End-of-Life Planning for Cancer

Overseen By Jed Brubaker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with terminal cancer and their loved ones plan for life after the patient's passing. The goal is to support and guide families through the planning process and evaluate the effectiveness of their plans after the patient's death. Researchers seek to improve these plans and understand any challenges that arise. This trial suits adults with advanced cancer and their family members who are open to participating in these planning activities, including developing a Post-Mortem Plan. As an unphased trial, it offers families a unique opportunity to contribute to meaningful research that can enhance end-of-life planning for others.

Do I need to stop taking my current medications for this trial?

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

What prior data suggests that this end-of-life planning method is safe for participants and their families?

Research has shown that the Post-Mortem Plan aids terminal cancer patients and their families with end-of-life planning. Specific safety data is unavailable because it is not a medical treatment or drug. Instead, it serves as a supportive process for families after a loved one's passing.

This process emphasizes planning and communication rather than medical procedures. It aims to ease the difficult period following a loss. Since it involves no medication or surgery, there is no risk of physical harm. The focus is on providing emotional support and ensuring the deceased's wishes are honored.

In summary, without involving medical treatments, the Post-Mortem Plan is safe. It offers guidance and support during a challenging time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it addresses an often overlooked aspect of cancer care: end-of-life planning. Unlike traditional cancer treatments, which focus on managing symptoms or slowing disease progression, the Post-Mortem Plan centers on supporting the patient's network after death. This approach aims to provide emotional support to grieving loved ones while also identifying systemic challenges and improving post-mortem planning processes. This holistic method is unique because it extends care beyond the patient, offering a compassionate framework that acknowledges the broader impact of terminal illness on families and communities.

What evidence suggests that the Post-Mortem Plan is effective for end-of-life planning in cancer patients?

Research shows that planning for the end of life helps people with terminal cancer feel more in control. Studies have found that advance care planning improves experiences at the end of life, easing the process for patients and families to manage final wishes. In this trial, the Post-Mortem Plan ensures these wishes are respected after death. This process identifies what went well and what could be improved, serving as a useful tool for ongoing improvement. The approach also supports grieving families and friends, providing comfort during a difficult time. ^{1 2 6 7 8}

Who Is on the Research Team?

Jed Brubaker

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

This trial is for adults with metastatic cancer who have online accounts and data, as well as their adult family or friends willing to participate in end-of-life planning activities. There are no specific exclusion criteria listed.

Inclusion Criteria

Life-limited adults diagnosed with metastatic cancer who have online accounts and data

Adult family/loved ones of the diagnosed adult who are willing to participate in planning activities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Engagement and Planning

Participants engage in interviews to identify end-of-life needs and wishes, and develop post-mortem plans.

Varies based on participant needs

Multiple visits (in-person or virtual)

Implementation and Support

Participants and their networks perform tasks to implement the post-mortem plan, with support from the study team.

Ongoing

Regular check-ins based on participant preferences

Follow-up

Participants are monitored for changes in social and technical circumstances, with ongoing support provided.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Post-Mortem Plan

Trial Overview The study focuses on the process of end-of-life planning concerning online accounts and data management for terminal cancer patients, involving their close ones in these preparations.

How Is the Trial Designed?

Group I: Post-Mortem Plan Experimental Treatment 1 Intervention

Following the death of the terminally ill participant, investigators will work with networks as the wishes of the deceased are executed. Continued engagement at this point will allow us to provide support to the network during a difficult period or time while also identifying shortcomings in our plans and systemic challenges to postmortem planning. Working with those who are grieving is a delicate proposition, but one with which my students and I have extensive experience.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

U.S. National Science Foundation

Collaborator

Trials

35

Recruited

9,000+

Published Research Related to This Trial

The Death and Adverse Event Review process, implemented to achieve zero preventable deaths, has effectively identified adverse events (AEs) in 1,817 patient deaths, with rates of 12.1% and 16.3% for AEs and quality of care issues, respectively.

