The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
试验速览
- 阶段
- 不适用
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Proportion of intervention arm participants who complete study visits
研究概览
简要总结
This research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.
详细描述
The aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance.
The research study procedures include screening for eligibility.
This study consists of 2 parts. It is expected that about 45 people will take part in this research study.
- In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
- In the second part of this study, about 40 participants will complete 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control).
- These sessions will focus on providing targeted support related to life after cancer treatment. The sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older
- •Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
- •Documented treatment plan with curative intent
- •Ability to read and respond in English
- •Treatment completion eligibility:
- •Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital.
- •RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.
- •If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
- •If final treatment is surgery: within three weeks after hospital discharge following surgery.
排除标准
- •Comorbid health condition that would interfere with study participation
- •Current participation in cognitive behavioral therapy treatment
结局指标
主要结局
Proportion of intervention arm participants who complete study visits
时间窗: 12 weeks
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
Number of participants retained
时间窗: 12 Weeks
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Number of participants enrolled
时间窗: 12 Weeks
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
次要结局
- Change in Hospital Anxiety and Depression Scale score(pre-baseline to 12 weeks)
- Change in Multidimensional Scale of Perceived Social Support score(pre-baseline to 12 Weeks)
- Acceptability of study(Week 12)
- Change in Fear of Cancer Recurrence Scale 7 score(pre-baseline to 12 weeks)
- Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score(pre-baseline to 12 weeks)
研究者
Lara Traeger
Principal Investigator
Massachusetts General Hospital