An interventional study of Advance Care Planning conversations in Hematopoietic Stem Cell Transplantation, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Supportive care
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....
Background:
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's enrollment of 35 is below the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
AYA Participants:
Caregiver 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.
EXCLUSION CRITERIA:
None.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Baseline and follow-up assessments and conversations at three timepoints
Behavioral: Advance Care Planning conversations
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
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 10
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.
Time frame: 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
Time frame: 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
Time frame: Baseline (Week 0), Follow-up (Week 4-9)
Plan to share: Yes — All collected IPD will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2026, 49 months after the start.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 49 months is above that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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