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临床试验/NCT05438927
NCT05438927进行中(未招募)不适用

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Participant Rating on Ease of Use for the Mobile Application - Usability

研究概览

简要总结

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • ≥18 years old
  • Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
  • Planning to initiate chemotherapy under the guidance of Moffitt
  • Able to speak and read English or Spanish
  • Able to provide informed consent

排除标准

  • Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
  • Undergoing concurrent treatment for a second primary GI cancer
  • ECOG status of 2 or greater
  • Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer
  • Use of parenteral or enteral nutrition
  • Presence of malignant ascites
  • The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.

结局指标

主要结局

Participant Rating on Ease of Use for the Mobile Application - Usability

时间窗: 12 Months

The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake

Data Collection - Feasibility

时间窗: 12 Months

The study will be deemed feasible if ≥ 50% of participants submit study assessments

Recruitment Rate - Feasibility

时间窗: 12 Months

The study will be deemed feasible if ≥ 50% of eligible participants are recruited

次要结局

  • Participant Compliance with Dietary Log - Intervention Adherence(12 Months)
  • Participant Compliance with Palliative Care Visits - Intervention Adherence(12 Months)
  • Participant Compliance with Dietician Visits - Intervention Adherence(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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