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

300 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Post-Mortem Plan, Project Debrief, Retrospective, Project Recap, Wrap-Up Meeting, Lessons Learned Meeting for end-of-life planning for cancer?

The research highlights the importance of improving end-of-life care by focusing on quality and symptom management, which are key components of effective end-of-life planning. This suggests that structured planning and review processes, like those in the treatment, can enhance the quality of care for patients at the end of life. ^{1 2 3 4 5}

Is the end-of-life planning treatment generally safe for humans?

The research articles provided do not contain specific safety data for the end-of-life planning treatment or its related names. They focus on safety monitoring and adverse event reviews in clinical settings, but not directly on the safety of this specific treatment. ^{6 7 8 9 10}

Is the treatment in the trial 'End-of-Life Planning for Cancer' a promising treatment?

Yes, end-of-life planning for cancer is a promising treatment because it helps ensure that care aligns with patients' values, improves awareness and access to care, and enhances the experience for patients and their families during the final stages of life. ^{11 12 13 14 15}

What is the purpose of this trial?

The proposed research consists of engagements with terminal cancer patients and their friends and family as they engage in end-of-life planning.

Research Team

Jed Brubaker

Principal Investigator

University of Colorado, Boulder

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of a patient/family-centered practice change on the quality and cost of intensive care: research protocol. [2015]

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

Palliative care at the end of life: comparing quality in diverse settings. [2019]

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

Use of the quality improvement process in assessing end-of-life care in the nursing home. [2006]

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

Use of the quality improvement process in assessing end-of-life care in the nursing home. [2015]

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

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

6. Canada pubmed.ncbi.nlm.nih.gov

Aiming for zero preventable deaths: using death review to improve care and reduce harm. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating and implementing data and safety monitoring plans. [2016]

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

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

9. Spain pubmed.ncbi.nlm.nih.gov

[Consensus conference on providing information of adverse events to patients and relatives]. [2015]

10. England 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. [2023]

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

Social and healthcare professionals' experiences of end-of-life care planning and documentation in palliative care. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Symptoms, treatment and "dying peacefully" in terminally ill cancer patients: a prospective study. [2018]

13. England pubmed.ncbi.nlm.nih.gov

End-of-life transitions for family member on the solid tumour oncology ward: the 3 Wishes Project. [2021]

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

End-of-life content in Comprehensive Cancer Control Plans: a systematic review. [2023]

15. England 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. [2023]