Trial Title:
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2
NCT ID:
NCT06384417
Condition:
Breast Cancer
Lung Cancer
Genito-Urinary Cancer
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Liver Cancer
Head and Neck Cancer
Melanoma
Conditions: Official terms:
Urogenital Neoplasms
Conditions: Keywords:
Advance Care Planning
Advance Directives
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Intervention:
Intervention type:
Behavioral
Intervention name:
Hello for Cancer game
Description:
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.
Arm group label:
Hello for Cancer game
Intervention type:
Other
Intervention name:
Table Topics game
Description:
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').
Arm group label:
Table Topics game
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Penn State Cancer Institute
Address:
City:
Hershey
Zip:
17033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Hayes, PhD
Phone:
717-531-8521
Email:
mhayes3@pennstatehealth.psu.edu
Investigator:
Last name:
Michael Hayes, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Monika Joshi
Email:
Sub-Investigator
Start date:
June 27, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Milton S. Hershey Medical Center
Agency class:
Other
Source:
Milton S. Hershey Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06384417
