Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384417
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-22
Brief Title:
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning Phase 2
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Adapting an Advance Care Planning Intervention for Use With Patients With Cancer and Their Care Partners Phase Two
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 various solid cancer types including breast gastro-intestinal lung melanoma head and neck andor 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 andor adaptations are necessary to Hello for use in cancer populations
What impact does participation in Hello event have on health care usage eg 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
What modifications andor adaptations are necessary to Hello for use in cancer populations
What impact does participation in Hello event have on health care usage eg 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 Institutes 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 ie clinic-based recruitment as the ACP intervention is recommended by the patients 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
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 Institutes 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 ie clinic-based recruitment as the ACP intervention is recommended by the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None