Understanding Needs of Older Patients Prior to Starting Cancer Treatment

Official title

Practical Delivery of Geriatric Assessment in Community Oncology Settings (PGA)

Overview

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.

Interventions

• Other Survey Administration
  Complete interest survey
• Other Interview
  Complete stakeholder interview
• Other Educational Intervention
  Receive provider education
• Other Educational Intervention
  Receive written and/or electronic materials on PGA delivery
• Other Assessment
  Start or increase PGA and GA management
• Other Internet-Based Intervention
  Attend virtual meetings
• Other Electronic Health Record Review
  Complete EHR reviews
• Other Survey Administration
  Ancillary Studies (Patient Survey)
• Other Interview
  Ancillary studies (Patient Interview)

Primary outcome measures

• Qualitative feedback on the practical geriatric assessment (PGA) implementation strategies within the context of the National Cancer Institute Community Oncology Research Program (Part 1) [Time frame: Up to 6 months after the start of Part 1]
• Acceptability of PGA implementation strategies (Part 2) [Time frame: 6 months after the start of Part 2]

Secondary outcome measures (7)

• Key mechanisms, intervention components, facilitators, and barriers that could inform future implementation strategies and potential modifications (Part 1) [Time frame: Up to 6 months after the start of Part 1]
• Patient participation rate (Part 2) [Time frame: Up to 6 months after the start of Part 2]
• Patient survey response rate (Part 2) [Time frame: Up to 6 months after the start of Part 2]
• Appropriateness of the PGA implementation strategies (Part 2) [Time frame: 6 months after the start of Part 2]
• Feasibility of completing the PGA with implementation strategies (Part 2) [Time frame: 6 months after the start of Part 2]
• Refined electronic health record (EHR) data abstraction process (Part 2) [Time frame: Up to 6 months after the start of Part 2]
• Patient perspective of the PGA process (Part 2) [Time frame: Up to 6 months after the start of Part 2]

