Recruiting

AYA-PARTNER

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07829146

Conditions

Cancer

Malignancies Multiple

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

AYA-PARTNER Navigation Intervention

Study Details

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

Cancer

Malignancies Multiple

Study ID

NCT07829146

Start date

Sep 11, 2026

Status verified date

Nov, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: AYA-PARTNER

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.

Interventions

AYA-PARTNER Navigation Intervention

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.

Primary outcome measure

  • Feasibility of the AYA-PARTNER Intervention [ Time Frame: Up to 4 months ]

Central Contacts and Locations

Central contacts

Hannah C Winslow

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

Allison Bell

allison_bell@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Hannah C Winslow

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

Principal Investigator:

Jake Stein, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.