NCT07406087

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
12mo left

Started Mar 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

February 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 5, 2026

Last Update Submit

July 1, 2026

Conditions

Testicular CancerMelanoma (Skin Cancer)Thyroid CancerCervical CancerColon Rectal CancerEndometrial CancerBreast CancerOvarian CancerSarcoma

Keywords

Adolescent and Young AdultCancer SurvivorsPatient NavigationAdaptationsImplementation Science

Outcome Measures

Primary Outcomes (1)

  • Perceived Health Competence Scale

    Patient survey outcome; 8 items measured on a Likert scale (1-5) with higher scores associated with higher health competence

    From enrollment to completion at 6 months post-enrollment

Secondary Outcomes (2)

  • Weiner's Appropriateness, Acceptability, and Feasibility

    From enrollment to completion at 6 months post-enrollment

  • Weiner's Appropriateness, Acceptability, and Feasibility

    Baseline to 6 months post-patient enrollment into navigation program

Study Arms (1)

Adapted Patient Navigation Program

EXPERIMENTAL

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

Interventions

Adapted patient navigation program targeting adolescent and young adult cancer survivorsBEHAVIORAL

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).

Adapted Patient Navigation Program

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KP Southern California - Department of Research & Evaluation

Pasadena, California, 91101, United States

RECRUITING

Related Publications (21)

  • Nekhlyudov 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: 28049575BACKGROUND

  • McCabe 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: 24331199BACKGROUND

  • DiMartino 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;.

    BACKGROUND

  • Lengnick-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: 33794956BACKGROUND

  • Esmail 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: 33107006BACKGROUND

  • Perez 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: 30623387BACKGROUND

  • Khor 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.

    PMID: 37267516BACKGROUND

  • Hahn EE, Munoz-Plaza CE, Pounds D, Lyons LJ, Lee JS, Shen E, Hong BD, La Cava S, Brasfield FM, Durna LN, Kwan KW, Beard DB, Ferreira A, Padmanabhan A, Gould MK. Effect of a Community-Based Medical Oncology Depression Screening Program on Behavioral Health Referrals Among Patients With Breast Cancer: A Randomized Clinical Trial. JAMA. 2022 Jan 4;327(1):41-49. doi: 10.1001/jama.2021.22596.

    PMID: 34982119BACKGROUND

  • Xie F, Lee J, Munoz-Plaza CE, Hahn EE, Chen W. Application of Text Information Extraction System for Real-Time Cancer Case Identification in an Integrated Healthcare Organization. J Pathol Inform. 2017 Dec 14;8:48. doi: 10.4103/jpi.jpi_55_17. eCollection 2017.

    PMID: 29416911BACKGROUND

  • Cook AJ, Delong E, Murray DM, Vollmer WM, Heagerty PJ. Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials. 2016 Oct;13(5):504-12. doi: 10.1177/1740774516646578. Epub 2016 May 13.

    PMID: 27179253BACKGROUND

  • NIH Pragmatic Trials Collaboratory. Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Accessed on 1/30/2024: https://rethinkingclinicaltrials.org/.

    BACKGROUND

  • Tuzzio L, Larson EB. The Promise of Pragmatic Clinical Trials Embedded in Learning Health Systems. EGEMS (Wash DC). 2019 Apr 3;7(1):10. doi: 10.5334/egems.285.

    PMID: 30972359BACKGROUND

  • Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.

    PMID: 25956159BACKGROUND

  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PMID: 22310560BACKGROUND

  • Kanter MH, Lindsay G, Bellows J, Chase A. Complete care at Kaiser Permanente: transforming chronic and preventive care. Jt Comm J Qual Patient Saf. 2013 Nov;39(11):484-94. doi: 10.1016/s1553-7250(13)39064-3.

    PMID: 24294676BACKGROUND

  • Henry SL, Shen E, Ahuja A, Gould MK, Kanter MH. The Online Personal Action Plan: A Tool to Transform Patient-Enabled Preventive and Chronic Care. Am J Prev Med. 2016 Jul;51(1):71-7. doi: 10.1016/j.amepre.2015.11.014. Epub 2016 Jan 27.

    PMID: 26826751BACKGROUND

  • Cohen AJ, Russell LE, Elwy AR, Mitchell KM, Cornell PY, Silva JW, Moy E, Kennedy MA. Adaptation of a social risk screening and referral initiative across clinical populations, settings, and contexts in the Department of Veterans Affairs Health System. Front Health Serv. 2023 Jan 30;2:958969. doi: 10.3389/frhs.2022.958969. eCollection 2022.

    PMID: 36925883BACKGROUND

  • Rabin BA, McCreight M, Battaglia C, Ayele R, Burke RE, Hess PL, Frank JW, Glasgow RE. Systematic, Multimethod Assessment of Adaptations Across Four Diverse Health Systems Interventions. Front Public Health. 2018 Apr 9;6:102. doi: 10.3389/fpubh.2018.00102. eCollection 2018.

    PMID: 29686983BACKGROUND

  • Escoffery C, Lebow-Skelley E, Udelson H, Boing EA, Wood R, Fernandez ME, Mullen PD. A scoping study of frameworks for adapting public health evidence-based interventions. Transl Behav Med. 2019 Jan 1;9(1):1-10. doi: 10.1093/tbm/ibx067.

    PMID: 29346635BACKGROUND

  • Chambers DA. Advancing adaptation of evidence-based interventions through implementation science: progress and opportunities. Front Health Serv. 2023 Jun 5;3:1204138. doi: 10.3389/frhs.2023.1204138. eCollection 2023.

    PMID: 37342795BACKGROUND

  • Kirk MA, Moore JE, Wiltsey Stirman S, Birken SA. Towards a comprehensive model for understanding adaptations' impact: the model for adaptation design and impact (MADI). Implement Sci. 2020 Jul 20;15(1):56. doi: 10.1186/s13012-020-01021-y.

    PMID: 32690104BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsUterine Cervical NeoplasmsTesticular NeoplasmsColonic NeoplasmsMelanomaEndometrial NeoplasmsSarcomaThyroid Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms, Connective and Soft TissueHead and Neck NeoplasmsThyroid Diseases

Study Officials

  • Erin E Hahn, PhD

    Kaiser Permanente Southern California, Department of Research & Evaluation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin E Hahn, PhD

CONTACT

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

Corrine E. Munoz-Plaza, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: After input from focus groups, the investigators will conduct a prospective, single-arm pilot study of the adapted navigation program and refine the program to enhance acceptability to patients and clinicians, enhance feasibility and effectiveness, and develop and pilot pragmatic trial evaluation tools and methods prior to the start of the UH3 phase of the trial, which will be a pragmatic stepped wedge prospective trial. Objectives will be updated for the UH3 phase once awarded.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)