Parental Decision-Making for Children With Relapsed Neuroblastoma

• ClinicalTrials.gov Identifier: NCT02282735
• Recruitment Status: Active, not recruiting
• First Posted: November 4, 2014
• Last Update Posted: June 7, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Jennifer Mack, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: October 30, 2014
• First Posted Date: November 4, 2014
• Last Update Posted Date: June 7, 2023
• Actual Study Start Date: May 2013
• Actual Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 31, 2014)

Number of parents who prefer life-prolonging care [ Time Frame: 18 months ]

Questionnaire-based measure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 31, 2014)

• Number of parents who experience decisional regret [ Time Frame: 18 months ]
  Questionnaire-based measure
• Number of parents who report that care has been burdensome [ Time Frame: 18 months ]
  Questionnaire-based measure
• Number of parents who report that care received is consonant with the parent's preferences [ Time Frame: 18 months ]
  Questionnaire-based measure

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Parental Decision-Making for Children With Relapsed Neuroblastoma
• Official Title: Parental Decision-Making for Children With Relapsed 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Parents of children with relapsed or refractory neuroblastoma.
• Condition: Relapsed Neuroblastoma
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 20, 2018): 96
• Original Estimated Enrollment (submitted: October 31, 2014): 160
• Estimated Study Completion Date: June 2024
• Actual Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02282735
• Other Study ID Numbers: 13-083
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jennifer Mack, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Jennifer W Mack, MD MPH; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: June 2023