University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT07829146
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.
Trial opening soon.
Get Notified18 year–39 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Exclusion criteria
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.
Time frame: Up to 4 months
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
The proportion of eligible patients who consent to participate in the intervention after eligibility is confirmed.
Time frame: Up to 4 months
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
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.
Contact information is provided by the study sponsor or research team.
UNC Lineberger Comprehensive Cancer Center
Other
Feasibility Pilot of the Adapted Adolescent and Young Adult Patient Advocacy, Real-Time Navigation, Equity and Reach (AYA-PARTNER) Intervention To Address Unmet Needs of AYAs Undergoing Active Cancer Treatment
Acronym: AYA-PARTNER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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