Understanding Needs of Older Patients Prior to Starting Cancer Treatment
PGA
Practical Delivery of Geriatric Assessment in Community Oncology Settings (PGA)
3 other identifiers
interventional
216
2 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2025
CompletedFirst Posted
Study publicly available on registry
November 10, 2025
CompletedStudy Start
First participant enrolled
January 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 8, 2026
April 1, 2026
1.1 years
November 6, 2025
April 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Qualitative feedback on the practical geriatric assessment (PGA) implementation strategies within the context of the National Cancer Institute Community Oncology Research Program (Part 1)
Thematic analysis will be used to identify suggested modifications that could be used to optimize acceptability of PGA implementation strategies. Intervention materials and implementation strategies will then be refined based on this feedback for further evaluation in the Part 2 Pilot Study.
Up to 6 months after the start of Part 1
Acceptability of PGA implementation strategies (Part 2)
Acceptability of PGA implementation strategies will be assessed qualitatively during the clinic debrief meeting for those able to attend the meeting. If a participant is unable to attend the meeting, acceptability will instead be assessed quantitatively using the Acceptability of Intervention Measure (AIM) via a REDCap survey. In this case, acceptability will be defined as a score of at least 4 on the AIM. Overall, PGA implementation strategies will be considered acceptable if the majority of participants at the debrief meeting for each clinic agree that the strategies are acceptable. If this metric is not met, strategies will be further refined before the start of the future randomized trial.
6 months after the start of Part 2
Secondary Outcomes (7)
Key mechanisms, intervention components, facilitators, and barriers that could inform future implementation strategies and potential modifications (Part 1)
Up to 6 months after the start of Part 1
Patient participation rate (Part 2)
Up to 6 months after the start of Part 2
Patient survey response rate (Part 2)
Up to 6 months after the start of Part 2
Appropriateness of the PGA implementation strategies (Part 2)
6 months after the start of Part 2
Feasibility of completing the PGA with implementation strategies (Part 2)
6 months after the start of Part 2
- +2 more secondary outcomes
Study Arms (2)
Part 1 (stakeholder interview)
EXPERIMENTALParticipants 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 (PGA education, management, and support EHR review)
EXPERIMENTALSee Detailed Description
Interventions
Complete interest survey
Receive provider education
Start or increase PGA and GA management
Attend virtual meetings
Complete EHR reviews
Eligibility Criteria
You may qualify if:
- 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
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 39705, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southaven, Mississippi, 38671, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284, United States
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961, United States
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904, United States
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166, United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981, United States
Doctors Cancer Center
ManatÃ, 00674, Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
PROncology
San Juan, 00927, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kathryn Weaver, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No Data Available
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2025
First Posted
November 10, 2025
Study Start
January 14, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon request to NCORP@wfusm.edu
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.