Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Self-report of physical activity behavior (duration, intensity and frequency)
研究概览
简要总结
Generally, patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Regular physical activity improves emotional well-being, increases immunological response, improves wound healing, lessens fatigue and improves general functionality and quality of life.
This study will determine effectiveness of the 12-week exercise intervention program, determine if physically active patients differ in quality of life, depression and fatigue during the course of the study, and determine if the change in physical activity levels is related to changes in immune responses.
详细描述
The general hypothesis of this research is that patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Increasing and sustaining physical activity of these patients will improve their emotional well-beings, increase their immunological response, improve wound healing, lessen fatigue and improve their general functionality and quality of life.
The purposes of this study are to: (1) determine the effectiveness of the 12-week exercise intervention program in increasing physical activity in head and neck cancer patients; (2) determine if physically active patients differ in quality of life, depression and fatigue during the course of the study; and (3) determine if the change in physical activity levels is related to changes in the immune responses in human.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years of age or above (Nebraska legal age).
- •Patients diagnosed with HNC who are seen at the University of Nebraska Medical Center.
- •Patients who have undergone chemotherapy, radiation and/or surgery for their cancer.
- •Patients who have completed their cancer treatment at least 3 months prior.
- •Patients who have consented to participate in this study with approval by their physicians.
- •Patients who have no significant mental impairment.
排除标准
- •Patients who are on enteral feeding.
- •Patients who are not able to walk or whose surgeons report that walking is not advisable.
- •Patients diagnosed with Lymphoma, Thyroid cancer or Melanoma.
- •Patients who are on antidepressant medications.
- •Patients who are unwilling to return to the clinic at the end of the study - after 12 weeks of intervention.
- •Patients participating in another research study involving a therapeutic intervention.
- •Patients with chronic medical and orthopedic conditions that would preclude physical activity (e.g., congestive heart failure, recent knee or hip replacements).
- •Patients who are at 18 months or more after the start of cancer treatment.
结局指标
主要结局
Self-report of physical activity behavior (duration, intensity and frequency)
时间窗: Baseline and Post Intervention
Participants will be taught how to keep the Activity diary to record walking and physical activities.
次要结局
- Plasma IL-6 Concentration(Baseline and Post Intervention)