Pulmonary Rehabilitation Before Lung Cancer Resection
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer (NSCLC), Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Alliance for Clinical Trials in Oncology

NCI Version date: 7/28/2017 
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Update #3 
 
 
 
ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY 
 
ALLIANCE A221502 
 
PULMONARY REHABILITATION BEFORE LUNG CANCER RESECTION 
A Limited Access Study 
ClinicalTrials.gov Identifier: TBD 
Study Chair 
Roberto Benzo, MD, MSc 
 
 
 
 
 
Community Oncology Co-chair 
Thoracic Surgery Co-Chair 
 
 
 
 
 
 
 
Symptom Intervention Committee Chair 
Respiratory Committee Chair 
 
 
 
   
  
 
 
Primary Statistician 
Secondary Statistician 
 
 
 
 
 
 
 
Data Manager 
Protocol Coordinator 
 
 
 
 
 
 
Participating Organizations 
Alliance/Alliance for Clinical Trials in Oncology,  
ECOG-ACRIN / ECOG-ACRIN Cancer Research Group, NRG / NRG Oncology, SWOG / SWOG   
Limited to the following institutions: 
 
Mayo Clinic Cancer Center (MN026)(Alliance, ECOG,NRG) 
HSHS St. Vincent Hospital (WI027)(Alliance, SWOG, ECOG,NRG) 
Mayo Clinic in Florida (FL080) (Alliance, ECOG,NRG) 
London Health Sciences Centre (11137)(Alliance, NRG, CCTG) 
Baptist Health Lexington (KY026)(SWOG, ECOG) 
Mary Washington Hospital (VA056)(Alliance, ECOG, NRG) 
Baylor University Medical Center (TX012)(Alliance, SWOG) 
Medical University of South Carolina (SC008)(Alliance, SWOG, ECOG, 
NRG) 
Billings Clinic (MT002)(Alliance, ECOG, NRG) 
Rush University Medical Center (IL043)(Alliance, ECOG, NRG) 
Carle Cancer Center (IL168)(Alliance, SWOG, ECOG, NRG) 
Spartanburg Regional Medical Center (SC024)(Alliance, SWOG, NRG) 
Columbus NCORP (COLUMBUS)(Alliance, SWOG,ECOG, NRG) 
Stony Brook Cancer Center (NY184)(Alliance, ECOG, NRG) 
Franciscan St. Francis Health (IN087)(Alliance, SWOG,NRG) 
University of Maryland Medical System (MD015)(Alliance, NRG) 
Henry Ford Health Systems (MI026)(Alliance, SWOG, ECOG, NRG) 
 
                                      

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Study Resources: 
Medidata Rave iMedidata portal 
 
OPEN (Oncology Patient Enrollment Network) 
 
 
Protocol Contacts: 
 
Alliance Central Protocol Operations 
 Program Office 
 
 
Alliance Statistics and Data Center 
 
 
A221502 Nursing Contacts 
  
  
 
 
 
 
Protocol-related questions may be directed as follows: 
Questions 
Contact (via email) 
Questions regarding patient eligibility, treatment, 
and dose modification: 
Study Chair, Nursing Contact, Protocol 
Coordinator, and (where applicable) Data 
Manager 
Questions related to data submission, RAVE or 
patient follow-up: 
Data Manager  
Questions regarding the protocol document and 
model informed consent: 
Protocol Coordinator 
Questions related to IRB review 
Alliance Regulatory Inbox 
 
Questions regarding CTEP-AERS reporting: 
Regulatory Affairs Manager 
 
 
Questions regarding specimens/specimen 
submissions: 
appropriate Alliance Biorepository  
 
Document History 
Effective Date: 
 
 
Activation 
03/15/2017 
 
 
Update 1  
04/01/2017 
 
 
Update 2 
06/15/2017 
 
 
Update 3 
08/15/2017 
 
 
 
 
 
 

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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION 
For regulatory requirements 
 
For patient enrollments: 
For study data submission 
Regulatory documentation must 
be submitted to the CTSU via 
the Regulatory Submission 
Portal. 
Regulatory Submission Portal: 
(Sign in at 
,            
and select the Regulatory 
Submission sub-tab under the 
Regulatory tab.)  
 
Institutions with patients 
waiting that are unable to use 
the Portal should alert the 
CTSU Regulatory Office 
immediately at 
 
to receive further instruction 
and support. 
 
Contact the CTSU Regulatory 
Help Desk at 
 
for regulatory assistance. 
Please refer to the patient 
enrollment section of the protocol 
for instructions on using the 
Oncology Patient Enrollment 
Network (OPEN) which can be 
accessed at 
 
Contact the CTSU Help Desk 
with any OPEN-related questions 
at 
. 
 
Data collection for this study 
will be done exclusively through 
Medidata Rave.  Please see the 
data submission section of the 
protocol for further instructions.  
 
Do not submit study data or 
forms to CTSU Data Operations. 
Do not copy the CTSU on data 
submissions. 
 
The most current version of the study protocol and all supporting documents must be downloaded 
from the protocol-specific Web page of the CTSU Member Web site located at
.  
Access to the CTSU members’ website is managed through the Cancer Therapy and Evaluation Program 
- Identity and Access Management (CTEP-IAM) registration system and requires user log on with 
CTEP-IAM username and password. Permission to view and download this protocol and its supporting 
documents is restricted and is based on person and site roster assignment housed in the CTSU RSS.   
 
For clinical questions (i.e. patient eligibility or treatment-related) see the Protocol Contacts, Page 2  
 
For non-clinical questions (i.e. unrelated to patient eligibility, treatment, or clinical data 
submission) contact the CTSU Help Desk by phone or e-mail:  
CTSU General Information Line – 
.  All calls and 
correspondence will be triaged to the appropriate CTSU representative.  
The CTSU Website is located at 
. 
 
 

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PULMONARY REHABILITATION BEFORE LUNG CANCER RESECTION 
 
 
Eligibility Criteria (see Section 3.2) 
Required Initial 
Laboratory Values 
Patient is scheduled to undergo NSCLC resection: VATS or  open 
thoracotomy for: limited resection, lobectomy, or pneumonectomy. 
None 
A doctor diagnosis of COPD. 
 
Patient is a current or ex-smoker with a smoking history of ≥ 10 pack yrs. (see Section 3.2.3) 
Age ≥ 18 years. 
 
 
 
 
Schema 
 
 
 
 
R 
 
 
 
 
 
 
 
 
A 
 
10 Sessions of preoperative Pulmonary 
Rehabilitation over two weeks 
 
 
 
 
 
 
N 
 
 
 
 
 
Schedule 
Surgery 
 
D 
 
 
Surgery 
 
Follow-up 
at 3 and 6 
months 
 
O 
 
 
 
 
 
M 
 
Standard care of preoperative 
preparation plus activity incentive 
pedometer/exercise routine 
 
 
 
 
I 
 
 
 
 
 
 
 
Z 
 
 
 
 
 
 
 
E 
 
 
 
 
 
 
 
 
 
 
 
Please refer to the full protocol text for a complete description of the eligibility criteria and 
treatment plan. 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
Section 
Page 
TABLE OF CONTENTS ........................................................................................................................... 5 
1.0.  
BACKGROUND .............................................................................................................................. 7 
1.1  
Study Rationale .............................................................................................................................. 7 
1.2 
Significance and Innovation of this Study ...................................................................................... 7 
1.3 
Study Overview .............................................................................................................................. 8 
2.0 
OBJECTIVES .................................................................................................................................. 8 
2.1 
Primary objective ........................................................................................................................... 8 
2.2 
Secondary objectives ...................................................................................................................... 8 
3.0 
PATIENT SELECTION ................................................................................................................. 9 
3.1 
On-Study Guidelines ...................................................................................................................... 9 
3.2 
Eligibility Criteria........................................................................................................................... 9 
4.0 
PATIENT REGISTRATION ......................................................................................................... 9 
4.1 
CTEP Investigator Registration Procedures ................................................................................... 9 
4.2 
CTEP Associate Registration Procedures / CTEP-IAM Account ................................................ 10 
4.3 
CTSU Site Registration Procedures ............................................................................................. 10 
4.4 
Patient Registration Requirements ............................................................................................... 12 
4.5 
Patient Registration/Randomization Procedures. ......................................................................... 12 
4.6  
Stratification Factors .................................................................................................................... 13 
5.0 
STUDY IMPLEMENTATION ..................................................................................................... 13 
5.1 
PR Clinic Requirements ............................................................................................................... 13 
5.2 
PR Manual and Training Requirements ....................................................................................... 13 
5.3 
Patient Recruitment ...................................................................................................................... 14 
5.4 
Patient materials ........................................................................................................................... 14 
5.5 
Study Calendar ............................................................................................................................. 15 
6.0 
DATA SUBMISSION .................................................................................................................... 15 
6.1 
Data Collection and Submission .................................................................................................. 15 
6.2 
Patient questionnaire booklets ...................................................................................................... 16 
6.3 
Hospital records ............................................................................................................................ 16 
7.0 
STUDY INTERVENTION ........................................................................................................... 17 
7.1 
Intervention group procedures ...................................................................................................... 17 
7.2 
Control Group Procedures ............................................................................................................ 18 
8.0 
ADVERSE EVENTS ..................................................................................................................... 19 
9.0 
MEASURES ................................................................................................................................... 19 
9.1 
Chronic Respiratory Questionnaire (CRQ): ................................................................................. 19 
9.2 
MRC: Medical Research Council Dyspnea Score (MRC): .......................................................... 19 
9.3 
Linear Analog Self-Assessment (LASA): .................................................................................... 19 
10.0 
END OF INTERVENTION .......................................................................................................... 19 
10.1 Duration of Treatment .................................................................................................................. 19 
10.2 Managing ineligible patients and registered patients who never receive protocol intervention ... 19 
11.0 
STATISTICAL CONSIDERATIONS ......................................................................................... 20 
11.1 Study Overview ............................................................................................................................ 20 
11.2 Sample Size, Accrual Time, and Study Duration ......................................................................... 20 

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11.3 Statistical Design and Analysis for the Primary Endpoint ........................................................... 20 
11.4 Supplementary Analysis Plans ..................................................................................................... 21 
11.5 Study Monitoring ......................................................................................................................... 22 
11.6 Study Reporting ............................................................................................................................ 22 
11.7 Descriptive Factors ....................................................................................................................... 22 
11.8 Inclusion of Women and Minorities ............................................................................................. 22 
12.0 
REFERENCES .............................................................................................................................. 23 
13.0 
MODEL CONSENT FORM ......................................................................................................... 25 
APPENDIX I ............................................................................................................................................. 31 
APPENDIX II: FOLLOW UP BOOKLET ............................................................................................ 46 
APPENDIX III: PAIN SCALE & HOSPITAL EXPERIENCE ........................................................... 60 
APPENDIX IV: CHECKLIST FOR MEDICAL RECORDS .............................................................. 61 
 

