Medical Treatment Decision Making Using Adaptive Conjoint Analysis
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|ClinicalTrials.gov Identifier: NCT02608307|
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : January 6, 2020
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.
|Condition or disease|
|Cancer Brain Tumor Solid Tumor Leukemia Lymphoma|
Data for this observational study will be collected first at the time the participants enroll in the study. If the participant agrees to be re-contacted in the event of disease relapse or recurrent cancer, follow-up data will be collected at a second time point up to five years after enrollment. This second follow-up time point is optional.
Participants will complete two short questionnaires and a guided survey on a laptop computer. AYA patients and parents will participate in an interviewer-led interview session. The surveys are the Herth Hope Index (HHI) to assess hope in adults in clinical settings, and the Decision Making Preference Questionnaire (DMPQ) to identify factors that parents believe influence their role in treatment decision making. The guided survey presents a hypothetical situation outlining different treatment options at the time of recurrent or progressive disease. Participants will be asked to answer questions related to type of treatment, location of treatment, hospital of treatment, route of treatment, symptoms or side effects from treatment, quality of life, frequency of clinic visits, chance of being hospitalized, chance of cure, and survival length of time.
Medical data including cancer diagnosis, date of diagnosis, duration of time on treatment, and serious side effects and complications of treatment will be collected on AYA patients.
Data will be analyzed by group: (1) adolescent and young adult patients, (2) parents, or (3) health-care providers.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Adolescent and Young Adult, Parental, and Health Care Provider Decision Making Using Conjoint Analysis|
|Actual Study Start Date :||February 9, 2016|
|Estimated Primary Completion Date :||January 2026|
|Estimated Study Completion Date :||January 2026|
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.
- Part Worths [ Time Frame: Once at participant enrollment ]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.
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): NCT02608307
|Contact: Lindsay Blazin, MDemail@example.com|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: lindsay Blazin, MD 866-278-5833 firstname.lastname@example.org|
|Principal Investigator: Lindsay Blazin, MD|
|Principal Investigator:||Lindsay Blazin, MD||St. Jude Children's Research Hospital|