Messaging and advance directive distribution. All arms receive physician advance care planning education at the clinic level.

Messaging and advance directive distribution plus introduction to the Prepare For Your Care website. All arms receive physician advance care planning education at the clinic level.

Messaging and advance directive distribution, introduction to the Prepare For Your Care website, plus patient engagement from a trained facilitator who also can interact with the primary care physician. All arms receive physician advance care planning education at the clinic level.

Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.

Advance directive

Patient invited to use the Prepare For Your Care website (www.prepareforyourcare.org) that will introduce and facilitate advance care planning and guide completion of an advance directive.

Prepare

Facilitator engages patient to activate advance care planning and to carry out navigation and facilitation aspects of advance care planning. Facilitator can tee up advance care planning activities with the primary care physician.

Facilitator

Neil S Wenger, MD

Using a cluster randomized design at the clinic level, this project will implement and test three real-world, scalable advance care planning interventions among primary care clinics across three University of California health systems. Seriously ill patients identified using data from the electronic health record will receive (1) an advance directive with targeted messaging, (2) intervention 1 plus prompting to engage with the Prepare For Your Care website, or (3) intervention 2 plus engagement from a clinic-based facilitator. A Research cohort of patients will provide complete surveys at baseline, 12 and 24 months. The main outcomes are advance directive completion among the population cohort and goal concordant care among the Research cohort at 12 months.

The goal of the project is to test, implement, and disseminate real-world, scalable advance care planning (ACP) interventions among busy, primary care clinics across three UC Health systems. The study aims are as follows:

Aim 1: With the input of primary care stakeholders (i.e., adults with serious illness, caregivers and clinical staff) at each site, determine the barriers, facilitators and best workflow plans to implement the three ACP interventions.

Aim 2: Implement the three ACP interventions across primary care clinics using a cluster randomized design across three UC Health systems: distribution of an advance directive (AD) (arm 1), distribution of the AD plus prompting the patient to engage with the Prepare For Your Care website (arm 2), and the AD plus engagement with the Prepare For Your Care website plus a Care coordinator intervention to engage clinicians (arm 3).

Aim 3: Compare the effectiveness of the three interventions on documentation of ACP (represented by an AD, POLST or out-of-hospital DNR form available in the medical record) on a population-based primary care cohort of seriously ill patients across three UC Health systems, and assess ACP engagement, quality of communication and goal-concordant care among a Research cohort subset of these patients.

The investigators hypothesize that there will be a dose response of additive improvement from arm 1 to arm 2 to arm 3 on AD completion (primary outcome) at the population level and receipt of goal-concordant treatment at the Research cohort level.

Seriously ill patients commonly receive treatments at the end of life that are inconsistent with or not guided by their values and goals. People with serious illness bear a considerable burden of suffering, and complexity of illness is strongly associated with increased hospitalization and healthcare utilization. Families of patients with serious illness who die often sustain substantial financial and emotional injury. Yet, this is not an irremediable result of advanced technology and an enlarging older population: ACP - the process of discussion of end of life care, clarification of values and goals, and embodiment of preferences through written documents and medical orders - is associated with less aggressive medical care near death and earlier hospice referral, which is then associated with better quality of life for patients and better bereavement adjustment for loved ones.

Experimental evidence supports the premise that ACP improves the treatment choices made by and for people with serious illness. A systematic review concluded that ACP interventions increase completion of ADs, increase the frequency of discussions about care preferences and increase concordance between patient's preferences and end-of-life care received. An earlier review found that multicomponent interventions were more likely to result in AD completion, yet much of this work focused on hospitalized patients and patients with cancer. A systematic review of the effects of 113 ACP interventions found decreased use of life-sustaining treatment and increased hospice and palliative care, but concluded that more experimental designs and community studies are needed. Many of these reviews noted a lack of head-to-head comparison of ACP interventions and a need for structures to implement ACP in standard care. The Institute of Medicine IOM critiqued studied ACP interventions for being targeted as one-time decisions rather than being conceptualized as incorporated into the routine of care.

A fundamental gap exists in whether and how ACP interventions can be implemented at a healthcare system level. Although ACP has shown the potential to help patients and clinicians achieve the "triple aim" of improving quality of care and patient satisfaction, improving population health and lowering costs by honoring patients' wishes, it has been slow to be prioritized in healthcare systems. Even among seriously ill patients, ACP remains uncommon. Although quality and efficiency are increasingly emphasized and several health systems are in early phases of adopting programs to improve ACP, few programs have successfully implemented ACP across their healthcare system. Implementing a system-wide program among a diverse patient population with primary care physicians (PCPs) who are already overburdened with the complex management of seriously ill patients remains a challenge.

