Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Change in PROMIS Depression Short Form Scores
研究概览
简要总结
This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.
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
- 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
- •New or recurrent AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer
- •18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100
- •3-12 weeks into systemic, infusion-based treatment (chemotherapy, immunotherapy, chemo-immunotherapy)
- •Past month distress score (per electronic health record) of 3/10 or higher OR a Rotterdam Symptom item score of 2 or higher for psychological distress items.
排除标准
- •Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses)
- •Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate
- •Receiving overlapping palliative care or psychological services at the cancer center
- •Unable to speak and read English.
- •Hearing or visual impairment that precludes study participation
研究组 & 干预措施
Pathways
Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.
干预措施: Pathways (Behavioral)
Enhanced Usual Care
Enhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center).
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Change in PROMIS Depression Short Form Scores
时间窗: 12 weeks (Baseline, Post-Intervention)
Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30. Higher scores indicate more depression.
Change in State Hope scores
时间窗: 12 weeks (Baseline, Post-Intervention)
Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.
次要结局
- Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores(12 weeks (Baseline, Post-Intervention))
- Change in PROMIS 15a positive affect scores(12 weeks (Baseline, Post-Intervention))
- Change in FACT-G7 Quality of Life Scores(12 weeks (Baseline, Post-Intervention))
- Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores(12 weeks (Baseline, Post-Intervention))
- Change in PROMIS Anxiety Short Form Scores(12 weeks (Baseline, Post-Intervention))
- Change in Demoralization Scale II Scores(12 weeks (Baseline, Post-Intervention))
研究者
Laurie McLouth
Assistant Professor
University of Kentucky