The STRONG Nutrition Support Study for People With Pancreatic Cancer (STRONG)
2026年9月14日 更新者：UNC Lineberger Comprehensive Cancer Center
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.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Emma C Hume
- 电话号码：9199664260
- 邮箱：Emma.Hume@unc.edu
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
-
首席研究员：
- Kea Turner, PhD, MPH, MA
-
接触：
- Emma C Hume
- 电话号码：919-966-4260
- 邮箱：Emma.Hume@unc.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Patients Participants
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG
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.
|
STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
|
|
有源比较器：Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials
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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment Rate
大体时间：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
|
Baseline
|
|
Retention Rate
大体时间：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
|
Baseline
|
|
Study Assessment Completion
大体时间：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
|
Up to 6 months
|
|
Remote Nutrition Counseling Completion
大体时间：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
|
Up to 6 months
|
|
STRONG Engagement
大体时间：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
|
Up to 6 months
|
|
Food and Symptom Diary Completion
大体时间：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 |
Up to 6 months
|
|
Intervention Fidelity
大体时间：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 |
Up to 6 months
|
|
Reasons for Non-Participation or Attrition
大体时间：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.
|
Up to 6 months
|
|
Overall Satisfaction with STRONG
大体时间：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
|
Up to 6 months
|
|
Satisfaction with Intervention Components
大体时间：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 |
Up to 6 months
|
|
Perceived Benefit
大体时间：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 |
Up to 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Nutritional Status
大体时间：Baseline and up to 6 months
|
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.
|
Baseline and up to 6 months
|
|
Changes in General Health-related Quality of Life
大体时间：Baseline and up to 6 months
|
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. |
Baseline and up to 6 months
|
|
Appetite/Cachexia-Related Quality of Life
大体时间：Baseline, up to 6 months
|
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.
|
Baseline, up to 6 months
|
|
Hepatobiliary/Pancreatic Cancer-Related Quality of Life
大体时间：Baseline, up to 6 months
|
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.
|
Baseline, up to 6 months
|
|
Healthcare Utilization
大体时间：Up to 6 months
|
Healthcare Utilization: Number of emergency department visits during the study period, assessed by participant self-report and/or medical record abstraction, when available.
|
Up to 6 months
|
|
Treatment Delivery
大体时间：Up to 6 months
|
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.
|
Up to 6 months
|
|
Survival Outcomes
大体时间：Up to 6 months
|
Overall survival and progression-free survival, assessed using cancer registry data and/or medical record abstraction.
|
Up to 6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.
大体时间：Up to 6 months
|
Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.
The outcome will be the change in ZBI score from baseline to 3 months and from baseline to 6 months.
The Zarit Burden Interview (ZBI) 12-item Short Form is a self-report measure of caregiver burden.
It assesses how caregiving affects the caregiver's emotional, social, physical, and financial well-being.
The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
|
Up to 6 months
|
|
Change in caregiver quality of life
大体时间：Baseline, up to 6 months
|
Caregiver quality of life will be assessed using the Caregiver Quality of Life Index-Cancer (CQOLC), a self-report instrument designed to assess the quality of life of individuals providing care to patients with cancer.
The CQOLC evaluates multiple domains of caregiver quality of life, including emotional distress, burden, positive adaptation, and disruption of daily activities.
The total score ranges from 0-140, with higher scores indicating better caregiver quality of life[M.
|
Baseline, up to 6 months
|
|
Change in caregiver distress
大体时间：Baseline, up to 6 months
|
Caregiver distress will be assessed using the caregiver-specific version of the National Comprehensive Cancer Network (NCCN) Distress Thermometer.
The Distress Thermometer is a self-report measure of overall distress rated on a 0-to-10 scale, with 0 indicating no distress and 10 indicating extreme distress.
The caregiver-specific version includes additional problem areas relevant to caregiving, such as assisting with symptom management and providing emotional support.
Higher scores indicates greater distress.
|
Baseline, up to 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kea Turner, PhD, MPH, MA、UNC Lineberger Comprehensive Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年8月1日
研究完成 (估计的)
2029年8月1日
研究注册日期
首次提交
2026年9月8日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- STRONG
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Researchers may request de-identified data 1 year after publication.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.