This project will implement three system-wide advance care planning interventions and compare their effect. This quality improvement project will be implemented at the level of the health system with no direct patient contact and collection of only deidentified data for evaluation of the effect of the interventions. A second project nested in the population-based quality improvement project will enroll and evaluate a Research cohort that will provide patient and caregiver level information about the effect of the three ACP interventions. These components will be conducted in an identical fashion at UCLA, UCSF and UCI.

Using a computer algorithm developed and validated for this project, data from the electronic health record will be used to delineate a group of seriously ill patients cared for in primary care that require ACP and also identify whether these patients have ADs in the electronic health record in the past 3 years. All patients receiving primary care in the health system are eligible to be identified as seriously ill patients.

The project will implement 3 real-world ACP intervention comparators using a clustered randomized trial design. The interventions are: (arm 1) distribution of an AD with a tailored message via MyChart in the electronic health record and/or postal mail, (arm 2) arm 1 plus access to the Prepare For Your Care website that is a publicly available decision support tool for ACP, and (arm 3) arm 2 plus patient engagement by a clinic-based facilitator who will tee up AD completion, Prepare website use and coordinate patient ACP interactions with primary care physicians. The interventions will continue over a 24-month period, with an evaluation at 12 and 24 months.

Comparison of the 3 intervention arms will occur at the population level by collecting deidentified data from the electronic health record reflecting AD completion (existence of an AD or POLST or outpatient DNR order and the date of the document), vital status, and healthcare utilization (hospitalization, ICU use, ED use, and location of death).

A Research cohort will be enrolled from the seriously ill population-based cohort that do not have an AD or POLST within the past three years by asking patients via mail, telephone, or in person whether they are willing to participate in an observational survey study. Interested patients will be asked to provide written informed consent to participate in up to 3 surveys: baseline, 12 months and 24 months. The surveys may be completed on a paper-and-pencil hard copy, completed by interview over the telephone, completed in person or completed over a secure web link, depending on patient preference. The surveys will ask about experience with and readiness for ACP, health status, preferences for healthcare and decision making, and demographics. If a patient is unable to be surveyed at month 12 or month 24, a caregiver will be approached for survey. If the patient dies, a caregiver will be asked to complete a survey about goal-concordant treatment, perceptions about care and satisfaction with care and communication. Patients will also be asked to consent to medical record review to evaluate documentation about ACP and measure goal concordant care. The principle outcome is AD completion at the population level using administrative data from the electronic health record.

Cluster randomized trial at the primary care clinic level

UC Health Care Planning Study

Population-based Comparison of Evidence-based, Patient-centered Advance Care Planning Interventions on Advance Directive Completion, Goal Concordant Care and Caregiver Outcomes for Patients With Advanced Illness

Hospitalization, ICU care and ER visits within 30 days of death will be compared among decedents of the three study arms using regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

Advance care planning level of engagement and conversations based on survey (Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465).

Advance care planning level of engagement and conversations based on validated survey (Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465).

Proportion of patients that have advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) at 12 months (or death) compared to baseline. Baseline date defined as the clinic intervention start date. Intention to treat analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

Goal concordant care measured by patient/caregiver reports of receipt of preference concordant care based on questions from SUPPORT (Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival. J Am Geriatr Soc. 2002;50(3):496-500. doi:10.1046/j.1532-5415.2002.50116.)

Advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) among patients with no advance care planning documentation in the past three years. Baseline date defined as receipt of intervention. "As treated" analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

Caregiver report of quality of end of life care among decedents based on the modified Bereaved Family Survey

Proportion of patients that have advance care planning documentation

Goal concordant care measured as match of care receipt to future care preference based on survey

Goal concordant care measured as caregiver post-mortem report goal concordant care (Teno JM, Freedman VA, Kasper JD, Gozalo P, Mor V. Is care for the dying improving in the United States? J Palliat Med. 2015;18(8):662-6).

University of California, San Francisco

University of California, Irvine

University of California, Los Angeles

Professor

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Death

Breast Neoplasms

Lung Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

All participants will engage in playing the end-of-life conversation game called "Hello", which involves answering open-ended questions about medical decision making and end-of-life issues.

To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').

Other Name: Previously named "My Gift of Grace"

End-of-life conversation game called "Hello"

Lauren Van Scoy, MD

The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with breast, lung, and/or genito-urinary cancers treated at Penn State Cancer Institute and their loved ones perform advance care planning. The main questions it aims to answer are:

* What modifications and/or adaptations are necessary to Hello for use in cancer populations?
* How do different delivery models compare for recruitment in terms of feasibility and efficiency?

Participants will:

* Complete pre-game questionnaires
* Play the Hello game
* Complete post-game questionnaires
* Participate in a focus group

Previous studies conducted by the investigators have shown that the Hello game demonstrates successful ACP engagement in general populations, but has yet to be tailored to meet the unique needs of patients with advanced cancer and their caregivers. Outlining their care preferences by engaging in ACP is an important aspect of care according to patients with advanced cancer. However, only 55% of patients with advanced cancer patients have participated in ACP. These patients have substantial bio-psycho-social stressors that distinguish their ACP needs from others. Tailoring established interventions that foster high quality conversations about medical treatment preferences and end-of-life issues (such as the Hello game) is critically important for this population given its unique needs. As evidenced by qualitative interviews with \>200 participants, the Hello game creates a safe environment for sensitive conversations about end-of-life issues and inspired sharing of rich perspectives, with no reported adverse events, excessive burden, or negative emotional effects. That said, the intervention must be adapted for patients with cancer, particularly those with advanced cancer and their caregivers.

Additionally, while several effective ACP interventions exist (including Hello), how best to disseminate these interventions has not been rigorously or systematically studied. In other ongoing and previous studies, the investigators have demonstrated success in both engaging individuals living in underrepresented communities in ACP and successfully enrolling them in interventional research about ACP. The investigators credit these successes to their unique intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to discuss end-of-life issues) by leveraging established community connections to recruit participants to participate in ACP interventions as well as research. In the CBDM, trusted community "hosts" (who are leaders from local hospice organizations, senior centers, health agencies) invite participants to attend an ACP event. They introduce the research team to the attendees who may choose to participate in the ACP activity, the research, or both. Hosts are provided with marketing materials and utilize their community network channels to advertise the event. This model allows for research to be conducted more easily within hard to reach and underserved communities such as Black, Hispanic and rural communities- much like the most remote communities across the PSCI's 28-county catchment area.

Patients with cancer, however, are unique, and may require an alternative approach that involves partnering with their oncology care team to introduce the concept of ACP and encourage participation in ACP and research. Notably, there is evidence that patients are more likely to engage in ACP when recommended by their physician, so how best to approach ACP for cancer patients is unknown. A common approach to ACP intervention research is to use a Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is recommended by the patient's clinician (rather than through community-based outreach groups). For this intervention delivery approach, research assistants support interactions between clinicians (providers or nurses) to find appropriate patients and garner interest in performing ACP. This model is commonly used to recruit patients for clinical trials, including ACP interventions. For patients with cancer, the HBDM may have some advantages over the CBDM, given the close bonds that form between a patient and clinical care team as they interact frequently during active treatments such as infusions and radiation that often span several hours and weeks. Leveraging these therapeutic relationships may support greater acceptance of opportunities to broach ACP than a community-based model, but this remains unknown.

Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning

Adapting an Advance Care Planning Intervention and Delivery Model for Use With Patients With Cancer and Their Caregivers

Group discussions held with patients with cancer and their caregivers to collect qualitative data on acceptability of the game, necessary modifications for use in patients with cancer and their caregivers, and other feedback and opinions on the game experience.

This 4-item short-version survey measures readiness to perform ACP.

This 17-item survey measures surrogate decision maker readiness to perform ACP.

This 8-item survey measures participants' satisfaction with the conversation. Each item is scored on a 1-7 scale with 1 being lowest conversation satisfaction. The items are averaged for the final score ranging 1-7 with 7 indicating the highest conversation satisfaction.

This 3-item survey measures participants' perceived acceptability of the intervention.

Milton S. Hershey Medical Center

Professor of Medicine, Humanities and Public Health Sciences

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma

Melanoma

Skin Neoplasms

Carcinoma, Squamous Cell

Lymphoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Neoplasms, Basal Cell

Lymphosarcoma

patients with a skin lymphoma OR melanoma OR advanced skin squamous cell carcinoma OR advanced basal cell carcinoma accepting to answer to the anonymous survey

we will ask patients to answer to a survey

no intervention, only complete a survey

Anne-Claire BURSZTEJN

anne-claire Bursztejn

anne-claire bursztejn

The law about advance directives is evolving but, in France, few people write it.

Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.

Seconds endpoints are :

For patients against or not planning to write it, understand their reasons

Estimate the proportion of patients requesting information and understand how they would like to receive it.

Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.

ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS

Writing by the patient of his advance directves and, if not writing, positioning of the patient (rather favorable or rather unfavorable) as to the writing of his advance directives.

In patients who have not written their advance directives: reason for not writing the advance directives.

Central Hospital, Nancy, France

Behaviors and Mental Disorders

Anxiety Disorders

Depression

Depressive Disorder

Quality of Life

Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) is a mindfulness meditation-based intervention to facilitate timely advance care planning (ACP) and end-of-life conversations with greater ease. Participants are taught a variety of mindfulness practices (e.g., breath awareness, sitting meditation, mindful movement through gentle yoga, and mindful communication) that can be used to enhance end-of-life coping.

The Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) intervention is two-pronged and mutually interactive with: (1) a patient and family caregiver group, and (2) an oncology provider group. Patients and family caregivers meet as a group for 6 weekly sessions of 2 hours each, for a total of 12 hours of class time. Oncology providers will have 5 class sessions for a total of 16 hours of class time. One class is held conjointly with patients, family caregivers, and providers to practice newly-learned skills. The course curriculum is generally based on mindfulness practices, group discussion, and didactic teaching with an emphasis on embodying interpersonal mindfulness in dialogue in daily life.

MODEL Care

Shelley A. Johns, PsyD

The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care.

Mindfully Optimizing Delivery of End-of-Life Care

Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care): Feasibility of a Synergistic Intervention for Patients, Family Caregivers, and Providers

The number of individuals who are eligible will be divided by the number of individuals approached.

The number of enrolled individuals will be divided by the number of eligible individuals.

The mean number of sessions attended by each participant type (i.e., patients, family caregivers, providers) will be calculated and compared to the total number of MODEL care sessions provided (i.e., 6 for patients/family caregivers and 5 for providers).

The proportion of the total number of participants enrolled who completed post-intervention assessments (at 6 weeks) will be calculated by dividing the number of individuals assessed post-intervention (6 weeks) by the number of participants who were enrolled/assessed at baseline.

An investigator-created measure of intervention satisfaction will be administered. This measure includes items assessing participants' overall satisfaction, satisfaction with different components of the intervention, likelihood of recommending the course to others, and the intention to continue using MODEL Care skills. The mean score on the satisfaction scale will be calculated for each group (patients, family caregivers, and providers) post-intervention (6 weeks).

The proportion of the total number of participants enrolled who completed 1-month follow-up assessments (at 10 weeks) will be calculated by dividing the number of individuals who were assessed at 1-month follow-up (10 weeks) by the number of participants enrolled/assessed at baseline.

To measure avoidant coping, the Brief COPE and Mini-Mental Adjustment to Cancer (Mini-MAC) scales will be administered to patients and family caregivers. To assess avoidance among participating health care providers, items adapted from a study assessing effects of end-of-life communication training, and 4 subscales from the Young-Rygh Avoidance Inventory will be used. The effects of MODEL Care on avoidant coping will be determined by calculating the change in avoidant coping scores from baseline to post-intervention (6 weeks) for each group of participants on their respective measures.

To measure avoidant coping, the Brief COPE and Mini-Mental Adjustment to Cancer (Mini-MAC) scales will be administered to patients and family caregivers. To assess avoidance among participating health care providers, items adapted from a study assessing effects of end-of-life communication training and 4 subscales from the Young-Rygh Avoidance Inventory will be used. The effects of MODEL Care on avoidant coping will be determined by calculating the change in avoidant coping scores from baseline to 1-month follow-up for each group of participants on their respective measures.

Patients' quality of life will be measured with the McGill Quality of Life Inventory. Family caregivers' quality of life will be assessed with Caregiver Quality of Life Index-Cancer. Health care providers' quality of life will be assessed using the Professional Quality of Life measure, and Satisfaction with Life scale. The effects of MODEL Care on quality of life will be determined by calculating the change in quality of life scores from baseline to post-intervention (6 weeks) for each group of participants.

Patients' quality of life will be measured with the McGill Quality of Life Inventory. Family caregivers' quality of life will be assessed with the Caregiver Quality of Life Index-Cancer. Health care providers' quality of life will be assessed using the Professional Quality of Life measure, and Satisfaction with Life scale. The effects of MODEL Care on quality of life will be determined by calculating the change in quality of life scores from baseline to 1-month follow up for each group of participants.

Depression will be assessed for all 3 groups using the 8-item Patient Health Questionnaire depression scale (PHQ-8). The effects of MODEL Care on depression will be determined by calculating the change in PHQ-8 scores from baseline to post-intervention ( 6 weeks) for each group of participants.

Depression will be assessed for all 3 groups using the 8-item Patient Health Questionnaire depression scale (PHQ-8). The effects of MODEL Care on depression will be determined by calculating the change in PHQ-8 scores from baseline to 1-month follow up for each group of participants.

Anxiety will be assessed for all 3 groups using the Generalized Anxiety Disorder scale (GAD-7). The effects of MODEL Care on anxiety will be determined by calculating the change in GAD-7 scores from baseline to post-intervention (6 weeks) for each group of participants.

Anxiety will be assessed for all 3 groups using the Generalized Anxiety Disorder scale (GAD-7). The effects of MODEL Care on anxiety will be determined by calculating the change in GAD-7 scores from baseline to 1-month follow up for each group of participants.

Patients' readiness to complete 3 advance care planning behaviors (i.e., Physician's Orders for Scope of Treatment form, discussing "goals of care" with their oncologist, and discussing "goals of care" with their family) will be assessed. Responses to these 3 items will indicate the patient's stage of readiness (ranging from pre-contemplation to maintenance) on each behavior. The effects of MODEL Care on advance care planning will be determined by calculating the change in readiness stage category on each behavior from baseline to post-intervention (6 weeks) for patients.

Patients' readiness to complete 3 advance care planning behaviors (i.e., Physician's Orders for Scope of Treatment form, discussing "goals of care" with their oncologist, and discussing "goals of care" with their family) will be assessed. Responses to these 3 items will indicate the patient's stage of readiness (ranging from pre-contemplation to maintenance) on each behavior. The effects of MODEL Care on advance care planning will be determined by calculating the change in readiness stage category on each behavior from baseline to 1-month follow-up for patients.

Walther Cancer Institute

Charles Warren Fairbanks Center for Medical Ethics

Indiana University

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Head and Neck Neoplasms

Liver Neoplasms

Pancreatic Cancer

Stomach Cancer

For this arm, individuals will play the modified Hello game (Hello for Cancer). This game was modified to be better suited for individuals with cancer and their loved ones, and those modifications are now being tested. This game will include questions related to a variety of topics around an individual's cancer experience and medical decision making related to their cancer diagnosis.

After playing the game, individuals will be asked to reflect on the game questions and provide feedback to inform further modifications.

For this arm, individuals will play commercially available Table Topics game during the research event. This game asks a variety of conversation starting questions, not particularly related to medical decision making.

To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').

The questions used in Hello for Cancer were modified from the original Hello game based on the results of phase 1 of testing this game in cancer populations. The modifications made to the game will be assessed for acceptability during this study.

Hello for Cancer game

To play Table Topics, players are provided a deck of cards that have a variety of general conversation starter questions. The group takes turns selecting a card and reading it to the group for the group to answer. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').

Table Topics game

Kylee Kimbel, BS

Michael Hayes, PhD

Monika Joshi

The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are:

What modifications and/or adaptations are necessary to Hello for use in cancer populations?

What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics?

Participants will:

* Complete pre-game questionnaires
* Play either Hello or Table Topics game
* Complete post-game questionnaires
* Participate in a focus group
* Complete a telephone follow up interview 1-4 months after their event

This study is a continuation of NCT06028152.

Previous studies conducted by the investigators have shown that the Hello game demonstrates successful advance care planning (ACP) engagement in general populations, but has yet to be tailored to meet the unique needs of patients with advanced cancer and their caregivers. Outlining their care preferences by engaging in ACP is an important aspect of care according to patients with advanced cancer. However, only 55% of patients with advanced cancer patients have participated in ACP. These patients have substantial bio-psycho-social stressors that distinguish their ACP needs from others. Tailoring established interventions that foster high quality conversations about medical treatment preferences and end-of-life issues (such as the Hello game) is critically important for this population given its unique needs. As evidenced by qualitative interviews with \>200 participants, the Hello game creates a safe environment for sensitive conversations about end-of-life issues and inspired sharing of rich perspectives, with no reported adverse events, excessive burden, or negative emotional effects. That said, the intervention must be adapted for patients with cancer, particularly those with advanced cancer and their caregivers.

