Hematopoietic Stem Cell TransplantationNCT05605574
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
A study testing Advance Care Planning conversations in people with Hematopoietic Stem Cell Transplantation, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Advance Care Planning conversations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the 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 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:
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.
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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Advance Care Planning conversations
- Keywords
- Communication, Goals Of Care, Voicing My Choices, Palliative Care, Psychosocial
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning conversationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 / Assessments and Conversation | Experimental | Baseline and follow-up assessments and conversations at three timepoints Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week 10
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Baseline (Week 0), Follow-up (Week 4-9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start16 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brian W Pennarola, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605574
- Sponsor's protocol ID
- 10001056
- Other IDs
- 001056-C
- Status last verified
- 13 Oct 2026
- First submitted
- 3 Nov 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05605574
- Acronym / sponsor ID
- 10001056
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Communication, Goals Of Care, Voicing My Choices, Palliative Care, Psychosocial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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 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:
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 / Assessments and Conversation | Experimental | Behavioral: Advance Care Planning conversationsBaseline and follow-up assessments and conversations at three timepoints |
| 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- AYA Participants:
- Caregiver Participants:
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning conversationsIn 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. | Behavioural | 1 / Assessments and Conversation |
Primary outcome
Acceptability, Timing of intervention
Time frame: Follow-up (Week 4-9)
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.
Feasibility, Retention
Time frame: Week 9
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).
Acceptability, Emotional impact of intervention
Time frame: Baseline (Week 0), Follow-up (Week 4-9)
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.
Acceptability, qualitative interview
Time frame: Week 10
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.
3 secondary outcomes
Concordance of ratings
Time frame: Baseline (Week 0), Follow-up (Week 4-9)
Communication quality
Time frame: Baseline (Week 0), Follow-up (Week 4-9)
Concordance of rankings
Time frame: Baseline (Week 0), Follow-up (Week 4-9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared.
Related trials for Hematopoietic Stem Cell Transplantation
Active, not recruitingPhase 2
Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency
DOCK8 Deficiency
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
A Long-term Follow-up Study in Participants Who Received CS-101
Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian W Pennarola, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning conversations in people with Hematopoietic Stem Cell Transplantation, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability, Timing of intervention (time frame: Follow-up (Week 4-9)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.