Feasibility Pilot of AYA-PARTNER

NCT07829146 | Not Yet Recruiting DMC

• 1 other identifier: LCCC2618
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized feasibility pilot study of an adapted Adolescent and Young Adult Patient Advocacy, Real-Time Navigation, Equity and Reach (AYA-PARTNER) intervention for young adults ages 18-39 receiving systemic cancer treatment at the University of North Carolina at Chapel Hill (UNC) and UNC Rex and affiliated clinics. The study will use information from the electronic health record to identify young adults who may have unmet needs during cancer treatment. Examples include emergency or urgent care visits, missed appointments, no activation of the patient portal (MyChart), or treatment plans that may cause significant side effects. A trained study navigator will confirm eligibility, obtain informed consent, and provide personalized support for 4 months. The navigator will contact participants at least once each month by phone, text message, email, MyChart, or video, based on participant preference. Support may include connecting participants with supportive care services and sharing concerns with their oncology care team. The study will enroll 30 participants over 12 months, with a total study duration of 24 months. Participants will complete a needs assessment at the start of the study and again at 4 months, as well as a survey about their experience with the intervention at 4 months. The main goal of the study is to determine whether the intervention is feasible, measured by the percentage of participants who complete the 4-month survey. The study will consider the intervention feasible if at least 50% of participants complete the survey. Other goals are to determine how many eligible patients agree to participate and how acceptable the intervention is to patients and oncology clinicians. The study will also explore changes in participants' unmet needs and describe how the navigation program is delivered, including navigator activities, participant engagement, and other factors that may affect implementation.

Conditions

Malignancies Multiple; Cancer

Keywords

systemic cancer treatment; treatment; young adult; electronic health record

Outcome Measures

Primary Outcomes (1)

• Feasibility of the AYA-PARTNER Intervention

  The proportion of patients who consent to participate and maintain contact through the 4-month intervention by completing the 4-month survey.

  Up to 4 months

Secondary Outcomes (3)

• Participant Enrollment Rate

  Up to 4 months

• Acceptability of the AYA-PARTNER Intervention

  Up to 4 months

• Provider Acceptability of the AYA-PARTNER Intervention

  Up to 4 months

Study Arms (1)

AYA-PARTNER

EXPERIMENTAL

Young adults between 18 and 39 years of age who are currently receiving systemic anti-cancer therapy or are expected to begin systemic anti-cancer therapy within a month.

Behavioral: AYA-PARTNER Navigation Intervention

Interventions

AYA-PARTNER Navigation Intervention BEHAVIORAL

Participants will receive personalized support and navigation from a trained study navigator for 4 months, with contact at least once each month through phone, text message, email, MyChart, or video based on their preference.

AYA-PARTNER

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
• Age 18-39 years at the time of consent.
• Histological or cytological evidence/confirmation of any invasive cancer.
• Currently receiving any form of systemic anti-cancer therapy

You may not qualify if:

• Patients only receiving surgery or radiation therapy (not systemic therapy)
• Unable to communicate in English.
• Patients do not have access to both phone and internet.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Teen Cancer America, Inc.: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jacob Stein, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah C Winslow

CONTACT

919-984-0000; Hannah_Winslow@med.unc.edu

Allison Bell

CONTACT

allison_bell@med.unc.edu

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

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)