NCT02282735

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2013Jun 2027

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

5.9 years

First QC Date

October 30, 2014

Last Update Submit

July 25, 2025

Conditions

Keywords

neuroblastomaend-of-lifedecision-makingparentchildprognosispreferenceschildhood canceroncology

Outcome Measures

Primary Outcomes (1)

  • Number of parents who prefer life-prolonging care

    Questionnaire-based measure

    18 months

Secondary Outcomes (3)

  • Number of parents who experience decisional regret

    18 months

  • Number of parents who report that care has been burdensome

    18 months

  • Number of parents who report that care received is consonant with the parent's preferences

    18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parents of children with relapsed or refractory neuroblastoma.

You may qualify if:

  • 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.

You may not qualify if:

  • Delirium/dementia as judged by the treating physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Stanford/Packard's Children's Hospital

Palo Alto, California, 94304, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Cook's Children's Healthcare System

Fort Worth, Texas, 76104, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98145, United States

Location

MeSH Terms

Conditions

NeuroblastomaDeathNeoplasms

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer W Mack, MD MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Pediatric Oncology

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 4, 2014

Study Start

May 1, 2013

Primary Completion

April 1, 2019

Study Completion (Estimated)

June 1, 2027

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations