Group Advance Care Planning for Cancer

Overseen By Madhuri Agrawal

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if group educational sessions about advance care planning (deciding on future medical care) are more effective than just receiving written materials. The goal is to assist people with newly diagnosed cancer in making informed decisions about their care. Participants will either continue with their usual care and receive some written information or attend group sessions to learn more about planning their future medical care. This trial suits English-speaking adults who have been recently diagnosed with cancer and can provide verbal consent. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance future care planning for cancer patients.

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 this group advance care planning education is safe?

Research shows that group advance care planning (ACP) education involves no drugs or medical procedures. It helps individuals plan their future medical care based on their personal values. While specific safety data for this type of education is lacking, similar studies in palliative care, which emphasize comfort, typically present very low risk. Participants often feel more prepared and supported when making important decisions about their care. This suggests that group ACP education is a safe and effective method for planning healthcare needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Group Advance Care Planning Education because it offers a fresh approach to cancer care by focusing on proactive communication and planning. Unlike traditional treatments that primarily concentrate on medical interventions, this method emphasizes empowering patients through education about their care options and goals. By engaging patients in group educational sessions, it encourages more open discussions and better understanding of individual care preferences, which may lead to improved patient satisfaction and quality of life. This approach could redefine how we support cancer patients, making the care process more personalized and aligned with their values.

What evidence suggests that Group Advance Care Planning Education is effective for cancer patients?

Research has shown that group sessions on advance care planning, which participants in this trial may receive, greatly help patients ensure their medical care aligns with their personal goals. Studies have found that this approach significantly increases the likelihood of completing advance directives, with participants more likely to prepare these important documents. Additionally, patients in these programs often communicate better and make more informed decisions about their future healthcare. Reviews indicate that advance care planning can lead to care that aligns more closely with patients' wishes. Overall, these findings suggest that group sessions serve as a valuable tool for patients in planning their care effectively. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 care. The participant will also receive educational materials in writing regarding advance care planning mailed to their preferred mailing address. The participants will complete surveys and interviews at baseline at again at 8 weeks post enrollment.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

VA Palo Alto Health Care System

Lead Sponsor

Trials

97

Recruited

58,500+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

ci2i

Collaborator

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Evaluating outcomes of advance care planning interventions ...

Fourteen reviews evidenced significant increases in patients receiving care consistent with their goals, and 12 evidenced significant increases ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0020748925001051

Effects of advance care planning for patients with ...

The results of the meta-analysis implied that advance care planning significantly improved the completion of advance directives (OR = 7.93, 95 % CI: 2.76–22.77, ...

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/12/7/e060201

What is the evidence for efficacy of advance care planning ...

This review provides the most comprehensive evidence to date regarding the efficacy of ACP on key patient outcomes and healthcare use/costs.

4.

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 ...

5.

withpower.com

withpower.com/trial/phase-malignancies-11-2024-0c3c2

Group Advance Care Planning for Cancer

This suggests that group ACP education could be beneficial for cancer patients by improving communication and decision-making about future health care. Show ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1462388925001085

Factors influencing advance care planning among cancer ...

Cancer patients' advance care planning is influenced by positive factors like optimistic health views and supportive family dynamics, as well as obstacles.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04660422

Study Details | NCT04660422 | Advance Care Planning ...

This study is investigating if the use of telehealth ACP Program will improve and sustain rates of ACP from the time that the intervention is implemented ...