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LEADD Program for Adolescents and Young Adults Undergoing Stem Cell Transplant

This study, called the Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program, is exploring whether adolescents and young adults (AYAs) receiving a hematopoietic stem cell transplant (HSCT) and their caregivers benefit from early discussions about their care. HSCT is a life-saving treatment, but it comes with risks. Advance Care Planning (ACP) conversations help patients and their families share their values and goals for care. This study will use a modified Serious Illness Conversation Guide to help patients and caregivers talk about their understanding of the illness, treatment, goals, and fears. The study aims to see if these conversations are acceptable and feasible for patients and families, and to understand their emotional impact. We are looking for 222 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 222 participants aged 18 to 39 who are planning to receive an allogeneic HSCT.
What's involved
Participants will engage in Advance Care Planning conversations. Acceptability and emotional impact will be measured at the start of the study and again at 4-9 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at Week 4-9 for acceptability and emotional impact, and at Week 9 for feasibility and retention.

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NCT05605574

Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant

Recruiting
NAAges 18+InterventionalSupportive care
National Cancer Institute (NCI)
~222 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Advance Care Planning conversations

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability, Timing of intervention
Measured over Follow-up (Week 4-9)
+3 more outcomes measured

Conditions

Hematopoietic Stem Cell Transplantation

Explore related trials

Hematopoietic Cell Transplantation

Where it's being run

2 sites across 1 states
Maryland2

Study leadership

  • Brian W Pennarola, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Brian W Pennarola, M.D.
[email protected]
(240) 760-7250
Email the study team

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Eligibility criteria

Inclusion

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:

What this trial measures

  • Acceptability, Timing of interventionFollow-up (Week 4-9)

    AYA and caregiver responses to items 2-3 on the ACP Experiences and Comfort Questionnaire; follow-up timepoint ratings of 1-2 on Likert scale (corresponding to agreement that ACP discussions are moderately or extremely important and should occur prior to transplant) reflect acceptability of the timing of the intervention.

  • Feasibility, RetentionWeek 9

    Target retention rate of 80% of participants for the 8 weeks of the study period (excluding those taken off study due to incapacitation or death).

  • Acceptability, Emotional impact of interventionBaseline (Week 0), Follow-up (Week 4-9)

    AYA and caregiver responses to ACP Experiences and Comfort Questionnaire; mean scores on items (7) and (8) will be compared between baseline and follow up, using paired samples t-tests. Separate chi square analyses will be conducted for sub-items in item (8) to assess if more participants agree (either agree or strongly agree ) or do not agree with the statement at follow-up compared to baseline.

  • Acceptability, qualitative interviewWeek 10

    Using a grounded theory approach, semi-structured interviews with AYAs and caregivers will be coded and analyzed to explore perceptions of the timing, appropriateness, and meaningfulness of the intervention.