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Breast CancerNCT06028152

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

A study testing End-of-life conversation game called "Hello" in people with Breast Cancer and Lung Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Lung Cancer, Genito Urinary Cancer
What is being tested?
End-of-life conversation game called "Hello"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
31 Oct 2023to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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

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
Read the detailed description

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.

Being tested
End-of-life conversation game called "Hello"
Keywords
Advance Care Planning, Advance Directives, Terminal Illness
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Urogenital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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"

Study groups in NCT06028152
Study groupRoleWhat they receive
Game participantsExperimentalAll 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.
Receives: Other: End-of-life conversation game called "Hello"

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately post-intervention

Secondary outcomes (4)
  1. Advance Care Planning Engagement Measure

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

    Measured: Baseline

  2. Advance Care Planning Surrogate Decision Maker Engagement Measure

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

    Measured: Baseline

  3. Satisfaction of Intervention Measure

    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.

    Measured: Immediately post-intervention

  4. Acceptability of Intervention Measure

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

    Measured: Immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start31 Oct 2023
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028152
Sponsor's protocol ID
STUDY00023029
Status last verified
Feb 2024
First submitted
29 Aug 2023
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40528532

Questions about this trial

What is this clinical trial studying?

A study testing End-of-life conversation game called "Hello" in people with Breast Cancer and Lung Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Experiences and perceptions of intervention (time frame: Immediately post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028152, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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