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

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Lori S Wiener, Ph.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-16

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations