Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06028152 |
| Other study ID # |
STUDY00023029 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 31, 2023 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Milton S. Hershey Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
