NCT07225920

Understanding Needs of Older Patients Prior to Starting Cancer Treatment

Enrolling by Invitation
NAAges 18+InterventionalHealth services
Wake Forest University Health Sciences
~216 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Survey AdministrationInterviewEducational InterventionAssessmentInternet-Based InterventionElectronic Health Record Review

At a glance

Recruiting sites
0 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Qualitative feedback on the practical geriatric assessment (PGA) implementation strategies within the context of the National Cancer Institute Community Oncology Research Program (Part 1)
Measured over Up to 6 months after the start of Part 1
+1 more outcome measured
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
27 sites across 9 states
Michigan5
Mississippi5
Wisconsin5
Tennessee3
Puerto Rico3
Arkansas2
North Carolina2
Alabama1
  • Kathryn Weaver, PhD · STUDY_CHAIR · Wake Forest University Health Sciences

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
  • Qualitative feedback on the practical geriatric assessment (PGA) implementation strategies within the context of the National Cancer Institute Community Oncology Research Program (Part 1)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)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. 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.