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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001056-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

Yes

Population Exclusion(s)

Non-English Speaking;
Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Hematopoietic Stem Cell Transplantation

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Advance Care Planning conversations

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

-AYA Participants:

--Age >= 18 to <= 39 years

--Planned allogeneic HSCT at a participating site. Note: For participants at NIH only, enrollment on another NIH protocol for the HSCT is also required.

--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:

Either primary clinical attending or advance practice providers (APPs) at the NIH Clinical Center 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lori Wiener, Ph.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 1-6466
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6419
lori.wiener@nih.gov

Brian W. Pennarola, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 1C129C
10 CENTER DR
BETHESDA MD 20892
(203) 994-4558
brian.pennarola@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT05605574

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