Eligibility criteria

Inclusion criteria

• PART 1 ONCOLOGY CLINICIANS: Must be an oncology clinician (MDs, DOs, APPs (e.g. NP, PA)) who administers systemic therapy (chemotherapy, immunotherapy or targeted therapy).
• PART 1 ONCOLOGY CLINICIANS: Must be involved in the planning or delivery of new systemic therapies (e.g. chemotherapy, immunotherapy, targeted therapy) to patients including those >= 65 years old
• PART 1 ONCOLOGY CLINICIANS: Must be willing to participate in a semi-structured interview (approximately 60 minutes; remotely over the internet or by phone)
• PART 1 ONCOLOGY CLINICIANS: Concurrent participation in URCC-19170 is allowed, not required
• PART 1 ONCOLOGY CLINICIANS: Must be able to read, understand and speak English
• PART 1 ONCOLOGY SUPPORT STAFF STAKEHOLDER: Nurse, practice manager, or other oncology support staff who work with oncology clinicians who provide systemic therapy, help with office workflows for patient screeners, or help patients with referrals (including patients age 65 or older). May include staff that have a dual role in research and clinical support
• PART 1 ONCOLOGY SUPPORT STAFF STAKEHOLDER: Must be willing to participate in a semi-structured interview (approximately 60 minutes; remotely over the internet or by phone)
• PART 1 ONCOLOGY SUPPORT STAFF STAKEHOLDER: Concurrent participation in URCC-19170 is allowed, not required
• PART 1 ONCOLOGY SUPPORT STAFF STAKEHOLDER: Must be able to read, understand and speak English
• PART 1 PATIENT STAKEHOLDER: >= 65 years of age
• PART 1 PATIENT STAKEHOLDER: Must have initiated a new line of chemo-/immuno- and/or targeted therapy in the last 12 months
• PART 1 PATIENT STAKEHOLDER: Must be willing to participate in a semi-structured interview (approximately 60 minutes; or remotely over the internet or by phone)
• PART 1 PATIENT STAKEHOLDER: Concurrent participation in URCC-19170 is allowed, not required
• PART 1 PATIENT STAKEHOLDER: Must be able to understand and speak English
• PART 1 CAREGIVER STAKEHOLDER: Must self-report as having cared for a patient 65 years or older who initiated systemic treatment (e.g. chemo-, immuno- and/or targeted therapy) in the last 12 months. To allow for differences in how the term "caregiver" is used, we will include any family member, significant other, or friend who helps during their cancer treatment, regardless of whether they define themselves as a caregiver
• PART 1 CAREGIVER STAKEHOLDER: Must be willing to participate in a semi-structured interview (approximately 60 minutes; remotely over the internet or by phone)
• PART 1 CAREGIVER STAKEHOLDER: Concurrent participation in URCC-19170 is allowed, not required
• PART 1 CAREGIVER STAKEHOLDER: Must be able to understand and speak English
• PART 2 PRACTICE: Must be an National Cancer Institute Community Oncology Research Program (NCORP) practice (defined as one or more NCORP affiliates/sub-affiliates, which have a common administrative structure and share providers and/or patients)
• PART 2 PRACTICE: Must provide outpatient oncology care to at least 50 new patients aged 65 or over starting a new non-hormonal systemic therapy in the past 6 months
• PART 2 PRACTICE: Must have received an Introductory Email with a Practice Identification (ID) to be used to enroll the selected affiliate/sub-affiliates in Oncology Patient Enrollment Network (OPEN)
• PART 2 PRACTICE: Concurrent participation in URCC-19170 is allowed, not required
• PART 2 CLINIC CHAMPION: Must be employed in one of the selected clinics participating in the Part 2 Pilot Study
• PART 2 CLINIC CHAMPION: Must not be planning to leave their position in the next 9 months
• PART 2 CLINIC CHAMPION: Must provide care for or interact with patients age 65+ or provide administrative leadership over one of the selected clinics participating in the Part 2 Pilot Study
• PART 2 CLINIC CHAMPION: Must be willing to lead efforts to support PGA implementation within their clinic
• PART 2 CLINIC CHAMPION: Must be willing to complete the 15-minute Initial Clinic Survey at the beginning of the Part 2 Pilot Study
• PART 2 CLINIC CHAMPION: Must be willing to participate in the Initial Clinic Visit (in-person \[preferred\] or virtual) with the Medstar Health Research Institute (MHRI) Study Team for an estimated 60-minute in-depth discussion of the protocol. While the champion may not choose to stay with the MHRI Study Team for the rest of the half-day visit, they will facilitate plans for the other parts of the half-day site visit
• PART 2 CLINIC CHAMPION: Must be willing to participate in four 30-minute (approximately \[approx.\]) virtual meetings monthly during the pilot study
• PART 2 CLINIC CHAMPION: Must be willing to disseminate study materials to other relevant clinical team members, where appropriate invite the MHRI Study Team to present to other relevant clinical team members, and share updates with the MHRI Study Team during monthly virtual meetings
• PART 2 CLINIC CHAMPION: Must be willing to oversee the selection of participants to have an EHR review
• PART 2 CLINIC CHAMPION: Must be willing to participate in a 45-minute (approx.) virtual, recorded meeting at the end of the Part 2 Pilot Study (or if unavailable to attend the meeting, must be willing to complete a survey) to provide feedback on implementation strategies and on usefulness and acceptability of implementation strategies
• PART 2 CLINIC CHAMPION: Concurrent participation in URCC-19170 is allowed, not required
• PART 2 CLINIC CHAMPION: Must be able to read, understand and speak English
• PART 2 PATIENT: Must be >= 65 years of age
• PART 2 PATIENT: Must have a start date to begin a new line of cancer non-hormonal systemic therapy (i.e., chemotherapy, immunotherapy, and/or targeted therapy). The start date will be captured at OPEN enrollment
• PART 2 PATIENT: Must be willing to complete a one-time 15-minute survey
• PART 2 PATIENT: Must have completed at least one component of PGA prior to the new non-hormonal systemic therapy initiation, as identified by the local clinic provider or staff
• PART 2 PATIENT: Concurrent participation in URCC-19170 is allowed, not required
• PART 2 PATIENT: Must be able to understand and speak English
• PART 2 CLINIC DEBRIEF MEETING/SURVEY PARTICIPANTS (NOT ALREADY ENROLLED): Must work in or with the clinic that participated in Part 2 Pilot Study
• PART 2 CLINIC DEBRIEF MEETING/SURVEY PARTICIPANTS (NOT ALREADY ENROLLED): Concurrent participation in URCC-19170 is allowed, not required
• PART 2 CLINIC DEBRIEF MEETING/SURVEY PARTICIPANTS (NOT ALREADY ENROLLED): Must be able to read, understand and speak English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 24 centers

• Lewis and Faye Manderson Cancer Center — Tuscaloosa
• Mercy Hospital Fort Smith — Fort Smith
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
• MaineHealth Maine Medical Center- Scarborough — Scarborough
• Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton
• Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton
• Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea
• Trinity Health Saint Mary Mercy Livonia Hospital — Livonia
• … and 16 more centers

Puerto Rico · 3 centers

• Doctors Cancer Center — Manati
• Centro Comprensivo de Cancer de UPR — San Juan
• PROncology — San Juan

Identifiers

NCT: NCT07225920 · IRB00139618 · NCI-2025-07328 · WF-2501CD · WF-2501CD · WF-2501CD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