Health OptionsNCT06722846
Communicating Health Options to Inform Care and Empower Strategic Care Planning (CHOICES): A Multi-layer Randomized Case Vignette Study.
An observational study of Health Options and Strategic Care Planning, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn more about how the delivery of medical information affects therapy choices for participants with advanced forms of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Options, Strategic Care Planning
- What is being tested?
- Randomized Case Vignette Study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 31 Aug 2028
- Phase
- Observational
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 18 years and older
- All sexes
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- Diagnosis of advanced solid tumor (i.e. metastatic, relapsed, and/or incurable disease) or aggressive lymphoma.
- Age 18 or greater
- Seen at MD Anderson Cancer Center Thoracic and Lymphoma Oncology Clinics for a follow-up visit
- Been treated with at least 2 lines of palliative systemic cancer therapies
Who cannot join
- Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
David Hui, MD, 713-792-6258, dhui@mdanderson.org
About this study
To learn more about how the delivery of medical information affects therapy choices for participants with advanced forms of cancer.
Read the detailed description
Primary Objectives • To examine how provision of medical information (risks, benefits, time toxicity, prognosis, oncologists' recommendation, and costs) affects preference for palliative systemic therapy in participants with advanced cancer.
Secondary Objective
- To examine how different options of medical information (risks/benefits, time toxicity, prognosis, oncologists' recommendation, and costs) affect preference for palliative systemic therapy in participants with advanced cancer.
Exploratory Objective
- To examine how the order of presentation of medical information affects preference for palliative systemic therapy in participants with advanced cancer.
- To examine the association between intrinsic participants characteristics (such as participants demographics, symptoms, anxiety, depression, illness understanding, acceptance, coping strategies, religious coping, hope, decision making style, trust in oncologist, financial distress) and preference for palliative systemic therapy in participants with advanced cancer.
- Conditions
- Health Options, Strategic Care Planning
- Being tested
- Randomized Case Vignette Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized Case Vignette StudyBehavioural
Particpants will complete about 16 questionnaires that will have questions about particpants quality of life, anxiety, health, andcase scenarios that are not real or based on particpants actual health situation.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Case Vignette Study | If participants agree to take part in this study, participants will complete about 16 questionnaires that will have questions about participants quality of life, anxiety, health, and case scenarios that are not real or based on your actual health situation. It should take a bit more than an hour to complete all the questionnaires. If participants find that any of these questions are difficult to read, understand, or otherwise complete; or if they cause distress, participants may ask the study team for clarification, skip the question, or even stop the study at any time.
Additionally, information will be collected from participants medical record about participants health and treatment, as well as participants demographic information (age, race, sex, and so on). Investigators may also ask participants for additional demographic information not found in your medical record. Receives: Behavioral: Randomized Case Vignette Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Progression Free Survival (PFS)
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start21 Nov 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health OptionsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722846
- Sponsor's protocol ID
- 2024-0531
- Other IDs
- NCI-2024-10042
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No