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

NCT06384417 | Active Not Recruiting

• 1 other identifier: STUDY00024858
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Perceptions of modified intervention

  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.

  immediately post-intervention

• Healthcare Utilization

  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.

  Baseline to up to two years after participation in research event

Secondary Outcomes (5)

• Advance Care Planning Engagement Measure

  Baseline

• Advance Care Planning Surrogate Decision Maker Engagement Measure

  Baseline

• Satisfaction of Intervention Measure

  Immediately post-intervention

• Acceptability of Intervention Measure

  Immediately post-intervention

• Preliminary efficacy of Hello on ACP behaviors.

  Event follow-up interview (one to four months post event)

Study Arms (2)

Hello for Cancer game

EXPERIMENTAL

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.

Behavioral: Hello for Cancer game

Table Topics game

PLACEBO COMPARATOR

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.

Other: Table Topics game

Interventions

Hello for Cancer game BEHAVIORAL

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

Table Topics game OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Urogenital Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Head and Neck Neoplasms; Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Lauren Van Scoy, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Humanities and Public Health Sciences

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)