Clinical trial NCT06384417: Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2
Official title: Adapting an Advance Care Planning Intervention for Use With Patients With Cancer and Their Care Partners: Phase Two
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Genito-Urinary Cancer
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Liver Cancer
Head and Neck Cancer
Melanoma
Keywords: Advance Care Planning
Advance Directives
Cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria Patient with Cancer:

* Adults (\> 18 years old)
* Able to speak and read English and/or Spanish
* Be an individual diagnosed with a solid tumor cancer (e.g., breast, colon, lung, melanoma, head and neck, or genitourinary/prostate cancer) as verified by primary oncologist or is the chosen caregiver for a participant with those cancers
* Receives care at Penn State Health or is the chosen caregiver for a participant treated at Penn State Health

Exclusion Criteria Patient with Cancer:

* Has completed an advance directive since cancer diagnosis as verified by presence in the patient's medical chart
* Has not received treatment for their cancer at a Penn State Health facility in the past year
* Unable to consent to participate in study

Inclusion Criteria Caregiver/Loved one:

* Adults (\> 18 years old)
* Able to speak and read English and/or Spanish
* Be the chosen caregiver for a participant with cancer

Exclusion Criteria Caregiver/Loved one:

\* Unable to consent to participate in study

Primary outcomes:
measure: Perceptions of modified intervention
timeFrame: immediately post-intervention
measure: Healthcare Utilization
timeFrame: Baseline to up to two years after participation in research event
Secondary outcomes:
measure: Advance Care Planning Engagement Measure
timeFrame: Baseline
measure: Advance Care Planning Surrogate Decision Maker Engagement Measure
timeFrame: Baseline
measure: Satisfaction of Intervention Measure
timeFrame: Immediately post-intervention
measure: Acceptability of Intervention Measure
timeFrame: Immediately post-intervention
measure: Preliminary efficacy of Hello on ACP behaviors.
timeFrame: Event follow-up interview (one to four months post event)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Lauren Van Scoy, MD
role: PRINCIPAL_INVESTIGATOR
References: