Hematopoietic and Lymphatic System NeoplasmPGANCT07225920
Understanding Needs of Older Patients Prior to Starting Cancer Treatment
A study testing Survey Administration, Interview and Educational Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Wake Forest University Health Sciences at 42 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Survey Administration, Interview and Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 42 sitesin 2 countries
- Study dates
- 14 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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 PGA Abstraction.
- 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 or accepted alternatives 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
Who cannot join
None listed.
Trial locations and contacts
42 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
42 sites in 2 countries
United States39 sites
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Chelsea Hospital
Chelsea, Michigan, 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Mercy Hospital Joplin
Joplin, Missouri, 64804
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 39705
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961
Helen F Graham Cancer Center
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Lake Regional Hospital
Osage Beach, Missouri, 65065
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, 87124
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166
Baptist Memorial Hospital and Cancer Center-Desoto
Southaven, Mississippi, 38671
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Puerto Rico3 sites
Doctors Cancer Center
Manati, 00674
Centro Comprensivo de Cancer de UPR
San Juan, 00927
PROncology
San Juan, 00927
About this study
Official title: Practical Delivery of Geriatric Assessment in Community Oncology Settings (PGA)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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)
- 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, 10-15 EHR PGA abstractions will be completed by staff per practice on these patients who received full or partial PGA and 30-45 medical record reviews will be completed by staff per practice each patient enrolled in Part 2 on study. Finally, Clinic Champions, local providers, and staff complete a final debrief meeting to discuss the implementation of PGA in the clinic.
- Being tested
- Survey Administration, Interview, Educational Intervention, Assessment, Internet-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete interest survey
InterviewOther
Complete stakeholder interview
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive provider education
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive written and/or electronic materials on PGA delivery
AssessmentOther
Also called Assess, Assessment, assessment, assessment, assessment, Study Assessment, Study Observation
Start or increase PGA and GA management
Internet-Based InterventionOther
Attend virtual meetings
Electronic Health Record ReviewOther
Complete EHR PGA abstractions and medical record reviews
Survey AdministrationOther
Ancillary Studies (Patient Survey)
InterviewOther
Ancillary studies (Patient Interview)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (stakeholder interview) | Experimental | 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. Receives: Other: Survey Administration; Other: Interview |
| Part 2 (PGA education, management, and support EHR review) | Experimental | See Detailed Description Receives: Other: Survey Administration; Other: Educational Intervention; Other: Assessment; Other: Internet-Based Intervention; Other: Electronic Health Record Review; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (indicating agree to strongly agree). 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.
Measured: 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)
Thematic analysis will be used to identify key mechanisms, intervention components, facilitators, and barriers across different contextual settings that could inform future implementation strategies and potential modifications. There will be a focus on relevance for all patients and settings.
Measured: Up to 6 months after the start of Part 1
Patient participation rate (Part 2)
A patient will be considered consented and enrolled when he or she is entered in Oncology Patient Enrollment Network. The participation rate will be calculated as the proportion of approached eligible patients (based on the WF-2501CD PGA Screening Project) who are consented and enrolled. If the participation rate is < 50%, the outreach strategies will be refined prior to starting the future randomized trial.
Measured: Up to 6 months after the start of Part 2
Patient survey response rate (Part 2)
The one-time patient survey will be considered completed if the patient completes all survey items. The response rate will then be calculated as proportion of consented and enrolled patients who complete the survey. If the response rate is < 50%, the survey will be refined prior to starting the future randomized trial.
Measured: Up to 6 months after the start of Part 2
Appropriateness of the PGA implementation strategies (Part 2)
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, appropriateness will instead be assessed quantitatively using the Intervention Appropriateness Measure (IAM) via a REDCap survey. In this case implementation strategies will be considered appropriate if the IAM score is at least 4. If the majority of participants at the debrief meeting for each clinic do not agree on appropriateness, further refinements will be made before the start of the future randomized trial.
Measured: 6 months after the start of Part 2
Feasibility of completing the PGA with implementation strategies (Part 2)
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, feasibility will instead be assessed quantitatively using the Feasibility of Intervention Measure (FIM) via a REDCap survey. In this case implementation strategies PGA will be considered feasible if the FIM score is at least 4. If the majority of participants at the debrief meeting for each clinic do not agree on feasibility, further refinements will be made before the start of the future randomized trial.
Measured: 6 months after the start of Part 2
Refined electronic health record (EHR) data abstraction process (Part 2)
To refine the process for EHR data abstraction to be used in the future randomized trial, the following data elements will be summarized: PGA domains that are documented, where in the EHR the PGA domains are documented, PGA guided actions that are documented, and where in the EHR the PGA guided actions are documented. "Raw" de-identified clinical notes will also be reviewed to confirm whether the training provided on data abstraction was sufficient.
Measured: Up to 6 months after the start of Part 2
Patient perspective of the PGA process (Part 2)
To further evaluate the PGA process from the patient perspective to inform the future randomized trial, thematic analysis will be used to summarize the PGA experience from the patient perspective based on qualitative interviews.
Measured: Up to 6 months after the start of Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start14 Jan 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The primary objective of Part 1 is to refine proposed implementation strategies for delivering PGA through qualitative feedback from stakeholders. The primary objective of Part 2 is to assess the acceptability of the PGA implementation strategies, as perceived by the 3 pilot practices.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225920
- Sponsor's protocol ID
- IRB00139618
- Other IDs
- NCI-2025-07328, WF-2501CD, WF-2501CD, WF-2501CD
- Acronym
- PGA
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Delivery of Geriatric Assessment in Community Oncology Settings (PGA)
- ClinicalTrials.gov ID
- NCT07225920
- Acronym / sponsor ID
- PGA / IRB00139618
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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)
- 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, 10-15 EHR PGA abstractions will be completed by staff per practice on these patients who received full or partial PGA and 30-45 medical record reviews will be completed by staff per practice each patient enrolled in Part 2 on study. Finally, Clinic Champions, local providers, and staff complete a final debrief meeting to discuss the implementation of PGA in the clinic.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary objective of Part 1 is to refine proposed implementation strategies for delivering PGA through qualitative feedback from stakeholders. The primary objective of Part 2 is to assess the acceptability of the PGA implementation strategies, as perceived by the 3 pilot practices.
| Arm | Type | Receives |
|---|---|---|
| Part 1 (stakeholder interview) | Experimental | Other: Survey Administration, Other: InterviewParticipants 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) | Experimental | Other: Survey Administration, Other: Educational Intervention, Other: Assessment, Other: Internet-Based Intervention, Other: Electronic Health Record Review, Other: InterviewSee Detailed Description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete interest survey | Other | Part 1 (stakeholder interview), Part 2 (PGA education, management, and support EHR review) |
| InterviewComplete stakeholder interview | Other | Part 1 (stakeholder interview) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive provider education | Other | Part 2 (PGA education, management, and support EHR review) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive written and/or electronic materials on PGA delivery | Other | Part 2 (PGA education, management, and support EHR review) |
| AssessmentAlso: Assess, Assessment, assessment, assessment, assessment, Study Assessment, Study ObservationStart or increase PGA and GA management | Other | Part 2 (PGA education, management, and support EHR review) |
| Internet-Based InterventionAttend virtual meetings | Other | Part 2 (PGA education, management, and support EHR review) |
| Electronic Health Record ReviewComplete EHR PGA abstractions and medical record reviews | Other | Part 2 (PGA education, management, and support EHR review) |
| Survey AdministrationAncillary Studies (Patient Survey) | Other | Part 2 (PGA education, management, and support EHR review) |
| InterviewAncillary studies (Patient Interview) | Other | Part 2 (PGA education, management, and support EHR review) |
Primary outcome
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
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.
Acceptability of PGA implementation strategies (Part 2)
Time frame: 6 months after the start of 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 (indicating agree to strongly agree). 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn Weaver, PhD study chair
Wake Forest University Health Sciences
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Administration, Interview and Educational Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Wake Forest University Health Sciences at 42 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.