Feasibility Pilot of AYA-PARTNER

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: AYA-PARTNERExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 4 months

Secondary outcomes

1

Participant Enrollment Rate

The proportion of eligible patients who consent to participate in the intervention after eligibility is confirmed.

Time frame
Up to 4 months
2

Acceptability of the AYA-PARTNER Intervention

Acceptability of the intervention will be measured at month 4 using an adapted 8-item Theoretical Framework of Acceptability (TFA) survey. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability.

Time frame
Up to 4 months
3

Provider Acceptability of the AYA-PARTNER Intervention

Acceptability of the AYA-PARTNER intervention among oncology providers will be assessed at the end of the study using a provider version of the adapted 8-item Theoretical Framework of Acceptability (TFA) survey. The survey will assess providers' perceptions of the intervention, including its appropriateness, ease of use, burden, and fit within routine clinical care. Items will be rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability.

Time frame
Up to 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

Teen Cancer America, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: