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临床试验/NCT02442323
NCT02442323已完成不适用

A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients

Fox Chase Cancer Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Patient-reported outcome of quality of life

研究概览

简要总结

Despite evidence regarding the benefits of physical activity in various cancer patient populations, the effects of a home-based walking program for pancreatic cancer patients have been under-explored. The aims of the proposed pilot project are to: (1) Assess the feasibility of implementing a 12-week, home-based walking program among pancreatic cancer patients; and (2) Examine the effects of a 12-week, home-based walking program on quality of life (QOL) and symptoms among pancreatic cancer patients.

详细描述

Among cancer patients, physical activity interventions can lead to improvements in QOL and reductions in fatigue and pain. While pancreatic cancer patients may have physical restrictions that limit their participation in moderate to high-intensity exercise activities, empirical evidence suggests that even low-intensity, home-based walking programs can confer benefits for cancer patients. In this pilot study, 50 patients will be randomly assigned to receive either the walking intervention program or usual care (UC). Assessments of quality of life, distress, and symptom burden will be completed at baseline (pre-intervention) and at follow-up (i.e. within 2 weeks post-intervention or approximately 12-14 weeks post-baseline). Data from the proposed pilot study will inform the development of a larger randomized trial designed to improve QOL and reduce morbidity in this patient population.

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

入选标准

  • Patients aged 18 years or older
  • Have histologically confirmed adenocarcinoma of the pancreas (including adenocarcinoma subtypes such as signet ring carcinoma, adenosquamous carcinoma, undifferentiated/poorly differentiated carcinoma, and mucinous carcinoma)
  • Have an estimated life expectancy of greater than 3 months
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Are undergoing treatment for pancreatic cancer at Fox Chase Cancer Center
  • Have borderline resectable or unresectable locally advanced disease or metastatic disease

排除标准

  • Patients with islet cell/neuroendocrine or papillary cystic neoplasm
  • Patients scheduled to undergo surgical resection for curative intent during study participation
  • Patients receiving 3rd-line palliative chemotherapy
  • Inability to communicate in English.

结局指标

主要结局

Patient-reported outcome of quality of life

时间窗: 14 weeks post-baseline

Quality of life will be measured using the FACT-Hep, a validated tool that assesses 4 components of quality of life (physical well-being, emotional well-being, social well-being, and functional well-being), as well as common symptoms associated with hepatobiliary cancers, including pancreatic cancer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Fang, PhD

Principal Investigator

Fox Chase Cancer Center

研究点 (2)

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