Pilot Trial of Clinical Implementation of a Comprehensive Care Program for Early Stage Medically Inoperable/Borderline Operable Lung Cancer Patients Undergoing Stereotactic Radiotherapy (SBRT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Feasibility of implementation of Comprehensive Care program
研究概览
简要总结
Pulmonary (lung) rehabilitation, which is done under the guidance of lung specialists/therapists. It includes breathing exercises, physical exercises, and exercises to increase tolerance of activity (stamina). This type of lung rehab has been shown to improve symptoms, quality of life, breathing, and walking distance. It has also been shown to decrease hospitalization and death rates in chronic obstructive pulmonary disease (COPD) and lung cancer patients.
Comprehensive Care Management Program (CCMP), a program that includes educational sessions for tobacco cessation, phone calls, and a home action plan has also demonstrated benefit in addition to the pulmonary rehabilitation.
In this study, the investigators have an opportunity to identify and intervene with COPD patients. The vast majority of early stage lung cancer patients are much more scared of their cancer than their COPD. Upon identification of COPD and recognition of patient tobacco habits for patients planned to undergo SBRT, interventions can potentially be made that will reduce COPD hospitalization rates, second primary lung cancer rates, and likely death rates. The interventions are broadly available and relatively easily instituted and include the following: seeing a doctor to diagnose their other underlying illness or illnesses (both respiratory and cardiovascular), smoking cessation if they are smokers, and CCMP's and pulmonary rehabilitation which have shown measurable COPD benefits in prior trials.
详细描述
Primary objective: To evaluate the technical feasibility and delivery of a comprehensive program that leads to prevention and management of symptoms of COPD in early stage lung cancer patients undergoing curative therapy, promotes and leads to smoking cessation, and evaluates potentially unknown cardiopulmonary co-morbid or therapeutically-induced diseases in the cancer patient.
Secondary objective(s):
- To document overall survival of patients undergoing lung SBRT plus preventative care, including evaluation and treatment by a pulmonologist and cardiologist in combination with a tobacco cessation program (for those currently smoking or within 6 months of quitting), and pulmonary rehabilitation. Overall survival and other tumor recurrence and survival endpoints will be compared to historical controls.
- To evaluate quality of life (QOL) changes of patients undergoing lung SBRT with usual care plus evaluation and treatment by a pulmonologist and cardiologist in combination with a tobacco cessation program (for those currently smoking), and pulmonary rehabilitation.
- To evaluate primary tumor control, regional control, distant metastasis and progression-free and cause-specific survival rates.
- To evaluate toxicity rates, including pulmonary and cardiotoxicity after SBRT. Diagnosis and management of cardiopulmonary toxicities may be greater for these patients undergoing routine evaluation by specialist physicians.
- To evaluate smoking cessation rates after employing an Ask, Assist and Refer method for smoking cessation.
- To evaluate second primary lung cancer rates and compare them to historical controls.
- To evaluate changes in pulmonary function, 6-minute walk test and V02 max values with participation in pulmonary rehabilitation.
- To document hospitalization rates after SBRT using these preventative care strategies.
- To explore the impact of SBRT on ventilation and changes in functional lung using 4-Dimensional computed tomography(4DCT) before and after SBRT.
- To study the potential impact of SBRT on cardiac function using pre-and post-SBRT EKG and echocardiography.
Patients for this study will be identified in the Radiation Oncology department as being planned to receive SBRT for their lung cancer. All eligibility will be reviewed. Once a patient is deemed eligible and reviewed and signed the informed consent, he/she will be asked to complete the smoking questionnaire available on the state of Michigan (MI) Quitline. If a patient is deemed eligible and decline to enroll, they will be asked to voluntarily complete the American Heart Association (AHA) Smoking Quiz as an eligible patient exit form. Following their completion of this quiz, they will be asked again if they are certain of their desire to decline the study. All enrolled patients will also complete the AHA smoking quiz.
Before Treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Histologically proven diagnosis of non-small cell lung cancer (NSCLC), including the following types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine carcinoma, NSCLC not otherwise specified (NOS) *Patients with large cell neuroendocrine tumors must have staging MRI of the brain (or CT with IV contrast if MRI contraindicated) due to the high rate of central nervous system (CNS) metastasis
- •American Joint Committee on Cancer (AJCC) Lung 7th Edition clinical Stage T1-T2 N0 M0 with tumor less than or equal to 5 cm size
- •Patient will undergo lung SBRT with curative intent
- •Zubrod 0 - 2
- •Patient evaluated by a Thoracic surgeon and deemed medically inoperable or borderline operable (candidate for only limited lung resection, either wedge resection or segmentectomy) within 8 weeks. For borderline operable patients, patient has seen both thoracic surgery and radiation oncology and has declined surgical intervention
- •Baseline pulmonary function tests confirm that patient would medically qualify for Pulmonary Rehabilitation based on current guidelines. This means patient either has COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV or meets the non-COPD qualifying definition below (FVC, forced expiratory volume at one second (FEV1), or diffusing capacity of lung for carbon monoxide (DLCO) < 65%) AND/OR patient is a current smoker (a non-COPD patient that is a smoker still has a modifiable risk factor; this will be a rare condition).
- •Patient is at least 18 years of age
- •Patient is a non-pregnant female and/or a female or male practicing adequate means of birth control
- •Patient has either peripheral or central lung tumor location that is radiographically identifiable, with central locations as defined by either Radiation Therapy Oncology Group (RTOG) 0236 or RTOG 0813 criteria and will be likely to meet dose volume constraints for central mediastinal structures using one of the allowable dose fractionation schedule.
排除标准
- •Patient has had a synchronous primary malignancy, including lung cancer within 2 years, excluding non-invasive cancers or early stage skin cancers
- •Patient has had prior lung or thoracic radiotherapy, including prior lung SBRT
- •Patient is planned to receive adjuvant systemic therapy for the management of this lung malignancy
- •Does not own a functional mobile/cellular communication device (cellular phone, iPhone or iPad), or is not willing to incur any potential plan-specific additional charges
- •Patients who cannot perform the prescribed rehabilitation and assessments
结局指标
主要结局
Feasibility of implementation of Comprehensive Care program
时间窗: 6 months after enrollment
% of enrolled patients who complete study visits
次要结局
- Smoking Cessation(6 months after enrollment)
- Overall Survival(an average of 10 years)
研究者
Inga Grills
Professor, Residency Program Director, Chief Thoracic Section
William Beaumont Hospitals