Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2)
研究概览
简要总结
The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes.
详细描述
Among the devastating illnesses impacting rural America, few exact the physical, social, psychological, and economic toll of lung cancer. Lung cancer is the leading cause of cancer death in rural America, and the levy is particularly acute in Kentucky - a state that not only leads the nation in lung cancer incidence and mortality but is a global epicenter of lung cancer. Despite the prevailing nihilism regarding lung cancer care, lung cancer survivors are living longer. Innovations in prevention, early detection, and treatment, have created substantial optimism and opportunities for long-term lung cancer survivorship. These dramatic changes in the lung cancer care landscape have invigorated the need for quality lung cancer survivorship interventions. The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. Using a novel precision survivorship approach and developed in collaboration with rural community stakeholders, the program's foundation incorporates principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement. A large acceptability and feasibility trial conducted in collaboration with nine lung cancer care facilities in Kentucky with lung cancer survivors (N=140) demonstrated the acceptability of the intervention among survivors, caregivers, and lung cancer care clinicians. The study also revealed the feasibility of conducting the proposed study methods in rural cancer care facilities. The project continues this program of research by conducting a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes. Rural-residing lung cancer survivors will be recruited from ten oncology care facilities throughout Kentucky. The project's first aim compares the efficacy of the interventions with regard to lung cancer quality of life among survivors as measured by the FACT-L and other rigorous assessments of patient engagement, symptom burden, psychosocial well-being, and behavior change. The project's second aim evaluates the moderating impact of including caregivers as intervention partners on survivor quality of life outcomes. A third aim evaluates the cost-effectiveness of the KLCLCSC intervention in comparison to the enhanced usual care condition. Based on highly encouraging pilot data collected in collaboration with oncology care programs in Kentucky, this research holds credible potential to establish a new paradigm for addressing the challenges associated with lung cancer and for delivering quality survivorship care to rural-residing, economically distressed lung cancer survivors.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigators and outcomes assessors will be masked to the random assignment of participants.
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
- •Have been diagnosed with lung cancer
- •Reside in a rural county as determined by a Rural Urban Continuum Code (RUC) of 4 or higher
- •Be at least 18 years of age or older
- •Be able to communicate effectively in English
排除标准
- •Have significant psychiatric disturbance that requires a higher level of care
- •Have substance abuse/dependence that requires a higher level of care
- •Are participating in another lung cancer survivorship care intervention
- •Have previously participated in the Kentucky LEADS Lung Cancer Survivorship Care Program
研究组 & 干预措施
Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)
The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) is a targeted and tailored lung cancer survivorship care intervention built on principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement and improve lung cancer outcomes.
干预措施: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (Behavioral)
Enhanced Usual Care (EUC)
The enhanced usual care condition involves usual care plus bibliotherapy and assessment.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2)
时间窗: Baseline (T0) and 6 Months (T2)
The Functional Assessment of Cancer Therapy-Lung (FACT-L) is a 36-item self-report instrument that measures quality life. Scores range from 0 to 144 with higher scores indicating better quality of life.
次要结局
- Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Pain Interference at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Emotional Social Support at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Psychological Distress at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Pulmonary Symptoms at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Smoking Status at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Knowledge of Palliative Care at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
- Change from Baseline (T0) in Lung Cancer Stigma at 6 Months (T2)(Baseline (T0) and 6 Months (T2))
研究者
Jerod L Stapleton, PhD
Professor
University of Kentucky
