Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT): A Phase II Randomized Supportive Care Intervention Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Study adherence
研究概览
简要总结
This phase II trial tests whether a supportive care intervention (Resiliency among Older Adults Receiving Lung Cancer Treatment [ROAR-LCT]) is effective in improving physical and emotional wellbeing in patients with stage IIIA, IIIB, and IV lung cancer undergoing cancer treatment. Lung cancers are one of the most common cancers. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status. Targeted interventions may address these two risk factors and improve functional status and resilience. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve symptoms and quality of life for patients with cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the potential effectiveness of a novel, supervised virtual health-assisted physical therapy plus relaxation intervention vs. standard of care on the primary outcomes: functional status and overall feasibility of the study design.
SECONDARY OBJECTIVE:
I. To determine the potential effectiveness of the intervention on secondary outcomes: psychological symptoms, and physical capability among older adults with an advanced lung cancer (N=100).
EXPLORATORY OBJECTIVE:
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 60 years
- •Diagnosed with an advanced lung cancer: unresectable stage IIIA, IIIB, or stage IV non-small cell lung cancer (NSCLC) or extensive stage small cell lung cancer (SCLC)
- •Intent to receive treatment from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
- •A score of 2 or higher on the three functional items of the European Quality of Life Five Dimension Five Level Scale (EQ5D5L) patient reported outcome (PRO) assessment
- •Patients are eligible at any time point during their treatment here at Ohio State University (OSU). Rationale for this timeframe is due to the overwhelming nature of the first few visits and uncertainty around an eventual treatment plan. Patients at any stage of their treatment can participate and benefit from a physical therapy and psychosocial intervention. Patients will be approached at their initial visit but the investigators can also offer enrollment at any one of the patients regularly scheduled clinic visits or via phone or email
- •Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
排除标准
- •Prisoners are excluded from participation
- •There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases
结局指标
主要结局
Study adherence
时间窗: Up to 12 weeks
Study adherence will be defined as the completion of 70% of the program sessions, repeated assessments, and collection of biospecimens either at the end of the study period or death, whichever occurs first.
Retention
时间窗: 6 Month
Retention rates will be defined as the percentage of participants not lost to follow-up at 6 months
Amount and duration of therapy that participants were able to complete
时间窗: Week 24
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Preliminary effect on functional status
时间窗: 12 month
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 12 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 12 months to explore if the intervention has both an immediate and sustained impact on function.
次要结局
- Psychological Symptoms(Up to 12 weeks)
- Incidence and severity of toxicity(Up to 12 weeks)
- Physical capability(Up to 12 weeks)
- Psychological symptoms(Up to 12 weeks)
- Physical Endurance(Up to 12 weeks)
- Physical function(Up to 12 weeks)
研究者
Carolyn Presley
Principal Investigator
Ohio State University Comprehensive Cancer Center