NCT06028152

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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

August 29, 2023

Last Update Submit

February 27, 2024

Conditions

Keywords

Advance Care PlanningAdvance DirectivesTerminal Illness

Outcome Measures

Primary Outcomes (1)

  • Experiences and perceptions of intervention

    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.

    Immediately post-intervention

Secondary Outcomes (4)

  • 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

Study Arms (1)

Game participants

EXPERIMENTAL

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.

Other: End-of-life conversation game called "Hello"

Interventions

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"

Game participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\> 18 years old)
  • Able to speak and read English
  • Be an individual diagnosed with breast, lung, 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
  • Adults (\> 18 years old)
  • Able to speak and read English and/or Spanish
  • Be the chosen caregiver for a participant with cancer

You may not qualify if:

  • Anyone \<18 years of age
  • Anyone unable to speak and read English
  • Unable to provide informed consent
  • Receives cancer care exclusively outside of Penn State Health
  • Anyone \<18 years of age
  • Anyone unable to speak and read English
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Kimbel K, Hayes M, Bucher M, Calo WA, Garg T, Joshi M, Kuntz H, Murphy TE, VanDyke E, Wasserman E, Van Scoy LJ. Facilitating Advance Care Planning Conversations Among Patients With Cancer and Their Care Partners Utilizing a Conversation Game: A Pilot Study. Cancer Rep (Hoboken). 2025 Jun;8(6):e70250. doi: 10.1002/cnr2.70250.

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsUrogenital Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Lauren Van Scoy, MD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Humanities and Public Health Sciences

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 8, 2023

Study Start

October 31, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations