Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 18
- 主要终点
- Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey
研究概览
简要总结
The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.
详细描述
The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Individuals who have been diagnosed with lung cancer (survivor) or
- •Caregiver of a participating lung cancer survivor
- •Ability to read and write in English
排除标准
- •Individuals with significant psychiatric disturbance that requires a higher level of care
- •Individuals with substance abuse/dependence problem that require a higher level of care
- •Incarcerate individuals or individuals detained within the legal system
结局指标
主要结局
Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey
时间窗: 1 week post-intervention up to 1 month post-intervention
Participating survivor intervention acceptability (1A)
Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey
时间窗: 1 week post-intervention up to 1 month post-intervention
Participating survivor intervention satisfaction (1B)
Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data
时间窗: 1 week post-intervention up to 1 month post-intervention
Participating survivor intervention uptake (1C)
次要结局
- Secondary Intervention Feasibility A: Intervention accrual rate(6 months post-baseline)
- Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey(6 months post-baseline)
研究者
Jamie Studts
Principal Investigator
University of Kentucky