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Parental Decision-Making for Children With Relapsed Neuroblastoma

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ClinicalTrials.gov Identifier: NCT02282735
Recruitment Status : Active, not recruiting
First Posted : November 4, 2014
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jennifer Mack, MD, Dana-Farber Cancer Institute

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.


Condition or disease
Relapsed Neuroblastoma

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.


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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parental Decision-Making for Children With Relapsed Neuroblastoma
Study Start Date : May 2013
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma




Primary Outcome Measures :
  1. Number of parents who prefer life-prolonging care [ Time Frame: 18 months ]
    Questionnaire-based measure


Secondary Outcome Measures :
  1. Number of parents who experience decisional regret [ Time Frame: 18 months ]
    Questionnaire-based measure

  2. Number of parents who report that care has been burdensome [ Time Frame: 18 months ]
    Questionnaire-based measure

  3. Number of parents who report that care received is consonant with the parent's preferences [ Time Frame: 18 months ]
    Questionnaire-based measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parents of children with relapsed or refractory neuroblastoma.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282735


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Stanford/Packard's Children's Hospital
Palo Alto, California, United States, 94304
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Cook's Children's Healthcare System
Fort Worth, Texas, United States, 76104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98145
Sponsors and Collaborators
Dana-Farber Cancer Institute
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jennifer W Mack, MD MPH Dana-Farber Cancer Institute

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Responsible Party: Jennifer Mack, MD, Attending Physician, Pediatric Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02282735     History of Changes
Other Study ID Numbers: 13-083
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Keywords provided by Jennifer Mack, MD, Dana-Farber Cancer Institute:
neuroblastoma
end-of-life
decision-making
parent
child
prognosis
preferences
childhood cancer
oncology
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue