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Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02123797
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Raymond Osarogiagbon, MD, Baptist Memorial Health Care Corporation

Brief Summary:

Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The overall year survival rate has only improved from 12% to 17% in 33 years. This failure reflects the innate lethality of lung cancer, but also reflects defects in patient care delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage), selection of appropriate treatment, and finally ends with patient outcomes. At each step are multiple options and independent specialists, each one engaged by a process of sequential referrals in the serial care model. This process is often not user-friendly, is riddled with inefficiency, delays, and outcome variances.

The coordinated multidisciplinary model, in which patients and their doctors collaborate to provide evidence-based care, is believed by experts to be superior, but has few examples of successful implementation. The implementation gap exists because of the paucity of good quality data, and lack of implementation know-how.

Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a racially, culturally, economically and geographically diverse population. The investigators research group has shown how poor quality care impairs patient survival in this region and in the greater US. The investigators have linked patient survival to compliance with multidisciplinary care plans. In this project, the investigators propose to rigorously test the impact of the multidisciplinary care model on patient outcomes in a community-based, private practice environment, similar to where 70% of lung cancer care is delivered in the US.

The objective of this study is to provide high-level evidence of the impact of multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as a model of care in which patients, their care-givers and key specialists concurrently and directly evaluate the same patients in the presence of the patients and their informal caregivers, in order to develop evidence-based consensus care plans


Condition or disease
Lung Cancer

Detailed Description:
Within the Baptist Memorial Health Care system, the Multidisciplinary Thoracic Oncology Program has two components: Primarily, the program is centered in a multidisciplinary clinic, wherein patients and their informal caregivers are seen by multiple specialists at a single appointment time; secondarily, the program includes a multidisciplinary conference, wherein all of the specialists potentially involved in lung cancer care discuss patients referred for presentation and make consensus recommendations for care. This study focuses primarily on the experience and outcomes of care delivered to patients evaluated in the multidisciplinary clinic. However, data from the conference will also be included in some aspects of the study. The goal is to improve the access and quality of thoracic oncologic care delivery within the Baptist Healthcare System The investigators specific aim is to perform a prospective, matched cohort comparative effectiveness study of patients receiving serial vs. multidisciplinary care, with key patient-centered endpoints (survival, stakeholder satisfaction with the care experience, timeliness and stage-appropriateness of care, quality of staging). Serial care is defined as the current system of linear, sequential, referral-based care delivery.

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Study Type : Observational
Actual Enrollment : 781 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology
Actual Study Start Date : October 9, 2014
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Multidisciplinary Clinic Patients
: 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients
Serial Care Patients
150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients = 450 patients Since Baptist Health Care System manages >800 new cases each year, 300 of which are expected to be seen in multidisciplinary clinic, in practice, we conservatively expect to be able to recruit 150 cases from multidisciplinary clinic and 300 matched serial care controls (1:2 match) in 18 months.
Multidisciplinary Caregivers
Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time).
Serial Care Caregivers
Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery).
Clinical Providers
Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study.



Primary Outcome Measures :
  1. Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]
    Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  2. Thoroughness of Invasive Mediastinal Staging, MD vs SC [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]
    Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence of mediastinal nodal metastasis. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  3. Thoroughness of Bi-Modal Staging Practice, MD vs SC [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]
    Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  4. Thoroughness of Tri-Modal Staging Practice, MD vs SC [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]
    Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  5. Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]

    Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  6. Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]

    Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence mediastinal nodal metastasis.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  7. Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]

    Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  8. Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]

    Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  9. Stage-Appropriateness Treatment Selection, MD vs SC [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]

    Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

    For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy).


  10. Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months ]

    Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN).

    For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy).

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  11. Timeliness of Communication, MD vs SC(Conference) [ Time Frame: Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program ]
    Number of patients for whom formal, verified communication of care management decisions was made to all team members (providers inside and outside the multidisciplinary program, patients and their care-givers) within 48 hours of a care recommendation being made. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  12. Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months ]
    Number of patients for whom all recommendations made at the initial multidisciplinary conference were completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.

  13. Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months ]

    Number of patients for whom all initial conference recommendations were completed, excluding conditional recommendations for which the prior condition was not met. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.

    E.g., if a recommendation was to have a PET/CT and then a staging biopsy if the PET showed suspicious metastatic disease, the staging biopsy recommendation was excluded from the concordance measure if the PET/CT did not happen or was negative.


  14. Concordance Rate for Any Conference Recommendation, MD vs SC (Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months ]
    Number of patients for whom any initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.

  15. Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months ]

    Number of patients for whom the overall initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.

    The hierarchy to rank recommendations, from highest priority to lowest, was (1) treatment, (2) staging, (3) diagnosis, (4) surveillance.

    If a patient had a treatment recommendation and it happened, he/she was concordant. If treatment was recommended and it did not happen, he/she was discordant. If no treatment recommendation was made, then concordance was measured by whether or not the staging recommendation was met. If no staging recommendation was made, then the diagnostic recommendation was given priority for a concordance measurement. If no diagnostic recommendation, then a surveillance recommendation was used to measure overall concordance.


  16. Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference) [ Time Frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months ]
    Number of patients for whom the treatment recommendation made at the initial conference presentation was completed, excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  17. Baseline Patient Survey Response Rate, MD vs SC [ Time Frame: Baseline ]
    Number of patients who completed a baseline patient survey

  18. 3-month Patient Survey Response Rate, MD vs SC [ Time Frame: Within 30 days of 3 months after baseline survey administration ]
    Number of patients who completed a 3-month survey

  19. 6-Month Patient Survey Response Rate, MD vs SC [ Time Frame: Within 30 days of 6 months after baseline survey administration ]
    Number of patients who completed a 6-month survey

  20. Patient Survey Scores at Baseline, MD vs SC [ Time Frame: Baseline ]

    Scores from patient surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken.

    Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range: 0-4 (higher is better) Financial burden of care - assessment of financial burden of care; range: 3-6 (sum of 3 items, higher is worse) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 1-5 (sum of 2 items, higher is better) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) (descriptions continued in 3 month survey description)


  21. Patient Survey Scores at 3 Months, MD vs SC [ Time Frame: Within 30 days of 3 months after baseline survey administration ]

    Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken.

    (continued from baseline) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-21 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 0-18 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Physical/Social/Functional well-being - health-related quality of life relating to physical/social/functional well-being; range 0-28 (each a sum of 7 items, higher is better) (description continues in 6 month survey description)


  22. Patient Survey Scores at 6 Months, MD vs SC [ Time Frame: Within 30 days of 6 months after baseline survey administration ]

    Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken.

    (cont) Emotional well-being - health-related quality of life related to emotional well-being; range 0-30 (sum of 6 items, higher is better) Lung cancer specific QOL - health-related quality of life related to lung cancer diagnosis; range: 0-36 (sum of 9 items, higher is better) Total Summary Score FACTL - full survey, functional assessment of cancer therapy - lung; range: 0-136 (sum of 36 items, higher is better) Generic Score FACTG - full survey, functional assessment of cancer therapy - general; range: 0-108 (sum of 27 items, higher is better) Trial Outcome Index - health related quality of life - trial outcome index; range: 0-84 (sum of 23 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items each, higher is worse)


  23. Baseline Caregiver Survey Response Rate, MD vs SC [ Time Frame: Baseline ]
    Number of caregivers who completed a baseline patient survey

  24. 3-month Caregiver Survey Response Rate, MD vs SC [ Time Frame: Within 30 days of 3 months after baseline survey administration ]
    Number of caregivers who completed a 3-month survey

  25. 6-Month Caregiver Survey Response Rate, MD vs SC [ Time Frame: Within 30 days of 6 months after baseline survey administration ]
    Number of caregivers who completed a 6-month survey

  26. Caregiver Survey Scores at Baseline, MD vs SC [ Time Frame: Baseline ]

    Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken.

    Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range:0-4 (higher is better) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 0-2 (higher is better) Satisfaction patient can complete treatment plan; range: 0-2 (higher is better) (continued in 3 month survey description)


  27. Caregiver Survey Scores at 3 Months, MD vs SC [ Time Frame: Within 30 days of 3 months after baseline survey administration ]

    Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken.

    (cont) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-28 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 6-24 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items, higher is worse) (continued in 6 month survey description)


  28. Caregiver Survey Scores at 6 Months, MD vs SC [ Time Frame: Within 30 days of 6 months after baseline survey administration ]

    Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken.

    (cont) Physical Functioning QOL - 10 items; Physical Health Problems QOL - 4 items; Pain QOL - 2 items; General health perceptions - 5 items; Energy/fatigue QOL - 4 items; Social Functioning QOL - 2 items; Emotional health problems QOL - 3 items; Emotional well-being QOL - 5 items.

    All health related quality of life measures are from the SF-36 survey tool, and use a range of 0-100 mean score (higher is better).


  29. Timeliness of Care, MD vs SC [ Time Frame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below ]
    Aggregate time in days from enrollment to a specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

  30. Timeliness of Care, MD vs SC (Conference) vs SC (no Conference) [ Time Frame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below ]

    Aggregate time in days from enrollment to specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  31. Clinical Provider Survey Responses - Ease of Referring Patients to the Conference [ Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed ]
    Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.

  32. Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference [ Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed ]
    Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.

  33. Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients [ Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed ]
    Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.

  34. Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient [ Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed ]
    Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.

  35. Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient [ Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed ]
    Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.

  36. Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment [ Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed ]
    Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.

  37. Patient Overall Survival [ Time Frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years ]
    Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.

  38. Patient Overall Survival With SC Further Broken Down [ Time Frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years ]

    Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.


  39. Patient Disease/Progression Free Survival [ Time Frame: measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years ]
    Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.

  40. Patient Disease/Progression Free Survival With SC Further Broken Down [ Time Frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years ]

    Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.

    This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung Cancer Patients coming through the Baptist health care system
Criteria

Inclusion Criteria:

- All patients who undergo care for lung cancer or an undiagnosed lung mass within the Baptist Memorial Health Care Corporation's hospitals from January 1, 2009 until the end of the defined study period will be eligible for inclusion in the data collection for this study. In addition, caregivers of patients within the same institution and within the study window, clinical care providers (doctors and nurses) who have taken care of patients within the eligible institutions during the study window.

Exclusion Criteria:

  • Patients who do not have a radiology-identified lung lesion or lung cancer are excluded from this study.
  • Patients not receiving care within the Baptist Memorial Healthcare Corporation are excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123797


Locations
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United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Baptist Memorial Health Care Corporation
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Raymond Osarogiagbon Baptist Memorial Health Care Corporation
  Study Documents (Full-Text)

Documents provided by Raymond Osarogiagbon, MD, Baptist Memorial Health Care Corporation:
Statistical Analysis Plan  [PDF] March 9, 2015
Informed Consent Form: Patient ICF  [PDF] November 10, 2016
Informed Consent Form: Care Giver ICF  [PDF] November 10, 2016
Informed Consent Form: Provider ICF  [PDF] November 10, 2016
Study Protocol  [PDF] March 9, 2015

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raymond Osarogiagbon, MD, Director, Thoracic Oncology Research Group, Mutidisciplinary Program, Baptist Memorial Health Care Corporation
ClinicalTrials.gov Identifier: NCT02123797    
Other Study ID Numbers: The Milestone Project
First Posted: April 28, 2014    Key Record Dates
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No