Comprehensive Care Program SBRT

NCT03267368 | Terminated DMC

• 1 other identifier: 2017-151
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Smoking; Copd

Keywords

Comprehensive Care Program; Stereotactic Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementation of Comprehensive Care program

  % of enrolled patients who complete study visits

  6 months after enrollment

Secondary Outcomes (2)

• Overall Survival

  an average of 10 years

• Smoking Cessation

  6 months after enrollment

Study Arms (1)

Comprehensive Care Program

EXPERIMENTAL

Pulmonary rehab and smoking cessation program/intervention/assessment

Behavioral: Comprehensive Care Program

Interventions

Comprehensive Care Program BEHAVIORAL

Pulmonary rehabilitation and smoking cessation

Comprehensive Care Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (2)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Smoking; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Inga Grills, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Residency Program Director, Chief Thoracic Section

Model Details: Prospective, non-randomized, intervention, outcome

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: September 11, 2017
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)