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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial helps young adults and their caregivers navigate the emotional and practical challenges of a bone marrow transplant. It focuses on meaningful conversations about personal values and care preferences before and during the transplant process. Participants will engage in guided discussions, known as Advance Care Planning conversations, to explore their priorities and document their care wishes. The trial seeks young adults aged 18 to 39 planning to undergo a bone marrow transplant, along with one caregiver. This process aims to align the care they receive with what matters most to them. As an unphased trial, it offers a unique opportunity for participants to shape their care experience according to their personal values.

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 prior data suggests that these advance care planning discussions are safe for bone marrow transplant patients?

Research has shown that discussing advance care planning (ACP) is generally safe for participants. These conversations enable patients to communicate their healthcare wishes to family and healthcare providers. No evidence suggests any physical risks from these discussions.

Studies have found that ACP can lead to better outcomes by ensuring patients' preferences are known and respected. This becomes especially important during serious illnesses, such as when a bone marrow transplant is needed. Although these talks might address emotional topics, they aim to be supportive and helpful. Participants often feel more prepared and at ease afterward.

Overall, ACP is a well-accepted process that aligns medical care with what patients value most. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about advance care planning conversations for bone marrow transplant patients because they aim to improve communication and decision-making between patients, caregivers, and healthcare providers. Unlike standard medical treatments, which focus on physical healing, these conversations provide emotional and psychological support, helping patients better understand their options and align their medical care with personal values. This approach is unique because it fosters a holistic view of patient care, potentially improving overall patient satisfaction and outcomes during challenging treatment periods.

What evidence suggests that advance care planning conversations are effective for bone marrow transplant patients?

Research has shown that discussing advance care planning (ACP) greatly benefits patients undergoing treatments like stem cell transplants. In this trial, participants will engage in assessments and conversations about ACP at three timepoints. Studies have found that early conversations can lead to better care and lower hospital costs. For instance, patients who discuss ACP often receive care aligned with their personal wishes and values. Initiating these talks early helps young adults and their caregivers feel more informed and prepared for the transplant process. These discussions can reduce stress and clarify treatment choices, focusing the entire experience on the patient's needs. ^{3 4 6 7 8}

Who Is on the Research Team?

Lori S Wiener, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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) 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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33161732/

Advanced Care Planning and End-of-life Outcomes in ...

The data also suggest that identification of patients who would most benefit from early engagement in ACP may positively impact outcomes.

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2833774

An Intervention to Increase Advance Care Planning Among ...

The results of this study suggest that implementing patient video decision aids along with bolstering clinician communication skills can improve clinical ACP ...

3.

asco.org

asco.org/abstracts-presentations/ABSTRACT137721

The value of advance care planning (ACP) in cancer ...

BMT-specific data was reviewed to establish the effect of early ADs on care and LOS. Results: Floor care proved to cost on average $2,000 less per day than ICU ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0885392425005202

Early Advance Care Planning in Young Adults Receiving ...

In this novel study introducing early ACP conversations to YA HSCT recipient/caregiver dyads, we report on participants' perceptions of important ACP topics.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10130676/

Incorporating transitional palliative care in a bone marrow ...

This case report showed our serious illness conversation program (SICP) could transit gradually a patient with bone marrow transplant (BMT) and palliative care ...

6.

jpsmjournal.com

jpsmjournal.com/article/S0885-3924(22)00866-1/fulltext

Advance Care Planning in Serious Illness: A Narrative ...

Advance care planning (ACP) intends to support person-centered medical decision-making by eliciting patient preferences.

7.

ascopubs.org

ascopubs.org/doi/10.1200/JOP.2017.026930

Advance Care Planning and Palliative Care Specialists in ...

As a consequence, advance care planning is frequently overlooked in malignant hematology, because we maintain our sights on the cure.

8.

astctjournal.org

astctjournal.org/article/S1083-8791(19)31514-9/fulltext

Advance Care Planning in Hematopoietic Stem Cell ...

Advance care planning (ACP) includes having conversations with loved ones and health care providers regarding health care wishes in various circumstances.