Advance care planning discussions for young adults undergoing stem cell transplants
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
This study is trying to see if having ongoing conversations about care preferences helps young adults aged 18 to 39 who are getting stem cell transplants and their caregivers feel more comfortable and supported during the process.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05605574 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to assess the feasibility and acceptability of conducting longitudinal advance care planning (ACP) discussions with adolescents and young adults (AYAs) aged 18 to 39 years who are scheduled to undergo hematopoietic stem cell transplantation (HSCT). Participants, along with their identified caregivers, will engage in a series of structured conversations to express their values and goals regarding care during the transplant process. The study will involve completing a 20-minute questionnaire to gather insights on the impact of these discussions on patient-centered care. The goal is to overcome barriers to ACP conversations and improve communication between patients, caregivers, and healthcare providers.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adolescents and young adults aged 18 to 39 who are scheduled for an allogeneic HSCT.
Not a fit: Patients who are not English-speaking or those outside the age range of 18 to 39 years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of care and decision-making for young adults undergoing HSCT by ensuring their values and preferences are prioritized.
How similar studies have performed: While there have been studies on advance care planning in other populations, this specific approach with AYAs undergoing HSCT is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * AYA Participants: * Age \>= 18 to \<= 39 years. * Planned allogeneic HSCT at a participating site. * Participants must be English speaking. * Ability to understand and the willingness to sign a written informed consent document. * Caregiver Participants: * Age: \>= 18 years. * Identified as caregiver by participating AYA participant. Only a single caregiver will be allowed to participate. * Physically present at the participating site. * Participants must be English speaking. * Ability to understand and the willingness to sign a written informed consent document. * Provider participants: Healthcare providers at the participating site who are part of the AYA participant s HSCT team and provided direct clinical care to AYA participants during period of study enrollment between completion of conversation #1 and conversation #3. EXCLUSION CRITERIA: None.
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Lori S Wiener, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: Brian W Pennarola, M.D.
- Email: brian.pennarola@nih.gov
- Phone: (240) 760-7250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.