Goals of Care Discussions for Advanced Lung and Gastrointestinal Cancer

Overseen By Ahmed Elsayem, MD,MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hospice, Comatose, Dementia, others

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

Compensation: Varies

Number of Visits: 1

200 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Goals of Care Discussion for advanced lung and gastrointestinal cancer?

Research shows that having goals of care conversations can improve outcomes for seriously ill patients, such as better pain and symptom management and higher patient satisfaction. ^{1 2 3 4 5}

Is it safe to participate in Goals of Care Discussions for cancer treatment?

Goals of Care Discussions are generally considered safe as they involve conversations about treatment preferences and care planning, rather than medical procedures or medications that might have side effects. ^{6 7 8 9 10}

How does the Goals of Care Discussions treatment differ from other treatments for advanced lung and gastrointestinal cancer?

The Goals of Care Discussions treatment is unique because it focuses on early conversations between patients and oncologists about care preferences and treatment goals, rather than a specific medical intervention. This approach aims to improve patient-centered decision-making and ensure that care aligns with the patient's values and wishes, which is different from traditional treatments that primarily focus on medical or surgical interventions. ^{5 7 10 11 12}

What is the purpose of this trial?

To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.

Research Team

Ahmed Elsayem, MD,MPH

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with advanced lung or gastrointestinal cancer who visit the emergency department of a comprehensive cancer center. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.

Inclusion Criteria

My lung or GI cancer is advanced and cannot be cured with treatment.

Participant has the ability to speak and write in English

I experience shortness of breath, confusion, or am unable to perform daily activities.

Exclusion Criteria

Participant is already enrolled in hospice

Participant is new to MDACC, without established oncology care at our institution at time of ACCC arrival

Participant is comatose

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Emergency Department Visit

Participants receive standard care or goals of care intervention during their emergency department visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as ICU admission, hospital death, symptom improvement, hospice referral, and survival over a 30-day period

30 days

Treatment Details

Interventions

• Goals of Care Discussion

Trial Overview The study aims to compare two standard care approaches in the emergency setting: one focused on acute cancer care and another that includes discussions about goals of care, assessing their impact on quality of life and cost.

Participant Groups

Group I: Goals of Care Experimental Treatment 1 Intervention

In Group 2, participants will receive the above usual standard of care plus goals of care (GOC) intervention.

Group II: Acute Cancer Care Center Experimental Treatment 1 Intervention

In Group 1, participants will receive the usual standard of care, during your emergency room visit, provided by the Acute Cancer Care Center (ACCC) treating doctor who will address symptoms and other medical problems that brought the participant to the emergency room.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Patients with advanced cancer prioritize treatment goals, such as curing and fighting cancer, over life goals, indicating a strong focus on their medical outcomes.

Those who highly value a cure tend to have worse performance status and more depressive symptoms, suggesting that this strong focus may lead to psychological challenges as they cope with their illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life and treatment goals of patients with advanced, incurable cancer. Rand, KL., Banno, DA., Shea, AM., et al.[2018]

In a study involving 206 patients with advanced cancer and their oncologists, only 23.3% of patient-oncologist pairs had strong agreement on goals of care related to survival or comfort, indicating a significant gap in understanding patients' end-of-life preferences.

There was a notable association between the level of agreement on goals of care and the use of aggressive treatments at the end of life, suggesting that better communication about these goals could potentially reduce unnecessary aggressive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between strong patient-oncologist agreement regarding goals of care and aggressive care at end-of-life for patients with advanced cancer. Douglas, SL., Daly, BJ., Lipson, AR., et al.[2023]

Implementing a Goals of Care (GOC) note template in a cancer center improved documentation of end-of-life (EOL) discussions, leading to significant changes in patient care, such as fewer inpatient days and increased hospice referrals.

Patients with GOC notes that included EOL discussions documented more than 30 days before death experienced shorter hospital stays and less aggressive treatment, indicating that early GOC documentation is linked to better quality of EOL care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goals of care documentation by medical oncologists and oncology patient end-of-life care outcomes. Epstein, AS., Riley, M., Nelson, JE., et al.[2023]

A systematic effort at Duke Health led to a 50% increase in documented Goals of Care (GOC) conversations among patients in their last 6 months of life, which can enhance pain management and patient satisfaction.

The combination of the RE-AIM model and design thinking strategies proved effective in promoting behavior change within the health system, highlighting the importance of structured approaches in improving patient care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Design Thinking to Promote Goals of Care Conversations With Seriously Ill Patients. Casarett, D., Lakis, K., Ma, JE., et al.[2023]

Involving both patients and physicians in the design of a trial aimed at improving oncologists' communication skills led to the development of a valuable intervention for facilitating goals-of-care discussions with patients with advanced cancer.

