The STRONG Nutrition Support Study for People With Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: STRONG intervention App (Other)
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.
干预措施: individualized remote dietitian (Other)
结局指标
主要结局
Recruitment Rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Changes in Nutritional Status(Baseline and up to 6 months)
- Changes in General Health-related Quality of Life(Baseline and up to 6 months)
- Appetite/Cachexia-Related Quality of Life(Baseline, up to 6 months)
- Hepatobiliary/Pancreatic Cancer-Related Quality of Life(Baseline, up to 6 months)
- Healthcare Utilization(Up to 6 months)
- Treatment Delivery(Up to 6 months)
- Survival Outcomes(Up to 6 months)