Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-29 @ 9:32 PM
Study NCT ID:
NCT03267368
Status:
TERMINATED
Last Update Posted:
2020-04-13
First Post:
2017-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Care Program SBRT
Sponsor:
Corewell Health East
Organization:
Study Overview
Official Title:
Pilot Trial of Clinical Implementation of a Comprehensive Care Program for Early Stage Medically Inoperable/Borderline Operable Lung Cancer Patients Undergoing Stereotactic Radiotherapy (SBRT)
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment. 1 pt. enrolled \& withdrew at 6 wk follow-up. No further enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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):
1. 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.
2. 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.
3. To evaluate primary tumor control, regional control, distant metastasis and progression-free and cause-specific survival rates.
4. 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.
5. To evaluate smoking cessation rates after employing an Ask, Assist and Refer method for smoking cessation.
6. To evaluate second primary lung cancer rates and compare them to historical controls.
7. To evaluate changes in pulmonary function, 6-minute walk test and V02 max values with participation in pulmonary rehabilitation.
8. To document hospitalization rates after SBRT using these preventative care strategies.
9. To explore the impact of SBRT on ventilation and changes in functional lung using 4-Dimensional computed tomography(4DCT) before and after SBRT.
10. 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:
All eligibility will be confirmed and pre-treatment standard staging activities (history and physical, zubrod, weight, thoracic surgeon evaluation, chest CT with contrast, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT), Pulmonary Function Test, bloodwork and pregnancy safety evaluation) will have occurred.
A baseline pulmonologist referral will be made within 4 weeks before/after SBRT.
A baseline cardiologist referral will be made within 4 weeks before/after SBRT.
Baseline EKG and echocardiogram (ECHO) will be done prior to the 1st fraction of SBRT.
Pulmonary rehab baseline assessment including a 6 Minute Walk Test, oxygen consumption (VO2 max) will occur prior to treatment.
Charlson Comorbidity Index Evaluation will occur prior to treatment.
Quality of life, Depression, Anxiety, and Craving Assessment questionnaires will be completed.
Subject will also have a urine or saliva Nicotine evaluation and enrollment in the Michigan Tobacco Quitline program which requires a cell phone or tablet owned by the patient. This is a free service within Michigan, available to any smokers, not specific for the study.
SBRT will take place as prescribed by the treating radiation oncologist within the standard parameters. On-Treatment Visits (OTV) will occur weekly during the SBRT and include a history and physical, zubrod (performance score), weight, hospitalization and smoking assessment, and urine or saliva Nicotine evaluation . As part of the study, nicotine replacement is required to be ordered as is daily visits/calls with a smoking cessation specialist.
After completion of radiotherapy, the subject will have weekly visits/calls with the smoking cessation specialist for 6 weeks.
Post-Treatment visits:
At 6 weeks post SBRT-the patient will come back to the radiation oncology clinic for a history and physical, zubrod, and weight. The patient also have pulmonary function testing (PFT), adverse event reporting, 6 minute walk test and pulmonary rehab per plan developed pre-treatment, hospitalization and smoking assessment #1 Research 4DCT, not diagnostic, will be obtained at this visit and done in the radiation oncology department.
The following testing will happen, as stated at 3, 6, 9, 12, 18, 24, and then annually per standard. Procedures specific to this study will be completed at 24 months. Any annual testing is standard and that data will be used at the time of analysis so it is captured in the patient consent and table of events.
* History and physical exam (3, 6, 9, 12 months)
* Performance status and weight (6, 9, 12, 18, 24, + annual)
* Cardiologist evaluation with EKG/ECHO (6 months)
* CT chest with contrast (3, 6, 9, 12, 18, 24, 30, 36, 42, 48 months, then annual)
* FDG PET (3 months)
* PFT (3, 6, 12, 18, 24 months, then annual)
* Bloodwork- Complete blood count (CBC)/Chemistries (3 months)
* Tumor evaluation (3, 6, 9, 12, 18, 24, then annual)
* Adverse event (side effects) evaluation (3, 6, 9, 12, 18, 24, and annual)
* 2nd primary lung cancer documentation (not patient test-study specific notation)-(12, 24 months then annual)
* 6-minute walk test, V02 Max (3, 6, 12, 24, + annual)
* QOL Assessment (3, 6, 9, 12, 18, 24, + annual)
* Hospitalization and Smoking Assessment (3, 6, 9, 12, 18, then every 6 months to 36 months then annual)
* Urine/Saliva Nicotine evaluation (6, 12, 24 months, then annual if needed)
* Depression, Anxiety, and Craving Assessments (6, 12 months) •# 2 Research 4DCT (6 months)
Secondary objective(s):
1. 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.