The collaborative approach ensured that the intervention was aligned with the needs of physicians and the preferences of patients, potentially enhancing the effectiveness of communication during critical disease management conversations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speaking Up: How Patient and Physician Voices Shaped a Trial to Improve Goals-of-Care Discussions. Solomon, R., Smith, C., Kallio, J., et al.[2019]

In a study of 380 patients with metastatic breast cancer undergoing first-line chemotherapy, certain adverse events (AEs) like grade 1 nausea and oral mucositis significantly decreased health utility and quality of life, as measured by the EQ-5D-3L and EORTC QLQ-C30 scales.

Specific AEs, including fatigue and sensory neuropathy, were linked to lower global health status and functioning, highlighting the importance of managing these side effects to improve patient quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study. Hagiwara, Y., Shiroiwa, T., Shimozuma, K., et al.[2019]

Gynecologic oncology clinicians play a crucial role in facilitating goals of care discussions with patients, leveraging their long-term relationships to support patient-centered decision-making.

The article outlines best practices for conducting these discussions, emphasizing the importance of timing and components to ensure effective communication and care planning for patients with gynecologic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for goals of care discussions in patients with gynecologic cancer. Peters, PN., Havrilesky, LJ., Davidson, BA.[2023]

Effective communication about diagnosis, prognosis, and patient goals is crucial in oncology, yet there are significant deficiencies in how this information is shared between physicians and patients.

The systematic review identified key domains for high-quality cancer care, including the integration of palliative care, advance care planning, and continuity of care, which should be standardized in care pathways to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based recommendations for information and care planning in cancer care. Walling, A., Lorenz, KA., Dy, SM., et al.[2022]

The Serious Illness Care Program (SICP) was successfully implemented at Stanford Health Care, engaging 5,349 unique patients in serious illness conversations, which improved the quality and timing of these important discussions.

Key factors for successful implementation included innovative clinical workflows, the use of machine learning to identify eligible patients, and the involvement of nonphysician care team members, highlighting a collaborative approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from a Multi-Site, Team-Based Serious Illness Care Program Implementation at an Academic Medical Center. Seevaratnam, B., Wang, S., Fong, R., et al.[2023]

Oncologists identified several facilitators for having goals of care (GoC) conversations with patients, including the patient's poor functional status and high health literacy, as well as a supportive practice environment.

Barriers to these conversations included patient demographics, cultural factors, denial about the illness, and time constraints, highlighting the need for improved communication training and supportive practices in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and Barriers to Oncologists' Conduct of Goals of Care Conversations. Schulman-Green, D., Lin, JJ., Smith, CB., et al.[2018]

The documentation of Goals of Care (GoC) for patients with advanced pancreatic cancer significantly increased from 7.8% in 2010 to 50.0% in 2015 during a quality improvement initiative in Northern Alberta, indicating improved advanced care planning practices.

GoC designations were more frequently documented by palliative care physicians, but the involvement of medical oncologists rose over time, suggesting a growing recognition of the importance of GoC discussions in oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing Rates of Goals of Care Designations in Patients With Advanced Pancreatic Cancer During a Multifactorial Advanced Care Planning Initiative: A Real-World Evidence Study. Anaka, M., Lee, M., Lim, E., et al.[2023]

Oncologists found that initiating Goals of Care (GOC) discussions early, particularly at the diagnosis of advanced cancer, is crucial for better patient outcomes, as most discussions currently happen too late, near end of life.

The study identified key principles for effective GOC discussions and highlighted barriers to these conversations, leading to the creation of an educational model aimed at improving the culture of GOC discussions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologist Experience Implementing Goals of Care Discussions in Everyday Ambulatory Oncology Practice: Implications for Education. Robinson, CA., Fyles, G., McKenzie, M.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Life and treatment goals of patients with advanced, incurable cancer. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Association between strong patient-oncologist agreement regarding goals of care and aggressive care at end-of-life for patients with advanced cancer. [2023]

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

Goals of care documentation by medical oncologists and oncology patient end-of-life care outcomes. [2023]

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

Using Design Thinking to Promote Goals of Care Conversations With Seriously Ill Patients. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Speaking Up: How Patient and Physician Voices Shaped a Trial to Improve Goals-of-Care Discussions. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study. [2019]

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

Guidelines for goals of care discussions in patients with gynecologic cancer. [2023]

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

Evidence-based recommendations for information and care planning in cancer care. [2022]

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

Lessons Learned from a Multi-Site, Team-Based Serious Illness Care Program Implementation at an Academic Medical Center. [2023]

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

Facilitators and Barriers to Oncologists' Conduct of Goals of Care Conversations. [2018]

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

Changing Rates of Goals of Care Designations in Patients With Advanced Pancreatic Cancer During a Multifactorial Advanced Care Planning Initiative: A Real-World Evidence Study. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Oncologist Experience Implementing Goals of Care Discussions in Everyday Ambulatory Oncology Practice: Implications for Education. [2018]