Clinical trial · Interventional
Navigation Intervention for Adolescent and Young Adult Cancer Survivors
Adaptation and Implementation of an Evidence-Based Patient Navigation Intervention for Adolescent and Young Adult Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colon Rectal Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adapted patient navigation program targeting adolescent and young adult cancer survivors | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adapted Patient Navigation Program
- description
- 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.
- interventionNames
- Behavioral: Adapted patient navigation program targeting adolescent and young adult cancer survivors
Primary outcomes (1)
- measure
- Perceived Health Competence Scale
- timeFrame
- From enrollment to completion at 6 months post-enrollment
- description
- Patient survey outcome; 8 items measured on a Likert scale (1-5) with higher scores associated with higher health competence
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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 diagnosisReferences
Publications (21)
- BACKGROUNDNekhlyudov L, O'malley DM, Hudson SV. Integrating primary care providers in the care of cancer survivors: gaps in evidence and future opportunities. Lancet Oncol. 2017 Jan;18(1):e30-e38. doi: 10.1016/S1470-2045(16)30570-8. PMID 28049575
- BACKGROUNDMcCabe MS, Partridge AH, Grunfeld E, Hudson MM. Risk-based health care, the cancer survivor, the oncologist, and the primary care physician. Semin Oncol. 2013 Dec;40(6):804-12. doi: 10.1053/j.seminoncol.2013.09.004. PMID 24331199
- BACKGROUNDDiMartino L LP, Mittman B. Increasing the quantity and quality of coordinating center activity in implementation science: A novel application of core function/form concepts. . presented at: Paper accepted at 16th Annual Conference on the Science of Dissemination and implementation; December 10-13, 2023 Washington, DC;.
- BACKGROUNDLengnick-Hall R, Stadnick NA, Dickson KS, Moullin JC, Aarons GA. Forms and functions of bridging factors: specifying the dynamic links between outer and inner contexts during implementation and sustainment. Implement Sci. 2021 Apr 1;16(1):34. doi: 10.1186/s13012-021-01099-y. PMID 33794956
- BACKGROUNDEsmail LC, Barasky R, Mittman BS, Hickam DH. Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI). J Gen Intern Med. 2020 Nov;35(Suppl 2):875-881. doi: 10.1007/s11606-020-06093-6. Epub 2020 Oct 26. PMID 33107006
- BACKGROUNDPerez Jolles M, Lengnick-Hall R, Mittman BS. Core Functions and Forms of Complex Health Interventions: a Patient-Centered Medical Home Illustration. J Gen Intern Med. 2019 Jun;34(6):1032-1038. doi: 10.1007/s11606-018-4818-7. Epub 2019 Jan 8. PMID 30623387
- BACKGROUNDKhor S, Heagerty PJ, Basu A, Haupt EC, Lyons LJL, Hahn EE, Bansal A. Racial Disparities in the Ascertainment of Cancer Recurrence in Electronic Health Records. JCO Clin Cancer Inform. 2023 Jun;7:e2300004. doi: 10.1200/CCI.23.00004.