Breast CancerNCT06384417
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2
A study testing Hello for Cancer game and Table Topics game in people with Breast Cancer and Lung Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
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 various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State… 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?
- Hello for Cancer game and Table Topics game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 31 Dec 2025
- 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 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
- 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
- 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
- Unable to consent to participate in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
About this study
Official title: Adapting an Advance Care Planning Intervention for Use With Patients With Cancer and Their Care Partners: Phase Two
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?
Read more
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.
Read the 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.
- Conditions
- Breast Cancer, Lung Cancer, Genito-Urinary Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Being tested
- Hello for Cancer game, Table Topics game
- Keywords
- Advance Care Planning, Advance Directives, Cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Urogenital Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hello for Cancer gameBehavioural
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.
Table Topics gameOther
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').
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Table Topics game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to up to two years after participation in research event
Secondary outcomes (5)
Advance Care Planning Engagement Measure
This 4-item short-version survey measures readiness to perform ACP.
Measured: Baseline
Advance Care Planning Surrogate Decision Maker Engagement Measure
This 17-item survey measures surrogate decision maker readiness to perform ACP.
Measured: Baseline
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
Acceptability of Intervention Measure
This 3-item survey measures participants' perceived acceptability of the intervention.
Measured: Immediately post-intervention
Preliminary efficacy of Hello on ACP behaviors.
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.
Measured: Event follow-up interview (one to four months post event)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start27 Jun 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Van Scoy, Milton S. Hershey Medical Center
- Investigators
- Lauren Van Scoy, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384417
- Sponsor's protocol ID
- STUDY00024858
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting an Advance Care Planning Intervention for Use With Patients With Cancer and Their Care Partners: Phase Two
- ClinicalTrials.gov ID
- NCT06384417
- Acronym / sponsor ID
- STUDY00024858
- Conditions
- Breast Cancer, Lung Cancer, Genito-Urinary Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Keywords
- Advance Care Planning, Advance Directives, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hello for Cancer game | Experimental | Behavioral: Hello for Cancer gameFor 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. |
| Table Topics game | Placebo comparator | Other: Table Topics gameFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Adults (> 18 years old)
Key exclusion criteria (4 listed)
- 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
- Unable to consent to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hello for Cancer gameTo 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. | Behavioural | Hello for Cancer game |
| Table Topics gameTo 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'). | Other | Table Topics game |
Primary outcome
Perceptions of modified intervention
Time frame: immediately post-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.
Healthcare Utilization
Time frame: Baseline to up to two years after participation in research event
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.
5 secondary outcomes
Advance Care Planning Engagement Measure
Time frame: Baseline
Advance Care Planning Surrogate Decision Maker Engagement Measure
Time frame: Baseline
Satisfaction of Intervention Measure
Time frame: Immediately post-intervention
Acceptability of Intervention Measure
Time frame: Immediately post-intervention
Preliminary efficacy of Hello on ACP behaviors.
Time frame: Event follow-up interview (one to four months post event)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Van Scoy, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hello for Cancer game and Table Topics game 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 4 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 21 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
Perceptions of modified intervention (time frame: immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.