CancerAYA-PARTNERNCT07829146
Feasibility Pilot of AYA-PARTNER
A study testing AYA-PARTNER Navigation Intervention in people with Cancer and Malignancies Multiple, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Malignancies Multiple
- What is being tested?
- AYA-PARTNER Navigation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Allison Bell contact
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Hannah C Winslow, 919-984-0000, Hannah_Winslow@med.unc.edu
Jake Stein, MD
About this study
Official title: 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
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.
Read more
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
- Being tested
- AYA-PARTNER Navigation Intervention
- Keywords
- systemic cancer treatment, treatment, young adult, electronic health record
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYA-PARTNER Navigation InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AYA-PARTNER Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 months
Secondary outcomes (3)
Participant Enrollment Rate
The proportion of eligible patients who consent to participate in the intervention after eligibility is confirmed.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Teen Cancer America, Inc.
- Responsible party
- Sponsor
- Investigators
- Jacob Stein, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829146
- Sponsor's protocol ID
- LCCC2618
- Acronym
- AYA-PARTNER
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07829146
- Acronym / sponsor ID
- AYA-PARTNER / LCCC2618
- Conditions
- Cancer, Malignancies Multiple
- Keywords
- systemic cancer treatment, treatment, young adult, electronic health record
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Teen Cancer America, Inc.
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AYA-PARTNER | Experimental | Behavioral: AYA-PARTNER Navigation InterventionYoung 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AYA-PARTNER Navigation InterventionParticipants 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. | Behavioural | AYA-PARTNER |
Primary outcome
Feasibility of the AYA-PARTNER Intervention
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.
3 secondary outcomes
Participant Enrollment Rate
Time frame: Up to 4 months
Acceptability of the AYA-PARTNER Intervention
Time frame: Up to 4 months
Provider Acceptability of the AYA-PARTNER Intervention
Time frame: Up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Bell contact
Jacob Stein, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYA-PARTNER Navigation Intervention in people with Cancer and Malignancies Multiple, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah C Winslow (919-984-0000, Hannah_Winslow@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the AYA-PARTNER Intervention (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.