<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267368</url>
  </required_header>
  <id_info>
    <org_study_id>2017-151</org_study_id>
    <nct_id>NCT03267368</nct_id>
  </id_info>
  <brief_title>Comprehensive Care Program SBRT</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary (lung) rehabilitation, which is done under the guidance of lung&#xD;
      specialists/therapists. It includes breathing exercises, physical exercises, and exercises to&#xD;
      increase tolerance of activity (stamina). This type of lung rehab has been shown to improve&#xD;
      symptoms, quality of life, breathing, and walking distance. It has also been shown to&#xD;
      decrease hospitalization and death rates in chronic obstructive pulmonary disease (COPD) and&#xD;
      lung cancer patients.&#xD;
&#xD;
      Comprehensive Care Management Program (CCMP), a program that includes educational sessions&#xD;
      for tobacco cessation, phone calls, and a home action plan has also demonstrated benefit in&#xD;
      addition to the pulmonary rehabilitation.&#xD;
&#xD;
      In this study, the investigators have an opportunity to identify and intervene with COPD&#xD;
      patients. The vast majority of early stage lung cancer patients are much more scared of their&#xD;
      cancer than their COPD. Upon identification of COPD and recognition of patient tobacco habits&#xD;
      for patients planned to undergo SBRT, interventions can potentially be made that will reduce&#xD;
      COPD hospitalization rates, second primary lung cancer rates, and likely death rates. The&#xD;
      interventions are broadly available and relatively easily instituted and include the&#xD;
      following: seeing a doctor to diagnose their other underlying illness or illnesses (both&#xD;
      respiratory and cardiovascular), smoking cessation if they are smokers, and CCMP's and&#xD;
      pulmonary rehabilitation which have shown measurable COPD benefits in prior trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective: To evaluate the technical feasibility and delivery of a comprehensive&#xD;
      program that leads to prevention and management of symptoms of COPD in early stage lung&#xD;
      cancer patients undergoing curative therapy, promotes and leads to smoking cessation, and&#xD;
      evaluates potentially unknown cardiopulmonary co-morbid or therapeutically-induced diseases&#xD;
      in the cancer patient.&#xD;
&#xD;
      Secondary objective(s):&#xD;
&#xD;
        1. To document overall survival of patients undergoing lung SBRT plus preventative care,&#xD;
           including evaluation and treatment by a pulmonologist and cardiologist in combination&#xD;
           with a tobacco cessation program (for those currently smoking or within 6 months of&#xD;
           quitting), and pulmonary rehabilitation. Overall survival and other tumor recurrence and&#xD;
           survival endpoints will be compared to historical controls.&#xD;
&#xD;
        2. To evaluate quality of life (QOL) changes of patients undergoing lung SBRT with usual&#xD;
           care plus evaluation and treatment by a pulmonologist and cardiologist in combination&#xD;
           with a tobacco cessation program (for those currently smoking), and pulmonary&#xD;
           rehabilitation.&#xD;
&#xD;
        3. To evaluate primary tumor control, regional control, distant metastasis and&#xD;
           progression-free and cause-specific survival rates.&#xD;
&#xD;
        4. To evaluate toxicity rates, including pulmonary and cardiotoxicity after SBRT. Diagnosis&#xD;
           and management of cardiopulmonary toxicities may be greater for these patients&#xD;
           undergoing routine evaluation by specialist physicians.&#xD;
&#xD;
        5. To evaluate smoking cessation rates after employing an Ask, Assist and Refer method for&#xD;
           smoking cessation.&#xD;
&#xD;
        6. To evaluate second primary lung cancer rates and compare them to historical controls.&#xD;
&#xD;
        7. To evaluate changes in pulmonary function, 6-minute walk test and V02 max values with&#xD;
           participation in pulmonary rehabilitation.&#xD;
&#xD;
        8. To document hospitalization rates after SBRT using these preventative care strategies.&#xD;
&#xD;
        9. To explore the impact of SBRT on ventilation and changes in functional lung using&#xD;
           4-Dimensional computed tomography(4DCT) before and after SBRT.&#xD;
&#xD;
       10. To study the potential impact of SBRT on cardiac function using pre-and post-SBRT EKG&#xD;
           and echocardiography.&#xD;
&#xD;
      Patients for this study will be identified in the Radiation Oncology department as being&#xD;
      planned to receive SBRT for their lung cancer. All eligibility will be reviewed. Once a&#xD;
      patient is deemed eligible and reviewed and signed the informed consent, he/she will be asked&#xD;
      to complete the smoking questionnaire available on the state of Michigan (MI) Quitline. If a&#xD;
      patient is deemed eligible and decline to enroll, they will be asked to voluntarily complete&#xD;
      the American Heart Association (AHA) Smoking Quiz as an eligible patient exit form. Following&#xD;
      their completion of this quiz, they will be asked again if they are certain of their desire&#xD;
      to decline the study. All enrolled patients will also complete the AHA smoking quiz.&#xD;
&#xD;
      Before Treatment:&#xD;
&#xD;
      All eligibility will be confirmed and pre-treatment standard staging activities (history and&#xD;
      physical, zubrod, weight, thoracic surgeon evaluation, chest CT with contrast,&#xD;
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography/computed&#xD;
      tomography (PET/CT), Pulmonary Function Test, bloodwork and pregnancy safety evaluation) will&#xD;
      have occurred.&#xD;
&#xD;
      A baseline pulmonologist referral will be made within 4 weeks before/after SBRT.&#xD;
&#xD;
      A baseline cardiologist referral will be made within 4 weeks before/after SBRT.&#xD;
&#xD;
      Baseline EKG and echocardiogram (ECHO) will be done prior to the 1st fraction of SBRT.&#xD;
&#xD;
      Pulmonary rehab baseline assessment including a 6 Minute Walk Test, oxygen consumption (VO2&#xD;
      max) will occur prior to treatment.&#xD;
&#xD;
      Charlson Comorbidity Index Evaluation will occur prior to treatment.&#xD;
&#xD;
      Quality of life, Depression, Anxiety, and Craving Assessment questionnaires will be&#xD;
      completed.&#xD;
&#xD;
      Subject will also have a urine or saliva Nicotine evaluation and enrollment in the Michigan&#xD;
      Tobacco Quitline program which requires a cell phone or tablet owned by the patient. This is&#xD;
      a free service within Michigan, available to any smokers, not specific for the study.&#xD;
&#xD;
      SBRT will take place as prescribed by the treating radiation oncologist within the standard&#xD;
      parameters. On-Treatment Visits (OTV) will occur weekly during the SBRT and include a history&#xD;
      and physical, zubrod (performance score), weight, hospitalization and smoking assessment, and&#xD;
      urine or saliva Nicotine evaluation . As part of the study, nicotine replacement is required&#xD;
      to be ordered as is daily visits/calls with a smoking cessation specialist.&#xD;
&#xD;
      After completion of radiotherapy, the subject will have weekly visits/calls with the smoking&#xD;
      cessation specialist for 6 weeks.&#xD;
&#xD;
      Post-Treatment visits:&#xD;
&#xD;
      At 6 weeks post SBRT-the patient will come back to the radiation oncology clinic for a&#xD;
      history and physical, zubrod, and weight. The patient also have pulmonary function testing&#xD;
      (PFT), adverse event reporting, 6 minute walk test and pulmonary rehab per plan developed&#xD;
      pre-treatment, hospitalization and smoking assessment #1 Research 4DCT, not diagnostic, will&#xD;
      be obtained at this visit and done in the radiation oncology department.&#xD;
&#xD;
      The following testing will happen, as stated at 3, 6, 9, 12, 18, 24, and then annually per&#xD;
      standard. Procedures specific to this study will be completed at 24 months. Any annual&#xD;
      testing is standard and that data will be used at the time of analysis so it is captured in&#xD;
      the patient consent and table of events.&#xD;
&#xD;
        -  History and physical exam (3, 6, 9, 12 months)&#xD;
&#xD;
        -  Performance status and weight (6, 9, 12, 18, 24, + annual)&#xD;
&#xD;
        -  Cardiologist evaluation with EKG/ECHO (6 months)&#xD;
&#xD;
        -  CT chest with contrast (3, 6, 9, 12, 18, 24, 30, 36, 42, 48 months, then annual)&#xD;
&#xD;
        -  FDG PET (3 months)&#xD;
&#xD;
        -  PFT (3, 6, 12, 18, 24 months, then annual)&#xD;
&#xD;
        -  Bloodwork- Complete blood count (CBC)/Chemistries (3 months)&#xD;
&#xD;
        -  Tumor evaluation (3, 6, 9, 12, 18, 24, then annual)&#xD;
&#xD;
        -  Adverse event (side effects) evaluation (3, 6, 9, 12, 18, 24, and annual)&#xD;
&#xD;
        -  2nd primary lung cancer documentation (not patient test-study specific notation)-(12, 24&#xD;
           months then annual)&#xD;
&#xD;
        -  6-minute walk test, V02 Max (3, 6, 12, 24, + annual)&#xD;
&#xD;
        -  QOL Assessment (3, 6, 9, 12, 18, 24, + annual)&#xD;
&#xD;
        -  Hospitalization and Smoking Assessment (3, 6, 9, 12, 18, then every 6 months to 36&#xD;
           months then annual)&#xD;
&#xD;
        -  Urine/Saliva Nicotine evaluation (6, 12, 24 months, then annual if needed)&#xD;
&#xD;
        -  Depression, Anxiety, and Craving Assessments (6, 12 months) •# 2 Research 4DCT (6&#xD;
           months)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment. 1 pt. enrolled &amp; withdrew at 6 wk follow-up. No further enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">May 23, 2018</completion_date>
  <primary_completion_date type="Actual">May 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, non-randomized, intervention, outcome</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of implementation of Comprehensive Care program</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>% of enrolled patients who complete study visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>an average of 10 years</time_frame>
    <description>Time from diagnosis to recurrence or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking Cessation</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>% of participants who quit smoking</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Smoking</condition>
  <condition>Copd</condition>
  <arm_group>
