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

NCT05605574 | Recruiting

• 2 other identifiers: 10001056001056-C
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Acceptability, Timing of intervention

  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.

  Follow-up (Week 4-9)

• Feasibility, Retention

  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).

  Week 9

• Acceptability, Emotional impact of intervention

  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.

  Baseline (Week 0), Follow-up (Week 4-9)

• Acceptability, qualitative interview

  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.

  Week 10

Secondary Outcomes (3)

• Concordance of ratings

  Baseline (Week 0), Follow-up (Week 4-9)

• Communication quality

  Baseline (Week 0), Follow-up (Week 4-9)

• Concordance of rankings

  Baseline (Week 0), Follow-up (Week 4-9)

Study Arms (2)

1 / Assessments and Conversation

EXPERIMENTAL

Baseline and follow-up assessments and conversations at three timepoints

Behavioral: Advance Care Planning conversations

2 / Survey

NO INTERVENTION

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 BEHAVIORAL

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.

1 / Assessments and Conversation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lori S Wiener, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian W Pennarola, M.D.

CONTACT

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

Lori S Wiener, Ph.D.

CONTACT

(240) 760-6419; wienerl@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 4, 2022
• Study Start: November 16, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-12-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data from this study may be requested from other researchers after the completion of the primary endpoint.
• Access Criteria: Data from this study may be requested by contacting the PI or Lead AI.

Locations

US (2)