Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT07225920
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07225920
Study Brief:
Protocol Section:
NCT07225920