This review process has led to actionable recommendations for improvement, resulting in system-wide changes such as enhanced physician documentation standards and revised post-operative guidelines, contributing to ongoing efforts to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aiming for zero preventable deaths: using death review to improve care and reduce harm. Zimmerman, R., Pierson, S., McLean, R., et al.[2019]

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. Allan, MC.[2019]

Healthcare professionals identified a significant gap between the ideal proactive, patient-oriented end-of-life (EOL) care planning and the actual documentation capabilities in electronic health records (EHR), highlighting challenges in effectively recording and accessing important care plans.

The study revealed that while structured documentation is beneficial, the current EHR systems do not adequately support the multi-professional documentation needed for comprehensive EOL care, indicating a need for improved technological solutions in palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social and healthcare professionals' experiences of end-of-life care planning and documentation in palliative care. Kuusisto, A., Saranto, K., Korhonen, P., et al.[2023]

Data and safety monitoring plans are crucial in clinical trials to ensure patient safety and to provide transparency about risks, helping participants make informed decisions about their involvement.

These plans involve independent oversight, regular data collection, and active surveillance for adverse events, ensuring that any potential risks are managed effectively throughout all phases of the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating and implementing data and safety monitoring plans. Terrin, ML.[2016]

A quality improvement project at the Thomas Fitzgerald State Veterans Home led to significant enhancements in end-of-life care, including a 22% reduction in pain, 25% in dyspnea, and 30% in other uncomfortable symptoms, as reported by representatives of the deceased.

The project highlighted the importance of interdisciplinary teamwork and patient representative surveys in identifying areas for improvement, resulting in better overall quality of care and spiritual support, although challenges remained in managing emotional issues like depression and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the quality improvement process in assessing end-of-life care in the nursing home. Vandenberg, EV., Tvrdik, A., Keller, BK.[2015]

The consensus conference developed key recommendations for improving the disclosure of adverse events to patients and their families, emphasizing the need for institutional policies and guidelines.

Training healthcare professionals in communication skills and patient safety is crucial, along with creating supportive strategies for those involved in adverse events, to foster a culture of transparency and trust in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Consensus conference on providing information of adverse events to patients and relatives]. Martín-Delgado, MC., Fernández-Maillo, M., Bañeres-Amella, J., et al.[2015]

In a study of 118 patients who died from terminal malignant diseases over eight years, 75% received care from their general practitioners (GPs) at the time of death, indicating effective continuity of care in palliative settings.

The care provided was generally assessed as 'satisfactory' for the patients, suggesting that regular audits and monitoring can help maintain high standards in palliative care, encouraging GPs to keep detailed records for quality assurance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditing palliative care in one general practice over eight years. Holden, JD.[2019]

The 3 Wishes Project (3WP) was successfully implemented in an oncology ward, where it facilitated the fulfillment of 175 final wishes for 52 cancer patients, significantly enhancing the end-of-life experience for both patients and their families.

Qualitative interviews with family members indicated that the 3WP helped ease transitions during the end-of-life process, allowing families to shift from a caregiver role to a more personal connection and focus on creating lasting legacies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-of-life transitions for family member on the solid tumour oncology ward: the 3 Wishes Project. Day, G., Bear, D., Swinton, M., et al.[2021]

A systematic review of 45 Comprehensive Cancer Control (CCC) Plans revealed that 91% included the keyword 'end-of-life,' indicating a strong recognition of EOL issues in cancer care.

The most common EOL goals focused on care usage, access to care, and raising awareness, with strategies emphasizing research and education for both providers and the public, which can enhance future CCC planning efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-of-life content in Comprehensive Cancer Control Plans: a systematic review. Theis, KA., Rao, JK., Anderson, LA., et al.[2023]

In a study of 200 patients with advanced non-small cell lung cancer, specific elements of end-of-life discussions (like prognosis and hospice preferences) did not significantly impact patients' quality of life or the actual care they received at the end of life.

