Navigation Intervention for Adolescent and Young Adult Cancer Survivors
- Sponsor
- Kaiser Permanente
- Study ID
- NCT07406087
- Status
- Not Yet Recruiting
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Conditions
- Breast Cancer
- Cervical Cancer
- Colon Rectal Cancer
- Endometrial Cancer
- Melanoma (Skin Cancer)
- Ovarian Cancer
- Sarcoma
- Testicular Cancer
- Thyroid Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 45 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adapted patient navigation program targeting adolescent and young adult cancer survivors — BEHAVIORALIn 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).
Study Details
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.
Key Dates
- Start date
- Nov 1, 2026
- Status verified
- Feb 2026
- Primary completion
- May 30, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Adapted Patient Navigation ProgramThe 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.
Primary Outcome Measure
Perceived Health Competence Scale [ Time Frame: From enrollment to completion at 6 months post-enrollment ]
Central Contacts
- Erin E Hahn, PhD626-564-3505
- Corrine E. Munoz-Plaza, MPH626-564-3094
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