Engagement of Veterans With Lung Cancer (EVLC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
详细描述
This study aims to evaluate whether a lay health worker who provides education and support regarding goals of care and symptom management can improve health-related quality of life among Veterans with newly diagnosed lung cancer and those receiving treatment or who have completed treatment within 12 months as compared to usual care. We will also determine whether the intervention reduces acute care use and explore effects on anxiety and depression, patient activation, and goals of care communication. This knowledge is important as it will help to improve care for Veterans with lung cancer.
PRIMARY OBJECTIVES:
i.) Health-related quality of life
SECONDARY OBJECTIVES:
i.) acute care use ii.) patient activation iii.) anxiety and depression iv.) documentation of goals of care (GoC) v.) palliative care use vi.) hospice use
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The statistician analyzing the data will be masked from the randomization assignment. The principal investigator overseeing the trial will have access to the data but will also be masked from randomization assignment.
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
- •Veteran patients with diagnosis of any stage of lung cancer;
- •18 years of age or older;
- •English- or Spanish-speaking;
- •can self-administer questionnaires in English or Spanish;
- •valid telephone number;
- •receiving oncology care at participating sites;
- •currently newly diagnosed or receiving or having completed systemic anti-cancer therapy and/or radiation therapy within 12 months, defined as oral, injection, or intravenous therapy (chemotherapy, targeted therapy, or immunotherapy)
排除标准
- •no capacity to consent;
- •actively receiving hospice care
研究组 & 干预措施
Usual Care - Arm A
Patients randomized to this group will receive usual care provided by their oncology(or primary) clinical team.
干预措施: Usual Care Group (Other)
Intervention Lay Health Worker (LHW) - Arm B
Participants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay health worker (LHW) to assist with healthcare planning, symptom management, and discussions about care preferences and goals.
干预措施: Lay Health Worker (LHW) Planning (Behavioral)
结局指标
主要结局
Health-Related Quality of Life
时间窗: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment
Change in Health-related quality of life using the 36-item validated Functional Assessment of Cancer Therapeutics-Lung (FACT-L) survey.
次要结局
- Emergency Department Visits (Self-reported and Chart Review)(From baseline (time of enrollment) to 12 Months post-enrollment)
- Hospitalization Visits (Self-reported and Chart Review)(From baseline (time of enrollment) to 12 months post-enrollment)
- Patient Activation Measure (PAM-10).(At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment)
- Patient-reported anxiety and depression(At baseline, 3, 6, 9 and 12 months post-enrollment)
- Documentation of goals of care discussions (Chart Review)(At baseline, 3, 6, 9 and 12 months post-enrollment)
- Palliative Care Use (Self-reported and Chart Review)(From baseline (time of enrollment) to 12 months post-enrollment)
- Hospice Care Use (Self-reported and Chart Review)(From baseline (time of enrollment) to 12 months post-enrollment)
研究者
Manali Patel
Staff Oncologist and Investigator
VA Palo Alto Health Care System