However, the compassion shown by oncologists was linked to improvements in patients' quality of life and depressive symptoms, suggesting that the emotional support from healthcare providers plays a crucial role in end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elements of End-of-Life Discussions Associated With Patients' Reported Outcomes and Actual End-of-Life Care in Patients With Pretreated Lung Cancer. Hasegawa, T., Okuyama, T., Uemura, T., et al.[2023]

The study aims to evaluate a patient/family-centered practice change in a Medical Intensive Care Unit, focusing on improving communication within 72 hours of patient admission, which is expected to enhance care quality and reduce costs for critically ill patients at the end of life.

The research design includes a two-group post-test comparison of families' experiences before and after the practice change, utilizing medical records and surveys to assess the impact, ensuring that the interventions are directly applicable to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient/family-centered practice change on the quality and cost of intensive care: research protocol. Radwin, LE., Ananian, L., Cabral, HJ., et al.[2015]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[2023]

A quality improvement project reviewed the care of 195 patients who died over six months, highlighting that pain and other symptoms were often poorly managed at the end of life.

The study found widespread symptom distress and frequent use of diagnostic and therapeutic procedures in the last 48 hours, indicating significant areas for improvement in end-of-life care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care at the end of life: comparing quality in diverse settings. Paice, JA., Muir, JC., Shott, S.[2019]

A quality improvement project at the Thomas Fitzgerald State Veterans Home led to significant enhancements in end-of-life care, including a 22% reduction in pain, 25% in dyspnea, and 30% in other uncomfortable symptoms, as reported by representatives of the deceased.

The project highlighted the importance of interdisciplinary teamwork and patient representative surveys in identifying areas for improvement, resulting in better overall quality of care and spiritual support, although challenges remained in managing emotional issues like depression and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the quality improvement process in assessing end-of-life care in the nursing home. Vandenberg, EV., Tvrdik, A., Keller, BK.[2006]

Terminally ill cancer patients experience a range of symptoms in their final months, with fatigue, loss of appetite, and dependency being the most common, highlighting the need for effective symptom management.

While physical symptoms were more frequently treated than psychosocial ones, a peaceful death was associated with the presence of family, particularly children, indicating that emotional support is crucial for improving the quality of life at the end of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms, treatment and "dying peacefully" in terminally ill cancer patients: a prospective study. Georges, JJ., Onwuteaka-Philipsen, BD., van der Heide, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2606925/

End of Life Planning and its Relevance for Patients ... The goal of end of life (EoL) planning is to provide individuals with tools to control their financial and health care decisions when they are incapacitated.

2. cdlib.org cdlib.org/cdlinfo/2010/11/17/the-project-post-mortem-a-valuable-tool-for-continuous-improvement/

The Project Post-Mortem: A Valuable Tool for Continuous ... A post-mortem is generally conducted at the end of the entire project, but it is also useful at the end of each phase of a multi-phase project.

3. withpower.com withpower.com/trial/phase-neoplasm-metastasis-8-2021-bd823

End-of-Life Planning for Cancer · Info for Participants What data supports the effectiveness of the treatment Post-Mortem Plan, Project Debrief, Retrospective, Project Recap, Wrap-Up Meeting, Lessons Learned Meeting ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405694/

Evaluating outcomes of advance care planning interventions ... The effectiveness of advance care planning in improving end-of-life outcomes ... end-of-life cancer care: a systematic review. Palliat Support ...

5. plan.io plan.io/blog/post-mortem-meeting/

How to run a successful post-mortem meeting (with ... A project post-mortem meeting is a meeting held after a project is completed to identify what went well and what could be improved for the future.

6. asana.com asana.com/resources/project-post-mortem-tips

6 Steps for a Successful Project Postmortem Meeting A project postmortem meeting reflects on how the project went and identifies what can be changed moving forward to create a more streamlined ...

7. parabol.co parabol.co/blog/how-to-run-a-post-mortem/

How to Run a Post-Mortem Meeting: Easy 6-Step Process A post-mortem meeting is a team workshop for reflecting on a failed project or significant incident.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5603282/

Outcomes for End-of-Life Patients with Anticipatory Grieving The purpose of our study was to examine the outcomes of hospitalized end-of-life patients with anticipatory grief.