Clinical trial NCT02282735: Parental Decision-Making for Children With Relapsed Neuroblastoma
Official title: Parental Decision-Making for Children With Relapsed Neuroblastoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Relapsed Neuroblastoma
Keywords: neuroblastoma
end-of-life
decision-making
parent
child
prognosis
preferences
childhood cancer
oncology
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-04
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children with relapsed or refractory neuroblastoma.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Delirium/dementia as judged by the treating physician

Primary outcomes:
measure: Number of parents who prefer life-prolonging care
timeFrame: 18 months
Secondary outcomes:
measure: Number of parents who experience decisional regret
timeFrame: 18 months
measure: Number of parents who report that care has been burdensome
timeFrame: 18 months
measure: Number of parents who report that care received is consonant with the parent's preferences
timeFrame: 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford/Packard's Children's Hospital
state: California
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Fort Worth
country: United States
facility: Cook's Children's Healthcare System
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer W Mack, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: