Recruiting

LEADD Program

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05605574

Conditions

Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Advance Care Planning conversations

Study Details

Brief summary:

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....

Conditions

Hematopoietic Stem Cell Transplantation

Study ID

NCT05605574

Start date

Nov 16, 2022

Status verified date

Jul 14, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

222 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 1 / Assessments and Conversation

Baseline and follow-up assessments and conversations at three timepoints

no intervention: 2 / Survey

Following each AYA/caregiver dyad s completion of timepoint 3, a one-time survey will be sent to a primary clinical attending and APPs who cared for the AYA during the study period

Interventions

Advance Care Planning conversations

In the first conversation, patients and caregivers are guided through conversations using a modified version of the Serious Illness Conversation Guide, which explores understanding of the AYA's illness and treatment plan, information preferences, goals, sources of support, fears and worries, and goals of care. In the second conversation, participants are introduced to and encouraged to complete portions of the advance care planning document, Voicing My CHOiCES. Participants are guided through a discussion of this experience and may share their perceptions of each other's preferences for care. In the third conversation, participants may discuss previous conversations or other new Advance Care Planning topics. At the end of each conversation, a summary of the conversation will be documented in the electronic medical record and the investigator will communicate directly any information requested by the patient or caregiver to be shared with specific members of the patient's care team.

Primary outcome measure

  • Acceptability, Timing of intervention [ Time Frame: Follow-up (Week 4-9) ]
  • Feasibility, Retention [ Time Frame: Week 9 ]
  • Acceptability, Emotional impact of intervention [ Time Frame: Baseline (Week 0), Follow-up (Week 4-9) ]
  • Acceptability, qualitative interview [ Time Frame: Week 10 ]

Central Contacts and Locations

Central contacts

Brian W Pennarola, M.D.

(240) 760-7250brian.pennarola@nih.gov

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Brian Pennarola, MD

Not Listedbpennar1@jhmi.edu

Heather Symons

(443) 287-2949hsymons@jhmi.edu

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Jul 16, 2026

Last verified

Jul 14, 2026

Keywords

  • Communication
  • Goals Of Care
  • Voicing My Choices
  • Palliative Care
  • Psychosocial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-07-16.