Pancreas Cancer, MetastaticSTRONGNCT07826780
The STRONG Nutrition Support Study for People With Pancreatic Cancer
A study testing STRONG intervention App and individualized remote dietitian in people with Pancreas Cancer, Metastatic and Pancreas Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This single-center pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of STRONG, a digital nutrition support app delivered alongside remote dietitian-led nutrition counseling, in adults with pancreatic ductal adenocarcinoma initiating systemic therapy and/or radiation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer, Metastatic, Pancreas Carcinoma
- What is being tested?
- STRONG intervention App and individualized remote dietitian
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2029
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Diagnosis of pancreatic ductal adenocarcinoma
- Has initiated or scheduled to initiate systemic therapy and/or radiation therapy within 30 days of study enrollment
- Able to speak and read English
Show all 11Show fewer
- Age ≥18 years at the time of consent.
- Identified by an enrolled patient participant as their primary caregiver or support person.
- Able to speak and read English
- Able to provide informed consent.
- Willing and able to complete caregiver study procedures, including baseline and follow-up questionnaires and, if selected and interested, an optional exit interview.
Who cannot join
- Enrolled in hospice care or has a plan for hospice enrollment at the time of study enrollment
- Not community dwelling at the time of study enrollment, including individuals who are incarcerated, residing in a skilled nursing facility, long-term care facility, or other institutional setting where meals, nutrition management, or access to study procedures are primarily controlled by the institution
- Unable to consume food or beverages orally at the time of consent, including individuals who are fully dependent on total parenteral nutrition or who have complete malignant bowel obstruction or severe gastric outlet obstruction that prevents meaningful oral intake or makes oral nutrition unsafe.
- Any condition or circumstance that, in the judgment of the investigator or designee, such as a patient's oncologist, would make study participation inappropriate or would interfere with the participant's ability to complete study procedures, such as advanced dementia or other severe cognitive impairment.
- Caregiver Participants
- Any condition or circumstance that, in the judgment of the investigator or designee, would make participation inappropriate or would interfere with completion of study procedures, such as advanced dementia or other severe cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
Emma C Hume, 919-966-4260, Emma.Hume@unc.edu
Kea Turner, PhD, MPH, MA
About this study
This single-center pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of STRONG, a digital nutrition support app delivered alongside remote dietitian-led nutrition counseling, in adults with pancreatic ductal adenocarcinoma initiating systemic therapy and/or radiation therapy. Approximately 80 participants will be randomized 1:1 to receive nutrition counseling plus either the STRONG app or printed nutrition education materials. Outcomes include feasibility, acceptability, nutritional status, quality of life, healthcare utilization, treatment delivery, caregiver outcomes, and survival. Findings will inform the design of a future trial evaluating whether app-based, tailored nutrition support improves outcomes compared with traditional nutrition education.
- Conditions
- Pancreas Cancer, Metastatic, Pancreas Carcinoma
- Being tested
- STRONG intervention App, individualized remote dietitian
- Keywords
- diet, chemotherapy, systemic therapy, radiotherapy, nutrition app
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRONG intervention AppOther
STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
individualized remote dietitianOther
individualized remote dietitian visits consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG | Experimental | Participants randomized to the STRONG arm will receive individualized nutrition counseling delivered remotely by a registered dietitian, in addition to access to the STRONG intervention. The intervention will be delivered over approximately 3 months and will include one initial remote dietitian visit and two remote follow-up visits. Participants will use the STRONG app to support nutrition-related education, self-management, and engagement between counseling visits. Receives: Other: STRONG intervention App |
| Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials | Active comparator | Participants randomized to the comparison arm will receive the same schedule of individualized remote dietitian-led nutrition counseling as participants in the STRONG arm, consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period. Receives: Other: individualized remote dietitian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible patient participants who provide informed consent and enroll in the study. The feasibility benchmark is ≥50%. Recruitment Rate (%) = (Number of eligible patients who consent and enroll ÷ Number of eligible patients approached) × 100
Measured: Baseline
Retention Rate
Proportion of enrolled patient participants who remain in the study through completion of the 3-month intervention period. The feasibility benchmark is ≥85%. Retention Rate (%) = (Number of enrolled participants who complete the 3-month intervention period ÷ Total number of enrolled participants) × 100
Measured: Baseline
Study Assessment Completion
The proportion of enrolled participants who complete at least 2 of the 3 scheduled study assessments during the study period. Assessment Completion Rate (%) = (Number of enrolled participants who complete ≥2 of 3 assessments ÷ Total number of enrolled participants) × 100
Measured: Up to 6 months
Remote Nutrition Counseling Completion
Proportion of randomized patient participants who complete at least 2 of the 3 planned remote dietitian counseling visits during the 3-month intervention period. The feasibility benchmark is ≥70%. Counseling Completion Rate (%) = (Number of randomized participants who complete ≥2 of 3 counseling visits ÷ Total number of randomized participants) × 100
Measured: Up to 6 months
STRONG Engagement
The proportion of STRONG-arm participants who demonstrate sustained engagement with the STRONG intervention by accessing STRONG at least once per week during at least 6 of the 12 intervention weeks. STRONG Engagement Rate (%) = (Number of STRONG-arm participants who access STRONG ≥1 time/week during ≥6 of 12 intervention weeks ÷ Total number of STRONG-arm participants) × 100
Measured: Up to 6 months
Food and Symptom Diary Completion
Among STRONG-arm patient participants, the proportion who complete the food and symptom diary on at least 2 of the 3 days preceding each of the three planned dietitian counseling visits. The feasibility benchmark is ≥70%.
Diary Completion Rate (%) = (Number of STRONG-arm participants who complete the diary on ≥2 of 3 days before all 3 counseling visits ÷ Total number of STRONG-arm participants) × 100
Measured: Up to 6 months
Intervention Fidelity
Proportion of completed dietitian counseling visits in which all required counseling elements outlined in the study counseling checklist were documented as delivered. The fidelity benchmark is ≥80%.
Intervention Fidelity (%) = (Number of completed counseling visits with documentation that all required checklist elements were delivered ÷ Total number of completed counseling visits) × 100
Measured: Up to 6 months
Reasons for Non-Participation or Attrition
Reasons for declining participation, inability to enroll, withdrawal, missed counseling visits, incomplete diary use, or incomplete study assessments will be documented and summarized descriptively when available.
Measured: Up to 6 months
Overall Satisfaction with STRONG
Proportion of STRONG-arm patient participants who complete the 3-month survey and report satisfaction with STRONG. The acceptability benchmark is ≥80%. Satisfaction Rate (%) = (Number of STRONG-arm participants who complete the 3-month survey and report satisfaction with STRONG ÷ Number of STRONG-arm participants who complete the 3-month survey) × 100
Measured: Up to 6 months
Satisfaction with Intervention Components
Among STRONG-arm patient participants, the proportion who report satisfaction with each of the three intervention components: remote nutrition counseling, STRONG, and the food and symptom diary.
Component Satisfaction Rate (%) = (Number of STRONG-arm participants who report satisfaction with the component ÷ Number of STRONG-arm participants who complete the relevant satisfaction item) × 100
Measured: Up to 6 months
Perceived Benefit
Proportion of STRONG-arm patient participants who report that STRONG was beneficial or helpful for managing nutrition concerns during pancreatic cancer treatment.
Perceived Benefit Rate (%) = (Number of STRONG-arm participants who report that STRONG was beneficial or helpful ÷ Number of STRONG-arm participants who complete the relevant survey item) × 100
Measured: Up to 6 months
Secondary outcomes (7)
Changes in Nutritional Status
The Patient-Generated Subjective Global Assessment (PG-SGA) Short Form is a nutrition screening tool that assesses recent weight change, food intake, nutrition-impact symptoms, and functional status. Scores range from 0 to 36, with higher scores indicating greater nutritional risk and need for intervention: 0-1 suggests no immediate intervention, 2-3 indicates possible need for patient education or symptom management, 4-8 indicates a need for intervention by a dietitian or nutrition professional, and ≥9 indicates a critical need for nutrition intervention and/or symptom management.
Measured: Baseline and up to 6 months
Changes in General Health-related Quality of Life
General health-related quality of life was assessed using Change in Functional Assessment of Cancer Therapy-General (FACT-G) score.
The Functional Assessment of Cancer Therapy-General (FACT-G) is a validated 27-item questionnaire used to assess health-related quality of life (HRQoL) in people with cancer. It evaluates four domains: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), and Functional Well-Being (0-28), giving a total score ranging from 0 to 108. Each item is rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Very much"). Higher FACT-G scores indicate better quality of life, while lower scores indicate greater impairment or burden.
Measured: Baseline and up to 6 months
Appetite/Cachexia-Related Quality of Life
Change in Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscale score from baseline to 3 months and from baseline to 6 months. The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) is a patient-reported measure designed to assess quality of life and symptoms associated with cancer-related anorexia/cachexia. It combines the FACT-G questionnaire with an additional 12-item Anorexia/Cachexia Subscale (A/CS), for a total of 39 items. Each item is scored from 0 ("Not at all") to 4 ("Very much"), with negatively worded items reverse-scored. The FAACT total score ranges from 0-156, and higher scores generally indicate better quality of life and fewer anorexia/cachexia-related concerns. Changes in FAACT scores over time can therefore be used to evaluate whether a patient's symptoms and overall quality of life have improved or worsened.
Measured: Baseline, up to 6 months
Hepatobiliary/Pancreatic Cancer-Related Quality of Life
Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score from baseline to 3 months and from baseline to 6 months. The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is a 44-item patient-reported questionnaire assessing health-related quality of life in patients with hepatobiliary cancer. It combines the 27-item FACT-G with a 17-item Hepatobiliary Cancer Subscale (HCS). Each item is scored from 0 ("Not at all") to 4 ("Very much"), with negatively worded items reverse-scored. The total FACT-Hep score ranges from 0 to 176, with higher scores indicating better quality of life and lower scores indicating greater symptom burden or impairment.
Measured: Baseline, up to 6 months
Healthcare Utilization
Healthcare Utilization: Number of emergency department visits during the study period, assessed by participant self-report and/or medical record abstraction, when available.
Measured: Up to 6 months
Treatment Delivery
Treatment Delivery will be defined based on records related to treatment delay, dose reduction, and treatment discontinuation during the study period, assessed by medical record abstraction.
Measured: Up to 6 months
Survival Outcomes
Overall survival and progression-free survival, assessed using cancer registry data and/or medical record abstraction.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas Cancer, MetastaticStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kea Turner, PhD, MPH, MA, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826780
- Sponsor's protocol ID
- STRONG
- Acronym
- STRONG
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers may request de-identified data 1 year after publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STRONG Nutrition Support Study for People With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07826780
- Acronym / sponsor ID
- STRONG / STRONG
- Conditions
- Pancreas Cancer, Metastatic, Pancreas Carcinoma
- Keywords
- diet, chemotherapy, systemic therapy, radiotherapy, nutrition app
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 17 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 single-center pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of STRONG, a digital nutrition support app delivered alongside remote dietitian-led nutrition counseling, in adults with pancreatic ductal adenocarcinoma initiating systemic therapy and/or radiation therapy. Approximately 80 participants will be randomized 1:1 to receive nutrition counseling plus either the STRONG app or printed nutrition education materials. Outcomes include feasibility, acceptability, nutritional status, quality of life, healthcare utilization, treatment delivery, caregiver outcomes, and survival. Findings will inform the design of a future trial evaluating whether app-based, tailored nutrition support improves outcomes compared with traditional nutrition education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG | Experimental | Other: STRONG intervention AppParticipants randomized to the STRONG arm will receive individualized nutrition counseling delivered remotely by a registered dietitian, in addition to access to the STRONG intervention. The intervention will be delivered over approximately 3 months and will include one initial remote dietitian visit and two remote follow-up visits. Participants will use the STRONG app to support nutrition-related education, self-management, and engagement between counseling visits. |
| Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials | Active comparator | Other: individualized remote dietitianParticipants randomized to the comparison arm will receive the same schedule of individualized remote dietitian-led nutrition counseling as participants in the STRONG arm, consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Diagnosis of pancreatic ductal adenocarcinoma
- Has initiated or scheduled to initiate systemic therapy and/or radiation therapy within 30 days of study enrollment
Key exclusion criteria (6 listed)
- Enrolled in hospice care or has a plan for hospice enrollment at the time of study enrollment
- Not community dwelling at the time of study enrollment, including individuals who are incarcerated, residing in a skilled nursing facility, long-term care facility, or other institutional setting where meals, nutrition management, or access to study procedures are primarily controlled by the institution
- Unable to consume food or beverages orally at the time of consent, including individuals who are fully dependent on total parenteral nutrition or who have complete malignant bowel obstruction or severe gastric outlet obstruction that prevents meaningful oral intake or makes oral nutrition unsafe.
- Any condition or circumstance that, in the judgment of the investigator or designee, such as a patient's oncologist, would make study participation inappropriate or would interfere with the participant's ability to complete study procedures, such as advanced dementia or other severe cognitive impairment.
