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

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....

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Behavioral: Advance Care Planning conversations

Detailed Description

Background:

• Allogeneic hematopoietic stem cell transplantation (HSCT) carries a significant risk of morbidity and mortality with adolescent and young adult (AYA) patients at inherently high cumulative risk of a myriad of late effects.
• Participation in advance care planning (ACP) is crucial to promoting patient-centered care and has been shown to have positive impacts on patients, caregivers, and providers. Many barriers exist in the engagement of AYAs and HSCT recipients in ACP conversations, including provider discomfort.
• A recent retrospective review of AYA patients that received an HSCT at the NIH Clinical Center (CC) in the past 5 years identified patterns of documented ACP discussions. The study revealed that very few patients engaged in ACP discussions beyond completion of an advance directive or physician completion of a medical order. Moreover, the majority of all ACP occurred in patients that ultimately died post-HSCT with most conversations occurring in the last days and weeks of life. Documentation of conversations was scattered throughout many different note types within the electronic medical record.

Objective:

-Assess the feasibility and acceptability of a series of longitudinal conversations about ACP topics with AYA HSCT recipients and their caregivers presenting to the Clinical Center for HSCT.

Eligibility:

AYA Participants:

Age: 18 through 39 years

English-speaking

Planned HSCT at a participating site

Caregiver Participants:

Age: >= 18

English-speaking

Identified as a caregiver by participating AYA participant

Provider Participants:

Primary clinical attending and 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.

Design:

This study consists of a baseline and follow-up assessments, and 3 conversation time points. For each participant, all conversations must be conducted by the same interviewer, excluding the final qualitative interview.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Wiener, Ph.D.; Phone Number: (240) 760-6419; Email: lori.wiener@nih.gov
• Study Contact Backup: Name: Brian W Pennarola, M.D.; Phone Number: (301) 451-9148; Email: brian.pennarola@nih.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Brian Pennarola, MD; Phone Number: Not Listed; Email: bpennar1@jhmi.edu
      • Contact: Heather Symons; Phone Number: (443) 287-2949; Email: hsymons@jhmi.edu
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office; Phone Number: 888-624-1937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 / Assessments and Conversation; Baseline and follow-up assessments and conversations at three timepoints	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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of ratings	AYA-caregiver dyad responses to the Life Priorities Survey; the difference between an AYA and caregiver dyad s ratings will be calculated for each individual goal (difference between 0 and 4) and for the total 9 goals combined (difference between 0 and 36). Pre-post differences in individual respondent ratings will be analyzed using paired t-tests or Wilcoxon signed rank tests as appropriate.	Baseline (Week 0), Follow-up (Week 4-9)
Communication quality	AYA and caregiver scores on the Serious Illness Communication Quality Questionnaire-HSCT; Mean scores on the Serious Illness Communication Quality Questionnaire - HSCT (minimum to maximum score, 11 - 55) will be compared between baseline and follow up, using paired samples t-tests. A separate McNemar test will be conducted for item #1 in this questionnaire 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)
Concordance of rankings	AYA-caregiver dyad responses to the Life Priorities Survey; the total number of shared ranked goals between an AYA and caregiver dyad (between 0 and 5) will be compared at baseline and follow-up, using paired t-tests, to determine if participation in the study significantly decreases incongruence between AYA and caregiver rankings	Baseline (Week 0), Follow-up (Week 4-9)

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lori Wiener, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): June 19, 2024
• Study Completion (Estimated): June 19, 2024

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: September 6, 2023

More Information

Terms related to this study

• Keywords: Palliative Care; Communication; Psychosocial; Goals Of Care; Voicing My Choices
• Other Study ID Numbers: 10001056; 001056-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All collected IPD will be shared.
• IPD Sharing Time Frame: Data from this study may be requested from other researchers after the completion of the primary endpoint.
• IPD Sharing Access Criteria: Data from this study may be requested by contacting the PI or Lead AI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No