Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07225920
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-18
First Post:
2025-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Understanding Needs of Older Patients Prior to Starting Cancer Treatment
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Practical Delivery of Geriatric Assessment in Community Oncology Settings (PGA)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
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:
PGA
Brief Summary:
A geriatric assessment (GA) is a structured approach to identifying and addressing the strengths and vulnerabilities of older adults with cancer. They can improve the quality of cancer care for older adults and lower side effects. It is recommended a GA be administered prior to the start of non-hormonal systemic therapy for all older adults. Despite these guidelines, only a small percentage of practices report administering them. The practical geriatric assessment (PGA) was developed to help oncology practices perform GAs. It aims to provide a brief way to evaluate older patients' physical health along with other important things like support network and impact to the patient's daily life. Typically, clinics do not receive extra training on delivering the PGA. Providing training and support for staff at cancer clinics may help deliver the enhanced PGA to older adult cancer patients who are starting a new-hormonal systemic therapy. This clinical trial looks at whether providing training and support for staff at cancer clinics can help them deliver patient check-ups (e.g., PGA) specifically designed for adults \>= 65 years old (older adults) starting a new non-hormonal systemic cancer therapy. The usual approach clinics use when starting these cancer therapy courses with an older adult may vary considerably.
Detailed Description:
PRIMARY OBJECTIVES:
I. To refine proposed implementation strategies for delivering PGA through qualitative feedback from stakeholders. (Part 1) II. To assess the acceptability of the PGA implementation strategies, as perceived by the 3 pilot practices. (Part 2)
SECONDARY OBJECTIVES:
I. To describe current PGA relevant processes at participating practices and to describe barriers and facilitators to PGA delivery though qualitative feedback from stakeholders to help inform future implementation strategies and options for tailoring those strategies. (Part 1)
II. To assess patient participation (defined by the proportion of approached eligible patients who consent to participate and are enrolled) and patient survey response (defined by the proportion of consented patients that complete the one-time patient survey). (Part 2)
III. To assess the appropriateness of the PGA implementation strategies and the feasibility of completing the PGA with implementation strategies as perceived by the 3 pilot practices. (Part 2)
IV. To refine the process for electronic health record (EHR) data abstraction to be used in the future randomized trial. (Part 2)
V. To further evaluate the PGA process from the patient perspective to inform the future randomized trial. (Part 2)
OUTLINE: Interested Community Site practices complete the interest survey during practice recruitment and selected practices are then assigned to participate in Part 1 and/or Part 2.
PART 1: Participants from practices selected for participation in Part 1 complete a stakeholder interview (approximately 60 minutes) to gather information on current PGA relevant processes within the practice, including any anticipated barriers or facilitators to delivery, and provide feedback on proposed implementation strategies.
PART 2: Clinic Champions and available providers and staff from practices selected for participation in Part 2 will participate in a half-day orientation session with the study team, where they will receive provider education and written and/or electronic materials on PGA delivery at baseline. They will also review the current process for PGA, review the study activities and discuss strategies for implementing PGA.
Practices then start or increase PGA management to patients \>= 65 years old who are starting a new non-hormonal systemic cancer therapy for 6 months. Clinic Champions also attend virtual monthly meetings (30-60 minutes) and receive active support to increase delivery of PGA for 6 months. Additionally, 15-35 patients will be provided a survey to capture their PGA experience, 4-10 patients will be asked to do an interview for further PGA details and 10-15 EHR reviews will be completed by staff per practice on these patients who received full or partial PGA on study. Finally, Clinic Champions, local providers, and staff complete a final debrief meeting to discuss the implementation of PGA in the clinic.
I. To refine proposed implementation strategies for delivering PGA through qualitative feedback from stakeholders. (Part 1) II. To assess the acceptability of the PGA implementation strategies, as perceived by the 3 pilot practices. (Part 2)
SECONDARY OBJECTIVES:
I. To describe current PGA relevant processes at participating practices and to describe barriers and facilitators to PGA delivery though qualitative feedback from stakeholders to help inform future implementation strategies and options for tailoring those strategies. (Part 1)
II. To assess patient participation (defined by the proportion of approached eligible patients who consent to participate and are enrolled) and patient survey response (defined by the proportion of consented patients that complete the one-time patient survey). (Part 2)
III. To assess the appropriateness of the PGA implementation strategies and the feasibility of completing the PGA with implementation strategies as perceived by the 3 pilot practices. (Part 2)
IV. To refine the process for electronic health record (EHR) data abstraction to be used in the future randomized trial. (Part 2)
V. To further evaluate the PGA process from the patient perspective to inform the future randomized trial. (Part 2)
OUTLINE: Interested Community Site practices complete the interest survey during practice recruitment and selected practices are then assigned to participate in Part 1 and/or Part 2.
PART 1: Participants from practices selected for participation in Part 1 complete a stakeholder interview (approximately 60 minutes) to gather information on current PGA relevant processes within the practice, including any anticipated barriers or facilitators to delivery, and provide feedback on proposed implementation strategies.
PART 2: Clinic Champions and available providers and staff from practices selected for participation in Part 2 will participate in a half-day orientation session with the study team, where they will receive provider education and written and/or electronic materials on PGA delivery at baseline. They will also review the current process for PGA, review the study activities and discuss strategies for implementing PGA.
Practices then start or increase PGA management to patients \>= 65 years old who are starting a new non-hormonal systemic cancer therapy for 6 months. Clinic Champions also attend virtual monthly meetings (30-60 minutes) and receive active support to increase delivery of PGA for 6 months. Additionally, 15-35 patients will be provided a survey to capture their PGA experience, 4-10 patients will be asked to do an interview for further PGA details and 10-15 EHR reviews will be completed by staff per practice on these patients who received full or partial PGA on study. Finally, Clinic Champions, local providers, and staff complete a final debrief meeting to discuss the implementation of PGA in the clinic.
Study Oversight
Has Oversight DMC:
True
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?: