Navigation Intervention for Adolescent and Young Adult Cancer Survivors

NCT07406087 | Not Yet Recruiting

• 2 other identifiers: UG3CA2977051UG3CA297705-01A1
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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; Melanoma (Skin Cancer); Endometrial Cancer; Sarcoma; Thyroid Cancer

Keywords

Adolescent and Young Adult; Cancer Survivors; Patient Navigation; Adaptations; Implementation 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 survivors BEHAVIORAL

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

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Related Publications (21)

• Nekhlyudov L, O'Malley D M, Hudson SV. Integrating primary care providers in the care of cancer survivors: gaps in evidence and future opportunities. Lancet Oncol. Jan 2017;18(1):e30-e38. doi:10.1016/S1470-2045(16)30570-8

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• McCabe MS, Partridge AH, Grunfeld E, Hudson MM. Risk-based health care, the cancer survivor, the oncologist, and the primary care physician. Seminars in oncology. Dec 2013;40(6):804-12. doi:10.1053/j.seminoncol.2013.09.004

  BACKGROUND

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• Kirsty L, Shaun T, Frank S, Peter D, Kevin ET, Merrick Z. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ : British Medical Journal. 2015;350:h2147. doi:10.1136/bmj.h2147

  BACKGROUND

• 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. Medical care. 2012;50(3):217-226. doi:10.1097/MLR.0b013e3182408812

  BACKGROUND

• Kanter MH LG, Bellows J, Chase A. Complete care at Kaiser Permanente: transforming chronic and preventive care. The Joint Commission Journal on Quality and Patient Safety. 2013;39(11):484-94.

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• 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. American journal of preventive medicine. Jul 2016;51(1):71-7. doi:10.1016/j.amepre.2015.11.014

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• Cohen AJ, Russell LE, Elwy AR, et al. Adaptation of a social risk screening and referral initiative across clinical populations, settings, and contexts in the Department of Veterans Affairs Health System. Original Research. Frontiers in Health Services. 2023;2

  BACKGROUND

• Rabin BA, McCreight M, Battaglia C, et al. Systematic, Multimethod Assessment of Adaptations Across Four Diverse Health Systems Interventions. Methods. Frontiers in Public Health. 2018;6

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

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• Chambers DA. Advancing adaptation of evidence-based interventions through implementation science: progress and opportunities. Perspective. Frontiers in Health Services. 2023;3

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  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Testicular Neoplasms; Colonic Neoplasms; Melanoma; Endometrial Neoplasms; Sarcoma; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms, Connective and Soft Tissue; Head and Neck Neoplasms; Thyroid 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

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

Corrine E. Munoz-Plaza, MPH

CONTACT

626-564-3094; Corrine.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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share