Advance Care Planning Discussions for Bone Marrow Transplant Patients

Recruiting at 1 trial location

Overseen By Lori S Wiener, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

222 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Advance Care Planning conversations for Bone Marrow Transplant Patients?

Research shows that Advance Care Planning (ACP) helps ensure that patients' end-of-life wishes are followed, improves quality of care, and reduces stress and anxiety for patients and their families. This has been observed in various patient groups, including those with cancer and intellectual disabilities. ^{1 2 3 4 5}

Is advance care planning safe for bone marrow transplant patients?

There is little evidence available on the safety of advance care planning (ACP), but it is generally considered a process to improve end-of-life care and patient satisfaction without specific safety concerns noted in the research. ^{1 2 6 7 8}

How is advance care planning unique for bone marrow transplant patients?

Advance care planning (ACP) for bone marrow transplant patients is unique because it focuses on preparing for potential outcomes of a high-risk, potentially curative procedure, ensuring that patients' wishes are documented and respected, especially given the high risks of decisional incapacity and death associated with the treatment. ^{2 3 7 9 10}

What is the purpose of this trial?

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....

Research Team

Lori S Wiener, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This study is for young adults aged 18 to 39 who are about to receive a bone marrow transplant and have enrolled in an NIH study. They must speak English and be able to give informed consent. A caregiver over the age of 18, identified by the patient, can also join. Healthcare providers involved in their care may participate too.

Inclusion Criteria

I am a caregiver and I speak English.

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

Caregiver Participants: Physically present at the participating site

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a 20-minute questionnaire about their care priorities and prior experiences with ACP.

1 week

1 visit (in-person or virtual)

Conversations

Participants engage in 3 conversations over 4 to 9 weeks discussing their upcoming transplant, expectations, fears, and care preferences.

4-9 weeks

3 visits (in-person or virtual)

Follow-up

Participants complete follow-up questionnaires and a qualitative interview to assess the acceptability and emotional impact of the intervention.

1-2 weeks

1 visit (in-person or virtual)

Treatment Details

Interventions

• Advance Care Planning conversations

Trial Overview The trial explores whether discussions on advance care planning (ACP) benefit young patients undergoing stem cell transplants and their caregivers. It involves completing questionnaires and having three detailed conversations about treatment expectations, personal values, support needs, and documenting care preferences.

Participant Groups

Group I: 1 / Assessments and Conversation Experimental Treatment 1 Intervention

Baseline and follow-up assessments and conversations at three timepoints

Group II: 2 / Survey Active Control 1 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 Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

Advance care planning (ACP) is crucial for enhancing the quality of end-of-life care for cancer patients, as it allows them to make informed decisions about their future health care in collaboration with healthcare providers and family.

Implementing ACP leads to better adherence to patients' end-of-life wishes, increased satisfaction for both patients and families, and a reduction in family-related stress, anxiety, and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advance Care Planning in Cancer Care]. Kizawa, Y., Yamaguchi, T., Yotani, N.[2016]

In a study of 343 adult patients undergoing their first hematopoietic stem-cell transplantation (HSCT), those who engaged in advance care planning (ACP) had a significantly lower risk of death compared to those who did not, with a hazard ratio of 2.11 indicating a more than double risk for non-ACP patients.

The majority of patients who completed ACP did so after their cancer diagnosis, suggesting that timely engagement in ACP may be crucial for improving outcomes in HSCT patients, highlighting the need for further research into how to encourage ACP in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after hematopoietic stem-cell transplantation for hematologic malignancies in patients with or without advance care planning. Ganti, AK., Lee, SJ., Vose, JM., et al.[2007]

Advance care planning (ACP) discussions are crucial for ensuring that patients with serious illnesses receive care that aligns with their goals, particularly at the end of life.

The study aims to clarify the effectiveness of ACP discussions, comparing early conversations in a patient's illness to those that occur later when specific medical decisions are needed, through a multisite initiative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning imperative: High-quality patient-centred goals of care. Case, AA., Epstein, AS., Gustin, JL.[2022]

Advance care planning (ACP) shows potential benefits for people with intellectual disabilities (IDs) in palliative care, but current research primarily reflects the views of professionals and relatives rather than the patients themselves.

