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Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
MinorEnrollment closed, study ongoingFinal enrollment: 35 participants (planned 222) · Study sites: 2 to 1Show 2 more changesShow less
Final enrollment: 35 participants (planned 222)
Study sites: 2 to 1
MinorEligibility criteria expanded, about 13 wordsSecondary endpoints: details revised at 2 of 3 entries · Site details revised at 1 of 2 sites · Study description expanded, about 3 wordsShow 3 more changesShow less
Secondary endpoints: details revised at 2 of 3 entries
Site details revised at 1 of 2 sites
Study description expanded, about 3 words
Minor2 versionsRe-verified since Jun 4, 2026, no change to tracked fieldsv47-v48
Minor2 versionsRe-verified since Jan 26, 2023, no change to tracked fieldsv13-v14
MinorStart date changed from estimate of Nov 23, 2022 to Nov 16, 2022v12
MinorStart date: Nov 22, 2022 to Nov 23, 2022v11
MinorStart date: Nov 21, 2022 to Nov 22, 2022v10
MinorStart date: Nov 20, 2022 to Nov 21, 2022v9
MinorStart date: Nov 17, 2022 to Nov 20, 2022v8
MinorStart date: Nov 16, 2022 to Nov 17, 2022v7
MinorStart date: Nov 15, 2022 to Nov 16, 2022v6
MinorStart date: Nov 14, 2022 to Nov 15, 2022v5
MinorStart date: Nov 13, 2022 to Nov 14, 2022v4
NotableTrial status: Not Yet Recruiting to RecruitingStart date: Nov 10, 2022 to Nov 13, 2022 · Site details revisedv3Show 2 more changesShow less
Start date: Nov 10, 2022 to Nov 13, 2022
Site details revised
MinorStart date: Nov 9, 2022 to Nov 10, 2022v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
For adolescent and young adults (AYAs) with certain life-threatening illnesses, hematopoietic stem cell transplant (HSCT) provides the best chance for cure and survival. HSCT is a life-saving therapy, but this treatment also comes with significant risks. Given these risks, it is imperative that patients and their families have the opportunity to share their values, priorities, and goals through advance care planning (ACP) to ensure that the care they receive through the transplant process remains patient-centered. Despite the benefits of ACP discussions, many barriers, including provider discomfort, may prevent these conversations with AYAs.
Objective:
To see if AYAs who undergo HSCT and their caregivers benefit from discussing ACP topics.
Eligibility:
People aged 18 to 39 years enrolled in an NIH study with a planned HSCT. One caregiver aged 18 years or older will also be invited to participate.
Design:
Participants will complete a 20-minute questionnaire. They will be asked about the priorities they have related to their care and their prior experiences with ACP.
Participants will have 3 conversations with a study team member over 4 to 9 weeks. Each talk will last 45 to 60 minutes.
First, participants will talk about their upcoming transplant and their expectations. They will also be asked about their fears and worries and will discuss what is most important to them in terms of support, comfort, their values, and their goals.
Next, they will learn about Voicing My CHOiCES . This guide gives people a place to say what kind of care they want to receive during their treatment and includes a place to document how they would want to be cared for if they can no longer make decisions on their own. Participants will be guided as they fill in a few pages from this guide.
The third conversation will review the first talks. Participants may ask questions and review any topic. They will complete follow-up questionnaires and be provided with a summary of their care priorities revealed in the discussions. They will be asked about their experience participating in this study, and their comfort with ACP discussions. They will be asked what they think of the meaningfulness, timing, and cultural sensitivity of these talks....