- Caregiver Participants
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 |
|---|---|---|
| STRONG intervention AppSTRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months. | Other | Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG |
| individualized remote dietitianindividualized remote dietitian visits consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period. | Other | Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials |
Primary outcome
Recruitment Rate
Time frame: Baseline
Proportion of eligible patient participants who provide informed consent and enroll in the study. The feasibility benchmark is ≥50%. Recruitment Rate (%) = (Number of eligible patients who consent and enroll ÷ Number of eligible patients approached) × 100
Retention Rate
Time frame: Baseline
Proportion of enrolled patient participants who remain in the study through completion of the 3-month intervention period. The feasibility benchmark is ≥85%. Retention Rate (%) = (Number of enrolled participants who complete the 3-month intervention period ÷ Total number of enrolled participants) × 100
Study Assessment Completion
Time frame: Up to 6 months
The proportion of enrolled participants who complete at least 2 of the 3 scheduled study assessments during the study period. Assessment Completion Rate (%) = (Number of enrolled participants who complete ≥2 of 3 assessments ÷ Total number of enrolled participants) × 100
Remote Nutrition Counseling Completion
Time frame: Up to 6 months
Proportion of randomized patient participants who complete at least 2 of the 3 planned remote dietitian counseling visits during the 3-month intervention period. The feasibility benchmark is ≥70%. Counseling Completion Rate (%) = (Number of randomized participants who complete ≥2 of 3 counseling visits ÷ Total number of randomized participants) × 100
STRONG Engagement
Time frame: Up to 6 months
The proportion of STRONG-arm participants who demonstrate sustained engagement with the STRONG intervention by accessing STRONG at least once per week during at least 6 of the 12 intervention weeks. STRONG Engagement Rate (%) = (Number of STRONG-arm participants who access STRONG ≥1 time/week during ≥6 of 12 intervention weeks ÷ Total number of STRONG-arm participants) × 100
Food and Symptom Diary Completion
Time frame: Up to 6 months
Among STRONG-arm patient participants, the proportion who complete the food and symptom diary on at least 2 of the 3 days preceding each of the three planned dietitian counseling visits. The feasibility benchmark is ≥70%. Diary Completion Rate (%) = (Number of STRONG-arm participants who complete the diary on ≥2 of 3 days before all 3 counseling visits ÷ Total number of STRONG-arm participants) × 100
Intervention Fidelity
Time frame: Up to 6 months
Proportion of completed dietitian counseling visits in which all required counseling elements outlined in the study counseling checklist were documented as delivered. The fidelity benchmark is ≥80%. Intervention Fidelity (%) = (Number of completed counseling visits with documentation that all required checklist elements were delivered ÷ Total number of completed counseling visits) × 100
Reasons for Non-Participation or Attrition
Time frame: Up to 6 months
Reasons for declining participation, inability to enroll, withdrawal, missed counseling visits, incomplete diary use, or incomplete study assessments will be documented and summarized descriptively when available.
Overall Satisfaction with STRONG
Time frame: Up to 6 months
Proportion of STRONG-arm patient participants who complete the 3-month survey and report satisfaction with STRONG. The acceptability benchmark is ≥80%. Satisfaction Rate (%) = (Number of STRONG-arm participants who complete the 3-month survey and report satisfaction with STRONG ÷ Number of STRONG-arm participants who complete the 3-month survey) × 100
Satisfaction with Intervention Components
Time frame: Up to 6 months
Among STRONG-arm patient participants, the proportion who report satisfaction with each of the three intervention components: remote nutrition counseling, STRONG, and the food and symptom diary. Component Satisfaction Rate (%) = (Number of STRONG-arm participants who report satisfaction with the component ÷ Number of STRONG-arm participants who complete the relevant satisfaction item) × 100
Perceived Benefit
Time frame: Up to 6 months
Proportion of STRONG-arm patient participants who report that STRONG was beneficial or helpful for managing nutrition concerns during pancreatic cancer treatment. Perceived Benefit Rate (%) = (Number of STRONG-arm participants who report that STRONG was beneficial or helpful ÷ Number of STRONG-arm participants who complete the relevant survey item) × 100
7 secondary outcomes
Changes in Nutritional Status
Time frame: Baseline and up to 6 months
Changes in General Health-related Quality of Life
Time frame: Baseline and up to 6 months
Appetite/Cachexia-Related Quality of Life
Time frame: Baseline, up to 6 months
Hepatobiliary/Pancreatic Cancer-Related Quality of Life
Time frame: Baseline, up to 6 months
Healthcare Utilization
Time frame: Up to 6 months
Treatment Delivery
Time frame: Up to 6 months
Survival Outcomes
Time frame: Up to 6 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 17 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchers may request de-identified data 1 year after publication.
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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.
Kea Turner, PhD, MPH, MA 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 STRONG intervention App and individualized remote dietitian in people with Pancreas Cancer, Metastatic and Pancreas Carcinoma, 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 11 inclusion and 6 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 17 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 Emma C Hume (9199664260, Emma.Hume@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline). The study lists 11 primary outcomes in all. 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 17 Sep 2026.