An interventional study of Adapted patient navigation program targeting adolescent and young adult cancer survivors in Breast Cancer, Ovarian Cancer and Cervical Cancer, sponsored by Kaiser Permanente. Recruiting at 1 site in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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The investigators propose to: 1) Adapt an evidence-based cancer-focused patient navigation (PN) program for the Adolescent and Young Adult (AYA) cancer survivor population; and 2) Plan and conduct an effectiveness-implementation trial of this program within Kaiser Permanente Southern California (KPSC). PLEASE NOTE: This study is awarded in two phases. The UG3 phase has been awarded for the first two years; upon successful completion of this phase by meeting pre-defined milestones, the National Cancer Institute (NCI) will provide funding for the second phase of the study (Years 3-6), which will allow our team to conduct a trial to determine the effectiveness of the implementation of the adapted PN program for the AYA cancer survivor population. This application is focused on the initial UG3 phase and will update the protocol for the UH3 trial upon successful completion of the UG3 milestones and receipt of the UH3 award.
The primary objectives in the UG3 phase of the study are to adapt and tailor an existing PN program to meet the needs of AYA cancer survivors and the local clinical context via (a) interviews with key stakeholders (patients, clinicians, administrators) and (b) guidance from our AYA Primary Care Survivorship Council. The investigators will conduct a pilot study of the adapted PN program and refine the program to enhance acceptability to patients and clinicians, enhance feasibility and effectiveness, and develop and pilot evaluation tools and methods prior to the start of the UH3 phase of the trial, which will be a larger trial. Objectives will be updated for the UH3 phase once awarded.
In the UG3 phase, the investigators will be adapting a patient navigation (PN) intervention to suit adolescent and young adult (AYA) cancer survivors and conducting a single-site pilot test of the adapted intervention. In the UH3 phase, the investigators will conduct a pragmatic stepped wedge hybrid effectiveness implementation trial evaluating (1) clinical effectiveness and (2) implementation outcomes, across a range of data sources.
Intervention:
Navigator-level: For the pilot test in the UG3 phase, the investigators will provide PN training for the adapted AYA PN program to at least one navigator. The investigators anticipate that navigators will undergo a comprehensive training curriculum that draws on existing Kaiser Permanente Southern California (KPSC) PN program trainings and includes primary care and cancer survivorship/surveillance components and established recommendations for cancer survivorship navigation from the American Society of Clinical Oncology (ASCO) and others. These resources include core navigation competencies for survivorship, patient assessment, scope of practice, etc. These trainings will be completed with additional focus areas/domains identified during the adaptation processes. Based on the structure of the existing PN program, it is anticipated that monthly review meetings will be held.
Patient-level: For the pilot test in the UG3 phase, the investigators will identify eligible patients from a single clinical site within KPSC. The investigators anticipate enrolling 15-25 patients in the pilot. Patients will receive a letter and brochure describing the adapted AYA PN program with a bio of their assigned navigator and how the program will help integrate primary care and cancer survivorship needs. It is strongly anticipated that navigation 'touches' will include progressive steps via a combination of delivery modes as with the existing PN programs: 1) email: patients with KP.org patient portal accounts will receive email communication from navigators; 2) text: patients with registered mobile phone in KP membership files will receive text-based communications; 3) calls: patients will receive calls from their navigator to discuss scheduling, overdue recommended care, and motivational coaching; 4) letters: patients may receive letters if unable to be reached via email, text, and calls. Navigators will work with the electronic medical record (EMR) to identify need for recommended healthcare services and gaps in care, working with the care team to pend orders for physician review and work directly with the patient using motivational interviewing skills to encourage participation in care, address social needs, and identify care goals. PN program milestones, developed based on established recommendations for survivorship navigation metrics and the input from our adaptation processes, will likely include patients contacted, engagement activities, and pending orders for physician review for overdue services.
System-level: As part of the UG3 phase, the investigators will work closely with our partners to adapt the PN program to suit existing clinical needs and workflows. 2-3 focus groups will be held with care teams (nurses/physicians/advanced practice providers) and department administrators (DAs) using a semi-structured focus group format. These groups will provide feedback on the team-based care focus for the PN program, how to integrate seamlessly into existing clinical workflows, suggestions for use and/or expansion of existing KPSC information technology (IT) tools (e.g., the Complete Care Model tools), and clinical needs of the patient population. Using adapted health IT tools, flags may be created for patients due for recommended services.
In the UG3 phase, the study will open enrollment for the prospective single-arm pilot study by month 18, after focus group data and program adaptation is complete. Completion of data collection for the pilot is estimated at month 24.
In the UG3 phase, the patients in the single site pilot will complete all study tasks by 6 months.
