Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study (NCT05352451) | Clinical Trial Compass
CompletedNot Applicable
Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
United States29 participantsStarted 2022-05-09
Plain-language summary
Primary Objective:
Aim 1: To evaluate the acceptability and feasibility of recruitment strategies for subjects for VOICE 2 intervention.
Secondary Objective:
Aim 2: To test the preliminary efficacy of VOICE 2 on oncologist-patient, patient-caregiver, and oncologist-caregiver concordant prognostic understanding, oncologist-patient and oncologist-caregiver therapeutic alliance, patient/caregiver depression/anxiety and death anxiety, and patient/caregiver meaning/purpose.
Who can participate
Age range
21 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.
Inclusion Criteria:
* Participant of an oncologist participating in this study
* Received a diagnosis of hematologic cancer with disease progression following second-line treatment, OR a diagnosis of stage IV gastrointestinal, genitourinary, gynecologic, skin/soft tissue or thoracic/head and neck cancer
* Fluent in English or Spanish and prefer speaking English or Spanish when talking about health care
* 21 years or older;
* Have a primary informal caregiver (as defined by an unpaid individual who provides you with emotional, physical, and/or practical support) who is willing and able to participate in the study
* Able to communicate over the phone with the study team staff
* Willing to be audio-recorded for study-related communication
Exclusion Criteria:
* Test result on mental status do not meet the requirement for this study
* Receiving hospice care now
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.
What they're measuring
1
Open-ended, Likert scale will measure fidelity
Timeframe: Two years
2
Multiple-choice questions will measure fidelity
Timeframe: Two years
Trial details
NCT IDNCT05352451
SponsorRutgers, The State University of New Jersey