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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with advanced lung or gastrointestinal cancer by facilitating meaningful conversations about their care goals, known as "Goals of Care Discussion." The goal is to enhance patients' quality of life and support their families while potentially reducing care costs. Participants will receive either the usual care at an Acute Cancer Care Center or the usual care with additional support for discussing their care goals. This trial suits those with advanced cancer without curative options, who experience issues like trouble breathing or confusion, and can communicate in English. As an unphased trial, it provides a unique opportunity to improve quality of life through personalized care discussions.

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 prior data suggests that this protocol is safe for participants with advanced cancer?

Research shows that discussing care goals is safe for patients. These conversations differ from taking medicine or undergoing surgery; they focus on the type of care patients desire as their illness progresses. This ensures that the medical care they receive aligns with their wishes.

Studies indicate that patients who engage in these discussions with their doctors often have better experiences. For example, they tend to be hospitalized less frequently. In one study, only 5% of patients who participated in these conversations were readmitted to the hospital. This suggests that such talks can help manage care more effectively without causing harm.

Overall, discussing care goals is well-received and aims to improve quality of life. Unlike medical treatments like drugs or surgeries, these conversations do not carry risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Goals of Care Discussion intervention because it focuses on enhancing communication between patients with advanced lung and gastrointestinal cancer and their healthcare providers. Unlike typical treatments that primarily target physical symptoms with medications or procedures, this approach aims to align medical care with the patients' personal values and preferences. By integrating these discussions into the standard emergency room care, the intervention has the potential to improve patient satisfaction and quality of life, offering a more holistic approach to cancer care.

What evidence suggests that the Goals of Care Discussion is effective for improving quality of life in advanced cancer patients?

Research has shown that discussing care goals can significantly benefit patients with advanced cancer. In this trial, participants in the "Goals of Care" arm will receive a goals of care (GOC) intervention alongside the usual standard of care. One study found that nearly half of the patients with Stage IV cancer had documented conversations about their care goals, leading to better use of palliative care. These discussions often aim to enhance quality of life and support the needs of patients and their families. Another study found that both patients and doctors value quality of life and life extension during these discussions. Overall, discussing care goals helps tailor treatment to what matters most to patients, potentially improving their well-being and satisfaction. ^{1 3 5 6 7}

Who Is on the Research Team?

Ahmed Elsayem, MD,MPH

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 comatose

Participant has severe intellectual disability

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06420206

Goals of Care Discussion for Patients With Advanced Lung ... To obtain data on rates of admission to the ICU, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5749575/

Integrating Palliative and Oncology Care for Patients with ... By the end of the study period, 33% of Stage IV cancer inpatients accessed specialty palliative care and 48% had a documented GOC discussion. Screening for ...

3. careacross.com careacross.com/clinical-trials/trial/NCT06420206

Goals of Care Discussion for Patients With Advanced Lung ... Summary: To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care. Detailed description: Primary ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1525730420302084

What Goals Do Patients and Oncologists Have When ... Patients and oncologists reported quality of life (respectively, 45% and 72%), life prolongation (45% and 55%), decrease in tumor size (39% and 66%), and cure ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6108347/

Goals-of-care discussions - PMC Patients who had consultations that included GoC discussions in addition to a symptom management consultation had a lower hospital readmission rate of 5%, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02374255

Improving Goals of Care Discussion in Advanced Cancer ... The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these ...