Following the structure of the NCI two-phase cooperative agreement, the investigators propose to: 1) Adapt an existing evidence-based, cancer-focused PN program to the AYA survivor population and to the clinical setting; and 2) Conduct a pragmatic stepped wedge hybrid type 2 effectiveness-implementation trial within a large integrated healthcare system, Kaiser Permanente Southern California (KPSC). The investigators hypothesize that the adapted PN program will lead to increased uptake of high-quality, guideline-recommended primary care and cancer surveillance services for AYA survivors (clinical outcomes), and high levels of acceptability, appropriateness, feasibility, adoption, penetration, fidelity, and sustainment. The investigators have defined measurable, feasible milestones for both the UG and UH phases of the proposal.
The UG3 phase is a three-step process to achieve study goals:
Step 1: rigorous exploration and documentation of adaptation processes via a combined use of implementation and adaptation frameworks, representing a significant contribution to the field. Intentional adaptation provides an opportunity for implementation flexibility, potentially improving the overall fit of an evidence-based intervention to a new population and/or context (Kirk et. al, 2020), such as AYA survivors care in the primary care setting. Several adaptation frameworks have been proposed over the past decade, with a collective recognition of the importance of rigorous research on adaptation processes and the distinction between the function (e.g., core elements) and form (e.g., delivery type) of evidence-based interventions. The investigators will follow the overarching steps of adaptation processes with extensive stakeholder engagement throughout. The investigators will supplement this with a novel application of the RE-AIM framework for guidance on the 'who, why, how' of adaptation a nascent and exciting application of RE-AIM to adaptation processes. The investigators will use the FRAME to guide thorough documentation of adaptation activities throughout the eleven steps. This blend of Escoffery's eleven steps, RE-AIM, and FRAME provides a stepwise, thoughtful approach for capturing the rationale for adaptation, the internal and external context of adaptation, and for cataloguing adaptation elements.
Recent work from leaders in the field have combined RE-AIM with adaptation frameworks, although not in this specific combination which is more appropriate to address our research questions. The investigators propose a multilevel adaptation process, tailoring PN program components to meet the needs of AYA cancer survivors, primary care teams, and the organizational setting (and leveraging available supportive resources). The investigators will be adapting KPSC's existing PN program for patients newly diagnosed with cancer, which includes KPSC's robust 'Complete Care' model and health IT tools shown to be effective at managing cancer (diagnosis and initial treatment) and other chronic conditions. Step 2: conduct a pilot study of the adapted PN program with a single clinic, collecting patient, clinician, and clinic-level data and iteratively refining the PN program as appropriate. Step 3: develop our trial manual of operations and obtain administrative and other approvals so that the trial is set to launch at start of Year 3.
In the UH3 phase, the investigators will conduct a pragmatic stepped wedge hybrid type 2 effectiveness-implementation trial with extensive quantitative and qualitative process evaluation activities to examine mechanisms of effect, moderators and other contextual factors. This protocol will be updated once the UH3 phase is awarded.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
This study's planned enrollment of 25 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The primary objectives in the UG3 phase of the study are to adapt and tailor an existing patient navigation program to meet the needs of AYA cancer survivors and the local clinical context. Adolescent and young adult cancer survivors will be enrolled in a single arm pilot study of the adapted navigation program.
Behavioral: Adapted patient navigation program targeting adolescent and young adult cancer survivors
In the UG3 phase, the investigators will be adapting a patient navigation intervention to suit adolescent and young adult cancer survivors and conducting a single-site pilot test of the adapted intervention. The investigators will conduct a pilot test of the adapted AYA PN program at a single participating site, focusing on the perceptual implementation outcomes of acceptability, appropriateness, and feasibility and the hypothesized patient navigation program outcomes of increased motivation, capability, and opportunity for care. The pilot will also include testing of the patient identification algorithm, patient enrollment/engagement methods, clinical workflow, survey recruitment methods, and health IT elements (e.g., access, ease of use).
Perceived Health Competence Scale
Patient survey outcome; 8 items measured on a Likert scale (1-5) with higher scores associated with higher health competence
Time frame: From enrollment to completion at 6 months post-enrollment
Weiner's Appropriateness, Acceptability, and Feasibility
Patient Survey Outcome measured on a 5-item Likert scale of agreement (1=low, 5=high) for each of the three constructs (appropriateness, acceptability, feasibility) with 4 questions per construct. Average score will be created for each construct. No items are reverse coded.
Time frame: From enrollment to completion at 6 months post-enrollment
Weiner's Appropriateness, Acceptability, and Feasibility
Clinician/Administrator Survey Outcome, measured on a 5-item Likert scale of agreement (1=low, 5=high) for each of the three constructs (appropriateness, acceptability, feasibility) with 4 questions per construct. Average score will be created for each construct. No items are reverse coded.
Time frame: Baseline to 6 months post-patient enrollment into navigation program
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 15 months is below that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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