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临床试验/NCT01982994
NCT01982994已完成不适用

Intervention to Motivate Standing &Walking in Gastrointestinal Cancer Surgical Patients

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Percentage of patients with diagnosed gastrointestinal cancer who showed daily compliance using activity monitors and tablet computers to measure physical activity.

研究概览

简要总结

Observational research has linked physical activity with faster recovery, improved quality of life, and greater survival; however, little is known about the effects of physical activity in pre-operative, peri-operative, or post-operative treatment contexts and there is a need for interventions to improve patient outcomes across the cancer treatment continuum. Three propositions derived from basic research, epidemiological evidence, and clinical practice informed our intervention development efforts: (1) Patient outcomes will be enhanced by interventions that increase physical activity (i.e., standing, walking) across the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure) will enhance patient outcomes both by increasing physical activity and by stimulating additional adaptive physiological responses to reduced sedentary time (responses which are independent of physical activity-induced responses). (3) Patients with gastrointestinal cancers often suffer functional limitations that limit their independence and their health behaviors are strongly influenced by the family environment so interventions that engage caregivers (e.g., spouses) will be more effective than those that target patients/survivors alone.

详细描述

Phase 1 Screening and Baseline Assessment in Clinic Patients will be recruited by their physician upon diagnosis and immediately after the Penn State Surgical Oncology team presents then with the surgical treatment option. The patient must be able to identify an adult caregiver. The caregiver must be someone who is willing to participate in the study for the intervention period.

Once enrolled by the research assistant, the participant will complete an intake questionnaire to capture demographic information. The participant will then be given a tablet computer, training on how to use it to complete the questionnaires at the beginning and end of each day, an activity monitor with materials for securing it, and training on how/where to affix it on the leg.

In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase). Although intentions are necessary for behavior change, a recent review of experimental evidence indicates that they are not sufficient. In the volitional phase, people translate those intentions into action by developing actions plans that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk around my neighborhood) and coping plans that specify how they will overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have already developed an electronic daily planning tool that can be used at the beginning of each day to form action and coping plans for the target behaviors in this intervention. In the first two months of this project, we will tailor this existing planning tool for the target population by drawing from existing and emerging research on strategies for and barriers to health behaviors among cancer patients.

The control group will not receive the educational or daily planning components of the motivational intervention. They will, however, engage in self-monitoring by virtue of wearing activity monitors and using tablet computers to provide self-report data on their physical activity and sedentary behavior.

After the patient's surgery while staying at the Penn State Hershey Medical Center, the study coordinator will provide the caregiver with behavioral goals to help the patient recover from his/her surgery, and additional information about how the caregiver can support the patient's behavior change efforts.

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
Triple (Participant, Care Provider, Investigator)

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

  • •Diagnosis of gastrointestinal tract cancer (hepatobiliary) requiring surgical resection. for treatment
  • •Failing to meet the aerobic component of national physical activity guidelines over past week (e.g., < 150 min moderate-intensity physical activity or < 75 min vigorous-intensity physical activity).
  • •Excessive sedentary behavior over the past week (> 8 hrs/day sitting).
  • •Minimum age 18 years.
  • •A spouse or adult child serving as a caregiver who is also willing to participate.

排除标准

  • •Functional limitations that preclude normal physical activity.
  • •Patients who will be scheduled for surgery < 10 days after their clinic visit.
  • •Medical contraindications to physical activity.

研究组 & 干预措施

No Education/Daily Planning

No Intervention

No Physical Activity Education/ Daily Planning Tool

Education/Daily Planning

Experimental

Physical Activity Education and Daily Planning Tool

干预措施: Education/Daily Planning (Behavioral)

结局指标

主要结局

Percentage of patients with diagnosed gastrointestinal cancer who showed daily compliance using activity monitors and tablet computers to measure physical activity.

时间窗: up to 1 year

To demonstrate the feasibility and acceptability of using activity monitors and tablet computers to measure physical activity (standing, walking)/sedentary behavior (sitting) and deliver daily interventions in this patient population, we will evaluate daily compliance using activity monitors and tablet computers.

次要结局

  • Percentage of patients with a diagnosis of gastrointestinal cancer that benefit from an intervention of physical activity daily planning and education.(up to 1 year)

研究者

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

Niraj J. Gusani MD

Professor of Surgery and Public Health Sciences

Milton S. Hershey Medical Center

研究点 (1)

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