Group Advance Care Planning for Cancer

Overseen By Manali I Patel, MD MPH MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Inability to consent, Moving, others

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

Compensation: Varies

Number of Visits: 2

50 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 Group Advance Care Planning Education for cancer?

Research shows that advance care planning (ACP) helps ensure that patients' end-of-life wishes are followed, increases satisfaction for both patients and families, and reduces stress, anxiety, and depression for families. This suggests that group ACP education could be beneficial for cancer patients by improving communication and decision-making about future health care. ^{1 2 3 4 5}

Is Group Advance Care Planning generally safe for humans?

There is no specific safety data available for Group Advance Care Planning, but non-drug trials in palliative care, like this one, often focus on managing serious adverse events, which can include psychological distress. These events are usually related to the progression of the disease rather than the trial itself. ^{6 7 8 9 10}

How is the Group Advance Care Planning Education treatment different from other treatments for cancer?

Group Advance Care Planning Education is unique because it focuses on helping patients with cancer plan their future healthcare decisions, improving communication and aligning care with their wishes, rather than directly treating the cancer itself. This approach is particularly beneficial for older adults who often face barriers to completing advance care planning. ^{11 12 13 14 15}

What is the purpose of this trial?

The proposed research aims to engage participants with an advanced stage cancer diagnosis in group educational sessions to facilitate learning of topics related to advanced care planning. The investigators also hope to learn if conducting educational sessions in a group setting helps to create a more supportive environment amongst patients, caregivers, etc.

Eligibility Criteria

This trial is for veterans with an advanced stage cancer diagnosis. It's designed to help them learn about advanced care planning through group educational sessions, which may also provide a supportive environment.

Inclusion Criteria

2. Patients must have the ability to understand and willingness to provide verbal consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in group advanced care planning sessions or receive usual care

8 weeks

2 sessions (in-person or virtual)

Follow-up

Participants are monitored for documentation of goals of care and other secondary outcomes

8 weeks

Treatment Details

Interventions

• Group Advance Care Planning Education

Trial Overview The intervention being studied is Group Advance Care Planning Education. The goal is to see if learning in a group setting can improve understanding and support among patients and caregivers dealing with advanced cancer.

Participant Groups

Group I: Group Advance Care Planning Experimental Treatment 1 Intervention

The participant will engage in 2 hours of educational sessions regarding advance care planning and goals of care. They will be interviewed which is expected to last 20-30 min and surveys will last 15-20 min. The total involvement will be no more than 3 hours and 40 min over 8 weeks.

Group II: Usual Care Active Control 1 Intervention

The patient will continue to receive as normal and usual. The participants will be interviewed which is expected to last 20-30 min. Surveys will last 15-20 min. The total possible time is 1 hour and 40 min. for both baseline and post over 8 week period.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

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 456 patients with terminal cancer, only 6% had documented care goals in case of acute deterioration, highlighting a significant gap in advance care planning.

A quality improvement initiative was launched to enhance documentation and referral rates to palliative care, aiming to ensure better patient support and care planning in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward improved goals-of-care documentation in advanced cancer: report on the development of a quality improvement initiative. Harle, I., Karim, S., Raskin, W., et al.[2022]

A significant number of health professionals (62.5% in primary care and 72.5% in hospitals) reported experiencing emotional distress as 'second victims' after adverse events, indicating a widespread impact on their mental well-being.

Feelings of guilt, anxiety, and insecurity were the most common emotional responses among these professionals, highlighting the need for better training and support systems to help them cope with the psychological effects of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The aftermath of adverse events in Spanish primary care and hospital health professionals. Mira, JJ., Carrillo, I., Lorenzo, S., et al.[2022]

A total of 417 adverse event cases leading to death were reported in Brazil from June 2014 to June 2016, primarily affecting adults and the elderly, with hospitals being responsible for 97% of these cases.

The most common incidents were categorized as 'failures during health care,' highlighting a significant need for improved reporting and investigation of such events, as only 5% of cases were further investigated by the notifying units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registry of adverse events related to health care that results in deaths in Brazil, 2014-2016. Maia, CS., Freitas, DRC., Gallo, LG., et al.[2019]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

The study aims to improve advance care planning (ACP) for older patients with advanced cancer through a Comprehensive ACP Program that includes clinician communication training and patient video decision aids, implemented across 36 oncology clinics with an estimated 11,000 participants.

The primary goal is to increase the completion rate of ACP documentation in electronic health records, which is crucial for enhancing health outcomes for patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. Lakin, JR., Brannen, EN., Tulsky, JA., et al.[2021]

The PREPARE for Your Care website, combined with an easy-to-read advance directive, significantly increased advance care planning (ACP) documentation among older adults with cancer (62% vs 43%) and those without cancer (38% vs 28%) compared to using an advance directive alone.

Engagement in ACP through the PREPARE program did not lead to increased levels of depression or anxiety, indicating that it is a safe and effective tool for improving ACP among diverse older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PREPARE for Your Care program increases advance care planning engagement among diverse older adults with cancer. Nouri, SS., Barnes, DE., Shi, Y., et al.[2022]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial. [2019]

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

Can a patient-directed video improve inpatient advance care planning? A prospective pre-post cohort study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Medical oncology outpatients' preferences and experiences with advanced care planning: a cross-sectional study. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Toward improved goals-of-care documentation in advanced cancer: report on the development of a quality improvement initiative. [2022]

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

An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. [2023]

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

One fourth of unplanned transfers to a higher level of care are associated with a highly preventable adverse event: a patient record review in six Belgian hospitals. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The aftermath of adverse events in Spanish primary care and hospital health professionals. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Registry of adverse events related to health care that results in deaths in Brazil, 2014-2016. [2019]

10. England pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. [2021]

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

The PREPARE for Your Care program increases advance care planning engagement among diverse older adults with cancer. [2022]

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

Is an advance care planning model feasible in community palliative care? A multi-site action research approach. [2019]

14. England pubmed.ncbi.nlm.nih.gov

The economic evidence for advance care planning: Systematic review of evidence. [2018]

15. England pubmed.ncbi.nlm.nih.gov

Effects of an advance care planning educational programme intervention on the end-of-life care attitudes of multidisciplinary practitioners at an acute hospital: A pre- and post-study. [2020]