    <arm_group_label>Comprehensive Care Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulmonary rehab and smoking cessation program/intervention/assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comprehensive Care Program</intervention_name>
    <description>Pulmonary rehabilitation and smoking cessation</description>
    <arm_group_label>Comprehensive Care Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven diagnosis of non-small cell lung cancer (NSCLC), including the&#xD;
             following types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large&#xD;
             cell neuroendocrine carcinoma, NSCLC not otherwise specified (NOS) *Patients with&#xD;
             large cell neuroendocrine tumors must have staging MRI of the brain (or CT with IV&#xD;
             contrast if MRI contraindicated) due to the high rate of central nervous system (CNS)&#xD;
             metastasis&#xD;
&#xD;
          -  American Joint Committee on Cancer (AJCC) Lung 7th Edition clinical Stage T1-T2 N0 M0&#xD;
             with tumor less than or equal to 5 cm size&#xD;
&#xD;
          -  Patient will undergo lung SBRT with curative intent&#xD;
&#xD;
          -  Zubrod 0 - 2&#xD;
&#xD;
          -  Patient evaluated by a Thoracic surgeon and deemed medically inoperable or borderline&#xD;
             operable (candidate for only limited lung resection, either wedge resection or&#xD;
             segmentectomy) within 8 weeks. For borderline operable patients, patient has seen both&#xD;
             thoracic surgery and radiation oncology and has declined surgical intervention&#xD;
&#xD;
          -  Baseline pulmonary function tests confirm that patient would medically qualify for&#xD;
             Pulmonary Rehabilitation based on current guidelines. This means patient either has&#xD;
             COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV or meets the&#xD;
             non-COPD qualifying definition below (FVC, forced expiratory volume at one second&#xD;
             (FEV1), or diffusing capacity of lung for carbon monoxide (DLCO) &lt; 65%) AND/OR patient&#xD;
             is a current smoker (a non-COPD patient that is a smoker still has a modifiable risk&#xD;
             factor; this will be a rare condition).&#xD;
&#xD;
          -  Patient is at least 18 years of age&#xD;
&#xD;
          -  Patient is a non-pregnant female and/or a female or male practicing adequate means of&#xD;
             birth control&#xD;
&#xD;
          -  Patient has either peripheral or central lung tumor location that is radiographically&#xD;
             identifiable, with central locations as defined by either Radiation Therapy Oncology&#xD;
             Group (RTOG) 0236 or RTOG 0813 criteria and will be likely to meet dose volume&#xD;
             constraints for central mediastinal structures using one of the allowable dose&#xD;
             fractionation schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has had a synchronous primary malignancy, including lung cancer within 2&#xD;
             years, excluding non-invasive cancers or early stage skin cancers&#xD;
&#xD;
          -  Patient has had prior lung or thoracic radiotherapy, including prior lung SBRT&#xD;
&#xD;
          -  Patient is planned to receive adjuvant systemic therapy for the management of this&#xD;
             lung malignancy&#xD;
&#xD;
          -  Does not own a functional mobile/cellular communication device (cellular phone, iPhone&#xD;
             or iPad), or is not willing to incur any potential plan-specific additional charges&#xD;
&#xD;
          -  Patients who cannot perform the prescribed rehabilitation and assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inga Grills, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Health System</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Inga Grills</investigator_full_name>
    <investigator_title>Professor, Residency Program Director, Chief Thoracic Section</investigator_title>
  </responsible_party>
  <keyword>Comprehensive Care Program</keyword>
  <keyword>Stereotactic Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267368
org study id: 2017-151
nct id: NCT03267368
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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)
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, non-randomized, intervention, outcome
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of implementation of Comprehensive Care program
time frame: 6 months after enrollment
description: % of enrolled patients who complete study visits
measure: Overall Survival
time frame: an average of 10 years
description: Time from diagnosis to recurrence or death
measure: Smoking Cessation
time frame: 6 months after enrollment
description: % of participants who quit smoking
arm group label: Comprehensive Care Program
arm group type: Experimental
description: Pulmonary rehab and smoking cessation program/intervention/assessment
intervention type: Behavioral
intervention name: Comprehensive Care Program
description: Pulmonary rehabilitation and smoking cessation
arm group label: Comprehensive Care Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Inga Grills, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Inga Grills
investigator title: Professor, Residency Program Director, Chief Thoracic Section
mesh term: Lung Neoplasms
sharing ipd: No