Additionally, while several effective ACP interventions exist (including Hello), how best to disseminate these interventions has not been rigorously or systematically studied. In other ongoing and previous studies, the investigators have demonstrated success in both engaging individuals living in underrepresented communities in ACP and successfully enrolling them in interventional research about ACP. The investigators credit these successes to their unique intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to discuss end-of-life issues) by leveraging established community connections to recruit participants to participate in ACP interventions as well as research. In the CBDM, trusted community "hosts" (who are leaders from local hospice organizations, senior centers, health agencies) invite participants to attend an ACP event. They introduce the research team to the attendees who may choose to participate in the ACP activity, the research, or both. Hosts are provided with marketing materials and utilize their community network channels to advertise the event. This model allows for research to be conducted more easily within hard to reach and underserved communities such as Black, Hispanic and rural communities- much like the most remote communities across the Penn State Cancer Institute's 28-county catchment area.

Patients with cancer, however, are unique, and may require an alternative approach that involves partnering with their oncology care team to introduce the concept of ACP and encourage participation in ACP and research. Notably, there is evidence that patients are more likely to engage in ACP when recommended by their physician, so how best to approach ACP for cancer patients is unknown. A common approach to ACP intervention research is to use a Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is recommended by the patient's clinician (rather than through community-based outreach groups). For this intervention delivery approach, research assistants support interactions between clinicians (providers or nurses) to find appropriate patients and garner interest in performing ACP. This model is commonly used to recruit patients for clinical trials, including ACP interventions. For patients with cancer, the HBDM may have some advantages over the CBDM, given the close bonds that form between a patient and clinical care team as they interact frequently during active treatments such as infusions and radiation that often span several hours and weeks. Leveraging these therapeutic relationships may support greater acceptance of opportunities to broach ACP than a community-based model, but this remains unknown.

Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2

Adapting an Advance Care Planning Intervention for Use With Patients With Cancer and Their Care Partners: Phase Two

Focus groups will be conducted with individuals randomized to play the Hello for Cancer game. These focus groups will focus on learning about the participants' perception of playing the modified game and identified any questions that need additional modification.

The patient's medical chart will be reviewed to collect data on their medical history as related to their cancer diagnosis. The medical chart will be reviewed for up to two years after participation to capture hospitalizations, intensive care unit admissions, and emergency department visits that occur after the individual's participation in the study.

Additionally, the patient's chart will be reviewed to identify if since the event any advance directives were uploaded to the medical chart and if there is documentation about conversations regarding medical decision making and ACP with the health care team.

During the follow up interview, presence of ACP behaviors since participation in research event will be assessed. Specifically, individuals will be asked if they have completed any advance directives or had conversations with loved ones or family members about advance care planning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
UC Health Care Planning Study	NCT04012749	Advance Care Pl... Advance Directi... Advanced Cancer	Advance directi... Prepare Facilitator	18 Years -	University of California, Los Angeles
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning	NCT06028152	Breast Cancer Lung Cancer Genito Urinary ...	End-of-life con...	18 Years -	Milton S. Hershey Medical Center
ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS	NCT03822988	Advance Directi... Oncology Skin Cancer Melanoma Skin Lymphoma Skin Squamous C... Metastatic Basa...	no intervention...	18 Years -	Central Hospital, Nancy, France
Mindfully Optimizing Delivery of End-of-Life Care	NCT02367508	Cancer Coping Skills	MODEL Care	18 Years -	Indiana University
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2	NCT06384417	Breast Cancer Lung Cancer Genito-Urinary ... Colorectal Canc... Gastric Cancer Pancreatic Canc... Liver Cancer Head and Neck C... Melanoma	Hello for Cance... Table Topics ga...	18 Years -	Milton S. Hershey Medical Center
UC Health Care Planning Study	NCT04012749	Advance Care Pl... Advance Directi... Advanced Cancer	Advance directi... Prepare Facilitator	18 Years -	University of California, Los Angeles
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2	NCT06384417	Breast Cancer Lung Cancer Genito-Urinary ... Colorectal Canc... Gastric Cancer Pancreatic Canc... Liver Cancer Head and Neck C... Melanoma	Hello for Cance... Table Topics ga...	18 Years -	Milton S. Hershey Medical Center
Mindfully Optimizing Delivery of End-of-Life Care	NCT02367508	Cancer Coping Skills	MODEL Care	18 Years -	Indiana University

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