Clinical trial NCT02608307: Medical Treatment Decision Making Using Adaptive Conjoint Analysis
Official title: Adolescent and Young Adult, Parental, and Health Care Provider Decision Making Using Conjoint Analysis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Brain Tumor
Solid Tumor
Leukemia
Lymphoma
Keywords: Treatment Decision-Making
Adolescents and Young Adult Oncology
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part Worths
timeFrame: Once at participant enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Lindsay Blazin, MD
role: PRINCIPAL_INVESTIGATOR
References: