <=18 years;
- English- or Spanish-speaking.
Who cannot join
- Delirium/dementia as judged by the treating physician
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Chicago Medical Center
Chicago, Illinois, 60637
Cook's Children's Healthcare System
Fort Worth, Texas, 76104
Children's Hospital of Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Columbia University Medical Center
New York, New York, 10032
Stanford/Packard's Children's Hospital
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98145
About this study
Parental decision-making for children with advanced cancer is complex. Many parents have overly optimistic beliefs about prognosis and as a result choose aggressive measures even at the end of life, which are associated with greater suffering. Yet most parents wish to limit suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer. These findings suggest that parents do not always have the information they need to make decisions that reflect their preferences.
The proposed study will evaluate parental decision-making in advanced cancer, addressing gaps in the literature in 3 important respects. 1) Previous work on decision-making for children with advanced cancer has typically looked at decisions at one point in time, often asking parents to reflect on decisions after the child's death, even though parents' understanding of prognosis and decisions about care evolve over time. We will evaluate parental decision-making for advanced cancer over time. 2) Existing work focuses on aggressive end-of-life care as the worst possible outcome. However, some parents wish to pursue aggressive measures even when they recognize that the child has little chance for cure. We will evaluate the extent to which parental decision-making is informed and consonant with preferences, regardless of whether decisions lead to aggressive or palliative care. 3) Previous studies have focused on groups of different childhood cancers, making it difficult to ascertain whether differences in decision-making reflect differences in diseases, options for care, or parent preferences. We will focus on a single disease, relapsed neuroblastoma, as a model for parental decision-making.
Read the detailed description
Parental decision-making for children with advanced cancer is complex. Many parents have overly optimistic beliefs about prognosis and as a result choose aggressive measures even at the end of life, which are associated with greater suffering. Yet most parents wish to limit suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer. These findings suggest that parents do not always have the information they need to make decisions that reflect their preferences.
The proposed study will evaluate parental decision-making in advanced cancer, addressing gaps in the literature in 3 important respects. 1) Previous work on decision-making for children with advanced cancer has typically looked at decisions at one point in time, often asking parents to reflect on decisions after the child's death, even though parents' understanding of prognosis and decisions about care evolve over time. We will evaluate parental decision-making for advanced cancer over time. 2) Existing work focuses on aggressive end-of-life care as the worst possible outcome. However, some parents wish to pursue aggressive measures even when they recognize that the child has little chance for cure. We will evaluate the extent to which parental decision-making for advanced cancer is informed and consonant with preferences, regardless of whether decisions lead to aggressive or palliative care. 3) Previous studies have focused on groups of different childhood cancers, making it difficult to ascertain whether differences in decision-making reflect differences in diseases, options for care, or parent preferences. We will focus on a single disease, relapsed neuroblastoma, as a model for parental decision-making. Children with relapsed neuroblastoma have advanced cancer but many options for care, including established cancer regimens, clinical trials, and palliation. Relapsed neuroblastoma presents an ideal model for parental decision-making in the setting of a complex array of choices. We will follow 120 parents at 8 institutions over time, beginning at relapse and continuing over 18 months. Parent interviews every 3 months and reviews of medical records throughout that time will be used to evaluate the ways that parental preferences for the aggressiveness of treatment change over time (Aim 1). Parental perception that care has been burdensome will be evaluated as possible driver of change in decision-making (Aim 2). Ideally, parent values for care would be the primary driver of treatment goals. Thus we will evaluate the extent to which parental understanding of prognosis, treatment options, and expected benefits and burdens of treatment can allow decision-making consonant with parental preferences in the absence of prior negative experiences with care (Aim 3). Finally, in-depth parent interviews will allow us to evaluate personal factors that drive parental decision-making (Aim 4). Throughout the study, a Parent Advisory Group will guide assessment of care preferences and decision-making.
- Conditions
- Relapsed Neuroblastoma
- Keywords
- neuroblastoma, end-of-life, decision-making, parent, child, prognosis, preferences, childhood cancer, oncology
- Medical subject headings
- Neuroblastoma, Death, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parents who prefer life-prolonging care
Questionnaire-based measure
Measured: 18 months
Secondary outcomes (3)
Number of parents who experience decisional regret
Questionnaire-based measure
Measured: 18 months
Number of parents who report that care has been burdensome
Questionnaire-based measure
Measured: 18 months
Number of parents who report that care received is consonant with the parent's preferences
Questionnaire-based measure
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startMay 2013
- Primary completionApr 2019
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jennifer Mack, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer W Mack, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282735
- Sponsor's protocol ID
- 13-083
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2014
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Decision-Making for Children With Relapsed Neuroblastoma
- ClinicalTrials.gov ID
- NCT02282735
- Acronym / sponsor ID
- 13-083
- Conditions
- Relapsed Neuroblastoma
- Keywords
- neuroblastoma, end-of-life, decision-making, parent, child, prognosis, preferences, childhood cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- May 2013 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Nov 2014 (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.
