Recruiting

Patient Navigation

Sponsor:

Kaiser Permanente

Code:

NCT07406087

Conditions

Breast Cancer

Ovarian Cancer

Cervical Cancer

Testicular Cancer

Colon Rectal Cancer

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Not accepted

Interventions

Adapted patient navigation program targeting adolescent and young adult cancer survivors

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Ovarian Cancer

Cervical Cancer

Testicular Cancer

Colon Rectal Cancer

Study ID

NCT07406087

Start date

Mar 15, 2026

Status verified date

Feb, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Received diagnosis of local or regional breast, ovarian, cervical, testicular, colon/rectal, melanoma, endometrial, sarcoma, or thyroid cancer between the ages of 15-39 years ("index cancer")
  • Current age 21-45 years
  • Diagnosed and treated for index cancer within Kaiser Permanente Southern California adult medical oncology and/or surgery
  • Current Kaiser Permanente insurance coverage

Exclusion Criteria:

  • Patients with a history of or current diagnosis of leukemia or lymphoma
  • Patients with metastatic disease at diagnosis

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Adapted Patient Navigation Program

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.

Interventions

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).

Primary outcome measure

  • Perceived Health Competence Scale [ Time Frame: From enrollment to completion at 6 months post-enrollment ]

Central Contacts and Locations

Central contacts

Erin E Hahn, PhD

626-564-3505Erin.E.Hahn@kp.org

Corrine E. Munoz-Plaza, MPH

626-564-3094Corrine.E.Munoz-Plaza@kp.org

Locations

KP Southern California - Department of Research & Evaluation

Recruiting

Pasadena, California, United States, 91101

More Information

Sponsor

Kaiser Permanente

Last update posted

Jul 6, 2026

Last verified

Feb, 2026

Keywords

  • Adolescent and Young Adult
  • Cancer Survivors
  • Patient Navigation
  • Adaptations
  • Implementation Science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-07-06.