- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02608307
Medical Treatment Decision Making Using Adaptive Conjoint Analysis
Adolescent and Young Adult, Parental, and Health Care Provider Decision Making Using Conjoint Analysis
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.
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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AYA patients
Adolescence and young adults (AYA) who meet eligibility criteria and consent to participate in the study.
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Parents of AYA patients
Parents of AYA patients who meet eligibility criteria and consent to participate in the study.
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Health Care Providers (HCPs)
Health care providers who meet eligibility criteria and consent to participate in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Part Worths
Time Frame: Once at participant enrollment
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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.
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Once at participant enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: Lindsay Blazin, MD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYACA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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