Barriers to effective ACP include challenges in identifying palliative needs and uncertainties among caregivers, while positive relationships between professionals and families can facilitate the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning in Palliative Care for People With Intellectual Disabilities: A Systematic Review. Voss, H., Vogel, A., Wagemans, AMA., et al.[2023]

A survey of 118 oncologists revealed that while 72% engaged in advance care planning (ACP) with patients, only 33% used structured formats for these discussions, indicating a need for more standardized approaches.

The study found that improving end-of-life communication skills significantly increased physician engagement in ACP, highlighting the importance of training and education in enhancing these critical conversations with patients suffering from metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Advance Care Planning and End-of-life Communication for Patients with Advanced and Metastatic Breast Cancer. Sagara, Y., Mori, M., Yamamoto, S., et al.[2021]

A review of 70 patient safety incident reports related to advance care planning (ACP) revealed that 40% of incidents were due to ACP being completed but not communicated effectively among healthcare professionals.

The study highlighted that human factors, such as staff knowledge and confidence in ACP documentation, significantly impact the safety and effectiveness of ACP processes, leading to adverse outcomes like inappropriate treatments contrary to patient wishes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety incidents in advance care planning for serious illness: a mixed-methods analysis. Dinnen, T., Williams, H., Yardley, S., et al.[2022]

In a study of 601 patients who underwent hematopoietic stem-cell transplantation (HSCT), nearly all had their code status documented, but only 19% received palliative care consultations, indicating a gap in integrating advance care planning with HSCT treatment.

Most patients (85%) died in the hospital, and only 15% were enrolled in hospice care, highlighting the need for improved access to palliative care and advance directives in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Palliative Care Integration for Patients Undergoing Hematopoietic Stem-Cell Transplantation. Wang, WS., Ma, JD., Nelson, SH., et al.[2020]

Advance care planning (ACP) can improve quality of life and reduce unnecessary medical interventions, but Sweden lacks a systematic national strategy for its implementation in healthcare settings.

Successful ACP implementation in nursing homes requires strong organizational support, including training and collaboration among healthcare professionals, to ensure that residents' psychosocial needs are also addressed alongside medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing advance care planning in Swedish healthcare settings - a qualitative study of professionals' experiences. Beck, S., Lundblad, L., Göras, C., et al.[2023]

In a survey of 155 adult patients undergoing hematopoietic cell transplantation (HCT), 69% reported designating a health care proxy and 44% completed a living will, indicating a relatively high prevalence of advance care planning (ACP) compared to the general population.

Despite the prevalence of ACP elements among patients, only 16% had discussed their life support wishes with clinicians, highlighting a significant gap in clinician-patient communication regarding ACP in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning in patients undergoing hematopoietic cell transplantation. Joffe, S., Mello, MM., Cook, EF., et al.[2015]

In a study of 50 high-risk leukemia patients, only 16% received palliative care consultations despite a high symptom burden, indicating a significant gap in access to supportive care for this vulnerable group.

Only 24% of patients had complete advance care planning documentation, highlighting missed opportunities for addressing patient preferences and improving quality of care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Palliative Care Consultation and Advance Care Planning for Adults with High-Risk Leukemia. Freeman, AT., Wood, WA., Fox, A., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Advance Care Planning in Cancer Care]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes after hematopoietic stem-cell transplantation for hematologic malignancies in patients with or without advance care planning. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Advance care planning imperative: High-quality patient-centred goals of care. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Advance Care Planning in Palliative Care for People With Intellectual Disabilities: A Systematic Review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Current Status of Advance Care Planning and End-of-life Communication for Patients with Advanced and Metastatic Breast Cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Patient safety incidents in advance care planning for serious illness: a mixed-methods analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Palliative Care Integration for Patients Undergoing Hematopoietic Stem-Cell Transplantation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Implementing advance care planning in Swedish healthcare settings - a qualitative study of professionals' experiences. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Advance care planning in patients undergoing hematopoietic cell transplantation. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Access to Palliative Care Consultation and Advance Care Planning for Adults with High-Risk Leukemia. [2019]