Parental decision-making for children with advanced cancer is complex. Many parents have overly optimistic beliefs about prognosis and as a result choose aggressive measures even at the end of life, which are associated with greater suffering. Yet most parents wish to limit suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer. These findings suggest that parents do not always have the information they need to make decisions that reflect their preferences.
The proposed study will evaluate parental decision-making in advanced cancer, addressing gaps in the literature in 3 important respects. 1) Previous work on decision-making for children with advanced cancer has typically looked at decisions at one point in time, often asking parents to reflect on decisions after the child's death, even though parents' understanding of prognosis and decisions about care evolve over time. We will evaluate parental decision-making for advanced cancer over time. 2) Existing work focuses on aggressive end-of-life care as the worst possible outcome. However, some parents wish to pursue aggressive measures even when they recognize that the child has little chance for cure. We will evaluate the extent to which parental decision-making is informed and consonant with preferences, regardless of whether decisions lead to aggressive or palliative care. 3) Previous studies have focused on groups of different childhood cancers, making it difficult to ascertain whether differences in decision-making reflect differences in diseases, options for care, or parent preferences. We will focus on a single disease, relapsed neuroblastoma, as a model for parental decision-making.
Detailed description
Parental decision-making for children with advanced cancer is complex. Many parents have overly optimistic beliefs about prognosis and as a result choose aggressive measures even at the end of life, which are associated with greater suffering. Yet most parents wish to limit suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer. These findings suggest that parents do not always have the information they need to make decisions that reflect their preferences.
The proposed study will evaluate parental decision-making in advanced cancer, addressing gaps in the literature in 3 important respects. 1) Previous work on decision-making for children with advanced cancer has typically looked at decisions at one point in time, often asking parents to reflect on decisions after the child's death, even though parents' understanding of prognosis and decisions about care evolve over time. We will evaluate parental decision-making for advanced cancer over time. 2) Existing work focuses on aggressive end-of-life care as the worst possible outcome. However, some parents wish to pursue aggressive measures even when they recognize that the child has little chance for cure. We will evaluate the extent to which parental decision-making for advanced cancer is informed and consonant with preferences, regardless of whether decisions lead to aggressive or palliative care. 3) Previous studies have focused on groups of different childhood cancers, making it difficult to ascertain whether differences in decision-making reflect differences in diseases, options for care, or parent preferences. We will focus on a single disease, relapsed neuroblastoma, as a model for parental decision-making. Children with relapsed neuroblastoma have advanced cancer but many options for care, including established cancer regimens, clinical trials, and palliation. Relapsed neuroblastoma presents an ideal model for parental decision-making in the setting of a complex array of choices. We will follow 120 parents at 8 institutions over time, beginning at relapse and continuing over 18 months. Parent interviews every 3 months and reviews of medical records throughout that time will be used to evaluate the ways that parental preferences for the aggressiveness of treatment change over time (Aim 1). Parental perception that care has been burdensome will be evaluated as possible driver of change in decision-making (Aim 2). Ideally, parent values for care would be the primary driver of treatment goals. Thus we will evaluate the extent to which parental understanding of prognosis, treatment options, and expected benefits and burdens of treatment can allow decision-making consonant with parental preferences in the absence of prior negative experiences with care (Aim 3). Finally, in-depth parent interviews will allow us to evaluate personal factors that drive parental decision-making (Aim 4). Throughout the study, a Parent Advisory Group will guide assessment of care preferences and decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of children with relapsed or refractory neuroblastoma.
Key inclusion criteria (3 listed)
- Parent of a child with relapsed or refractory high risk neuroblastoma, as defined by the International Neuroblastoma Risk Group, without respect to timing of first determination of relapse or refractory disease;
- Parent aged 18 years or older, of a child aged <=18 years;
- English- or Spanish-speaking.
Key exclusion criteria (1 listed)
- Delirium/dementia as judged by the treating physician
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
Number of parents who prefer life-prolonging care
Time frame: 18 months
Questionnaire-based measure
3 secondary outcomes
Number of parents who experience decisional regret
Time frame: 18 months
Number of parents who report that care has been burdensome
Time frame: 18 months
Number of parents who report that care received is consonant with the parent's preferences
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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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.
Jennifer W Mack, MD MPH principal investigator
Dana-Farber Cancer Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Neuroblastoma, run by Dana-Farber Cancer Institute at 9 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of parents who prefer life-prolonging care (time frame: 18 months). 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 20 Aug 2026.