Medical Treatment Decision Making Using Adaptive Conjoint Analysis

NCT02608307 | Terminated

• 1 other identifier: AYACA
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In the setting of progressive or recurrent cancer, adolescent and young adult (AYA) patients, parents, and healthcare providers (HCP) are faced with multiple therapeutic options. Each treatment option has a unique risk/benefit ratio, resulting in a need to trade one desirable outcome for another or accept acute toxicities and treatment-related morbidity to increase the chance of survival. Adding to the complexity of this decision, stake holders characterize and value the risk/benefit ratios differently. This study seeks to learn what things are important to an adolescent or young adult with cancer, parents, and health care providers when making decisions about their treatment choices. PRIMARY OBJECTIVE: To quantify the relative importance of various factors believed to be important to adolescent and young adult patients with cancer, parents, and health care providers when choosing between treatment options in the hypothetical situation of progressive or refractory disease.

Conditions

Cancer; Brain Tumor; Solid Tumor; Leukemia; Lymphoma

Keywords

Treatment Decision-Making; Adolescents and Young Adult Oncology

Outcome Measures

Primary Outcomes (1)

• Part Worths

  Conjoint analysis picks a small subset of possible answer combinations and combination sets and asks respondents which option (profile) they prefer in each set. This data is compiled and a hierarchical Bayesian approach, as implanted in Sawtooth Software package, is used to evaluate the relationship between various attributes and the decision choice. The relative importance of various factors on the decision-making process will be evaluated for three groups (patients, parents and HCPs) independently, generating three separate models. At completion of the survey, the part worth for each different treatment attribute (type, location, hospital, route, symptoms or side effects, frequency of clinic visits, chance of hospitalization, quality of life, chance of cure, and survival length of time) is calculated. They are analyzed simultaneously for each participant and only have meaning in relation to one another constituting a single primary outcome measure.

  Once at participant enrollment

Study Arms (3)

AYA patients

Adolescence and young adults (AYA) who meet eligibility criteria and consent to participate in the study.

Parents of AYA patients

Parents of AYA patients who meet eligibility criteria and consent to participate in the study.

Health Care Providers (HCPs)

Health care providers who meet eligibility criteria and consent to participate in the study.

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients at St. Jude Children's Research Hospital, their parents and health-care providers who consent to enroll in the study. All participants must meet inclusion criteria.

You may qualify if:

• Participants must be English speaking.
• There are three main participant subsets for the first time point of the study:
• AYA patients (aged 13-30) with an oncological diagnosis who are currently receiving active treatment at St. Jude Children's Research Hospital that includes at least chemotherapy, and have been doing so for at least one month or who completed treatment (that includes at least chemotherapy) less than 1 month prior to enrollment.
• Parents of a patient (\<18) who meets the above criteria. If available, parents of a young adult patient (≥18) who meets the above criteria will be invited to participate.
• HCPs of patients at St. Jude with at least 1 year of experience taking care of AYA oncology patients. HCPs must have an MD or DO degree and be an attending physician or clinical fellow at St. Jude Children's Research Hospital.
• Patient participants must have an oncological diagnosis that confers less than a 75% overall survival based on consultation with an oncologist.
• Participants who agree to be re-contacted up to five years later, to consider taking part in the T2 time point, must have participated in the T1 time point and the patient participant must have relapsed or recurrent disease at the time of re- contact, as documented in the medical record.

You may not qualify if:

• Patients with relapsed or recurrent disease at the time of initial enrollment.
• Patients who only receive local radiation for treatment without adjunctive chemotherapy.
• Patients or parents who are unable to complete the study due to ill health, cognitive compromise, or concern about potential distress based on consultation with a psychosocial provider.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Lindsay Blazin, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 18, 2015
• Study Start: February 9, 2016
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: December 21, 2021

Record last verified: 2021-10

Locations

US (1)