2. 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.
3. To evaluate primary tumor control, regional control, distant metastasis and progression-free and cause-specific survival rates.
4. 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.
5. To evaluate smoking cessation rates after employing an Ask, Assist and Refer method for smoking cessation.
6. To evaluate second primary lung cancer rates and compare them to historical controls.
7. To evaluate changes in pulmonary function, 6-minute walk test and V02 max values with participation in pulmonary rehabilitation.
8. To document hospitalization rates after SBRT using these preventative care strategies.
9. To explore the impact of SBRT on ventilation and changes in functional lung using 4-Dimensional computed tomography(4DCT) before and after SBRT.
10. 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:
All eligibility will be confirmed and pre-treatment standard staging activities (history and physical, zubrod, weight, thoracic surgeon evaluation, chest CT with contrast, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT), Pulmonary Function Test, bloodwork and pregnancy safety evaluation) will have occurred.
A baseline pulmonologist referral will be made within 4 weeks before/after SBRT.
A baseline cardiologist referral will be made within 4 weeks before/after SBRT.
Baseline EKG and echocardiogram (ECHO) will be done prior to the 1st fraction of SBRT.
Pulmonary rehab baseline assessment including a 6 Minute Walk Test, oxygen consumption (VO2 max) will occur prior to treatment.
Charlson Comorbidity Index Evaluation will occur prior to treatment.
Quality of life, Depression, Anxiety, and Craving Assessment questionnaires will be completed.
Subject will also have a urine or saliva Nicotine evaluation and enrollment in the Michigan Tobacco Quitline program which requires a cell phone or tablet owned by the patient. This is a free service within Michigan, available to any smokers, not specific for the study.
SBRT will take place as prescribed by the treating radiation oncologist within the standard parameters. On-Treatment Visits (OTV) will occur weekly during the SBRT and include a history and physical, zubrod (performance score), weight, hospitalization and smoking assessment, and urine or saliva Nicotine evaluation . As part of the study, nicotine replacement is required to be ordered as is daily visits/calls with a smoking cessation specialist.
After completion of radiotherapy, the subject will have weekly visits/calls with the smoking cessation specialist for 6 weeks.
Post-Treatment visits:
At 6 weeks post SBRT-the patient will come back to the radiation oncology clinic for a history and physical, zubrod, and weight. The patient also have pulmonary function testing (PFT), adverse event reporting, 6 minute walk test and pulmonary rehab per plan developed pre-treatment, hospitalization and smoking assessment #1 Research 4DCT, not diagnostic, will be obtained at this visit and done in the radiation oncology department.
The following testing will happen, as stated at 3, 6, 9, 12, 18, 24, and then annually per standard. Procedures specific to this study will be completed at 24 months. Any annual testing is standard and that data will be used at the time of analysis so it is captured in the patient consent and table of events.
* History and physical exam (3, 6, 9, 12 months)
* Performance status and weight (6, 9, 12, 18, 24, + annual)
* Cardiologist evaluation with EKG/ECHO (6 months)
* CT chest with contrast (3, 6, 9, 12, 18, 24, 30, 36, 42, 48 months, then annual)
* FDG PET (3 months)
* PFT (3, 6, 12, 18, 24 months, then annual)
* Bloodwork- Complete blood count (CBC)/Chemistries (3 months)
* Tumor evaluation (3, 6, 9, 12, 18, 24, then annual)
* Adverse event (side effects) evaluation (3, 6, 9, 12, 18, 24, and annual)
* 2nd primary lung cancer documentation (not patient test-study specific notation)-(12, 24 months then annual)
* 6-minute walk test, V02 Max (3, 6, 12, 24, + annual)
* QOL Assessment (3, 6, 9, 12, 18, 24, + annual)
* Hospitalization and Smoking Assessment (3, 6, 9, 12, 18, then every 6 months to 36 months then annual)
* Urine/Saliva Nicotine evaluation (6, 12, 24 months, then annual if needed)
* Depression, Anxiety, and Craving Assessments (6, 12 months) •# 2 Research 4DCT (6 months)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: