Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer (NCT02108028) | Clinical Trial Compass
CompletedNot Applicable
Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer
United States272 participantsStarted 2014-04-03
Plain-language summary
Background:
\- There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful.
Objective:
\- To study if Voicing My CHOiCES(TM) can reduce anxiety, improve sense of support, and improve communication about advanced care planning.
Eligibility:
\- Adults 18 to 39 years old being treated for cancer.
Design:
* Participants will answer questions about their age, sex, employment, religion, health, and marital status. They will also complete several brief questionnaires:
1. General Anxiety Short Form
2. Peace, Equanimity and Acceptance in the Cancer Experience
3. Functional Assessment of Social Support
4. Quality of Communication
5. Prior Communication about Advanced Care Planning
* Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations.
* The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* ELIGIBILITY CRITERIA FOR PATIENT PARTICIPANTS (COHORT 1A, 1B, 2A, 2B, 3A \& 3B):
INCLUSION CRITERIA:
* Patients must be between ages: 18 through 39 years
* Patients must be diagnosed with cancer or other chronic illness.
* Patients must give informed consent.
* Patients must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS; Appendix
* Patients must be English or Spanish speaking.
* Cohorts 1B and 2B must be English speaking only.
EXCLUSION CRITERIA:
* Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator or consulting psychiatrist would compromise the patient s ability to engage in the intervention or is likely to interfere with the study procedures or results.
* Cognitive impairment which in the judgment of the Principal or Associate Investigatorwould compromise the patient s ability to understand the VMC material or is likely to interfere with the study procedures or results.
* Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the research team would compromise the patient s ability to tolerate or complete this study.
* Participants who have already completed the Voicing My CHOiCES tool.
ELIGIBILITY CRITERIA FOR NON-PATIENT PARTICPANTS (COHORT 4):
INCLUSION CRITERIA:
* Subject must be greater than or equal to 18 years of age
* Fam…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.