Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Cancer-related Fatigue Severity Using The Brief Fatigue Inventory.
研究概览
简要总结
Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.
详细描述
Persons with non-small cell lung cancer (NSCLC) report significantly more unmet supportive care needs than other cancer populations, yet they are among the most vulnerable and least studied. Two of the most prevalent unmet supportive care needs include overcoming fatigue and attaining adequate exercise to meet physical demands of daily living. Cancer-related fatigue (CRF) is a prevalent, persistent, and distressing symptom in the NSCLC population. Cancer-related fatigue correlates with greater severity of 15 other symptoms, leading to lower physical function for persons with NSCLC. Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. While surgery is the standard curative treatment for NSCLC, no formal guidelines exist for post-surgical rehabilitation. This is a proposed randomized controlled trial (RCT) of a novel rehabilitative intervention for persons with NSCLC after surgery. The intervention promotes self-management of CRF and tests the intervention's impact on CRF severity and fatigability with analysis by age. A previous study incorporating the proposed intervention exceeded goals for recruitment, retention, adherence, acceptability, and preliminary efficacy, with no adverse events reported. The investigator's long-term goal is to develop interventions to increase perceived self-efficacy for CRF self-management in order to improve CRF, symptom status, functional status, and quality of life (QOL) for persons with NSCLC. The objective in this application is to determine the efficacy, optimal timing, and sustainability of this innovative home-based exercise intervention. This study has the potential to transform the current standard by providing a rehabilitative exercise intervention after surgery. The intervention is home-based, self-paced, and builds in duration upon discharge from the hospital after surgery. Aim 1: Determine efficacy by comparing the immediate intervention group with wait-list control (usual care) and attention control by age. Aim 2: Determine efficacy of initiating the exercise intervention 6 wks post-discharge and compare results with the immediate intervention group for all ages. Aim 3: Determine the immediate intervention's sustainability by analyzing 3a) rates of extension, adherence, and retention; 3b) acceptability; and 3c) efficacy of primary and secondary outcomes. IMPACT: The results of this study will provide a novel exercise intervention, and its optimal timing, and fill the gap for a vulnerable population by providing a practical, portable, and low-cost means of reducing CRF severity and fatigability that is enjoyable and applicable to nearly all post-thoracotomy lung cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Women and men
- •At least 18 years of age (Michigan) and 19 years of age in (Nebraska)
- •With suspected non-small cell lung cancer to be confirmed after surgery
- •Karnofsky Performance Status score of at least 70%
- •Thoracic surgeon approval pre- and post-surgery
- •Medically stable comorbid conditions allowing for non-small cell lung cancer surgery clearance
- •Has phone access capability
- •Able to speak and write English
- •Able to hear and speak for phone interviews
- •Owns a television
- •Lives within 2 hours driving distance of recruitment site
排除标准
- •Severe impairment of sight, hearing, speaking
- •Active treatment for malignancy within past 3 months (other than non-melanoma skin cancer or long-term hormonal treatment for common cancers such as breast and prostate if disease is stable
- •Weight greater than 330 pounds
- •History of photosensitive seizures
- •Any condition or disorder that would impede safe participation as directed
- •Plans to relocate outside the area during the study period or unable to fully participate
研究组 & 干预措施
Light Physical Activity 1
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.
干预措施: Light Physical Activity 1 (Behavioral)
Light Physical Activity 2
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.
干预措施: Light Physical Activity 2 (Behavioral)
Support Education Activity
Conventional treatment for cancer as prescribed by the participant's health care providers and will participate in a supportive cancer-related education activity each week for 6-weeks after returning home from the hospital.
干预措施: Support Education Activity (Behavioral)
结局指标
主要结局
Cancer-related Fatigue Severity Using The Brief Fatigue Inventory.
时间窗: about 6 weeks after discharge from the hospital
The Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)
Cancer-Related Fatigue Fatigability as Assessed Using the 6 Minute Walk Test.
时间窗: Immediately after discharge from the hospital
This is a times and measured test to determine the number of meters a participant can walk in 6 minutes. Lower values indicate greater fatigability.
次要结局
- Perceived Self-Efficacy for Fatigue Self-Management(about 6 weeks after discharge from the hospital)
- Other Symptoms Severity(about 6 weeks after discharge from the hospital)
- Self-Efficacy for Walking Duration(about 6 weeks after discharge from the hospital)
- Activities-Specific Balance Confidence(about 6 weeks after discharge from the hospital)
- Steps Per Day(about 6 weeks after discharge from the hospital)
- Functional Status Performance(about 6 weeks after discharge from the hospital)
- Quality of Life as Assessed Using the Quality of Life Index(about 6 weeks after discharge from the hospital)