CancerNCT02608307
Medical Treatment Decision Making Using Adaptive Conjoint Analysis
An observational study of Cancer and Brain Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Brain Tumor, Solid Tumor
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2016to 17 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Brain Tumor, Solid Tumor, Leukemia, Lymphoma
- Keywords
- Treatment Decision-Making, Adolescents and Young Adult Oncology
- Medical subject headings
- Neoplasms, Brain Neoplasms, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once at participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start9 Feb 2016
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Why it stopped: Slow accrual and COVID-19 restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay Blazin, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608307
- Sponsor's protocol ID
- AYACA
- Status last verified
- Oct 2021
- First submitted
- 13 Nov 2015
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent and Young Adult, Parental, and Health Care Provider Decision Making Using Conjoint Analysis
- ClinicalTrials.gov ID
- NCT02608307
- Acronym / sponsor ID
- AYACA
- Conditions
- Cancer, Brain Tumor, Solid Tumor, Leukemia, Lymphoma
- Keywords
- Treatment Decision-Making, Adolescents and Young Adult Oncology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual and COVID-19 restrictions
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 9 Feb 2016 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Participants must be English speaking.
- There are three main participant subsets for the first time point of the study:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Slow accrual and COVID-19 restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Blazin, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Brain Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual and COVID-19 restrictions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part Worths (time frame: Once at participant enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.