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1.0.  BACKGROUND 
1.1  
Study Rationale 
Definitive assessment of the efficacy of preoperative Pulmonary Rehabilitation (PR) can only 
be addressed through a randomized, controlled clinical trial. Performing this protocol with a 
multicenter design ensures that the results are not unique to a narrow population or center. 
We plan to obtain definitive evidence for the effectiveness of a short preoperative PR protocol 
on the recovery from a curative surgical resection in patients with non-small cell lung cancer 
(NSCLC) and Chronic Obstructive Pulmonary Disease (COPD). 
1.2 
Significance and Innovation of this Study 
Of all cancers in men and women, lung cancer is the number one killer in the United States. 
With 80% of those cases comprised of NSCLC, complete surgical resection is currently the only 
curative treatment. However, many patients with resectable lung cancer have COPD, which 
increases their risk of postoperative complications and their likelihood of being considered 
“inoperable.” It is estimated that 80% of patients with lung cancer have COPD, and about one-
fourth have severe COPD1. While the presence of moderate or severe COPD may not absolutely 
contraindicate surgery, the increased morbidity and mortality associated with lung cancer 
treatment highlights the need for new preoperative interventions to improve clinical outcomes. 
There is no intervention that can decrease the morbidity of lung cancer resection in patients 
emotionally frail or with poor lung function2, 3. Modifying the risk of postoperative pulmonary 
complications is not simple in patients with severe or clinically significant COPD. While 
comprehensive pharmacologic treatment is warranted, no evidence suggests that any 
pharmacologic intervention reduces perioperative risk. Pre-operative PR is one of the few 
proposed interventions in the literature that has been suggested to reduce the risk of post-
operative complications.  The role of smoking cessation as a pre-operative intervention is not 
clear.  
Psychological distress is very prevalent in COPD and adds more risk to having a post-operative 
complication.  Pulmonary Rehabilitation and stress reduction have been recommended in the 
last decade to decrease operative risk.   
PR as a preoperative intervention has been repeatedly recommended in patients with poor lung 
function undergoing lung cancer resection,2, 4-8 but existing protocols are not suitable for the 
preoperative setting and do not fit into the limited window of time available between diagnosis 
and surgical resection of lung cancer. Furthermore, despite recommendations, no randomized or 
large clinical series have been published to date, testing the effect of the current protocols of PR 
on post-operative outcome or recovery from surgery. The size of all reports (<25 patients) from 
centers that have large surgical volumes, and the lack of any randomized studies, have prompted 
questions regarding the feasibility of standard PR as a preoperative intervention9,10.  
Our preliminary work, based on NCI K23CA106544, developed and pilot tested a short PR that 
was feasible and likely very effective on postoperative outcomes and has become the foundation 
of this proposal. Our preliminary work also pointed out the clinical limitations of a lengthy 4-
week preoperative PR (standard protocol) as patients and providers do not want to postpone the 
surgery.  Reports over the past decade have consistently shown that quality of life is an 
independent predictor of overall survival for patients with lung cancer, independent of 
performance status and other potentially surrogate biomarkers11-13.  
In our preliminary work, we defined a feasible protocol of preoperative PR that enhanced the 
current methods of PR with new components that include: mindfulness during movements to 
promote patient’s self-efficacy and emotional balance, inspiratory muscle training and slow 

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breathing awareness (mindfulness of the breath through pursed lips breathing).  Mindfulness has 
well known stress reduction properties and improves quality of life. Self-efficacy or the 
confidence in one’s ability to perform a specific behavior or task is critical to a patient’s ability 
to manage the physical and psychological challenges of cancer treatment. In addition, inspiratory 
muscle training and slow breathing awareness, not routinely used in PR, have been associated 
with better post-operative outcomes for thoracic surgery. This innovative preoperative 
intervention, supported by our preliminary results, may decrease operative morbidity and 
improve recovery following curative lung cancer resection. 
The present research team includes Dr. Sloan and colleagues who have repeatedly demonstrated 
over the past fifteen years a relationship particularly for patients with lung cancer between 
quality of life and other treatment outcomes including survival14-16. Furthermore, specifically 
among patients with advanced lung cancer, a palliative care program that included a behavioral 
intervention was demonstrated to improve quality of life and survival among NSCLC patients2. 
Studies showed that a consistent proportion of patients undergoing lung resection exhibit an 
important postoperative worsening in their QOL and physical activity17-19 especially in the first 
3 to 6 months after surgery20 and no study to date prospectively assessed the trajectory of quality 
of life or physical activity after lung resection. The latter is particularly relevant in patients with 
COPD and resectable lung cancer that carries poorer survival and quality of life compared to 
non-COPD patients.  
This randomized clinical trial, first of its kind, will likely reveal the benefit of behavioral 
interventions for patients with lung cancer and COPD facing surgical resection.  This could 
dramatically change how behavioral interventions are used in oncology. 
1.3 
Study Overview 
This is a study funded by the National Institute of Health.  Prospectively, 194 patients will be 
randomized to either ten sessions of preoperative PR vs. standard care at a number of healthcare 
centers throughout the United States.  The rationale for the need of this research is the lack of 
any well proven risk-reducing intervention that may decrease the morbidity of lung cancer 
resection in patients with COPD or that may improve their quality of life trajectory, a meaningful 
outcome in the overall disease progression. The proposed intervention is unique as it combines 
exercise and behavioral interventions that were pilot tested in a randomized single-blinded 
controlled design in the proposed population and proved feasible and potentially effective. 
The aim is to test the effect of the proposed rehabilitation on length of stay, pulmonary 
complications and quality of life trajectory.  
2.0 
OBJECTIVES  
2.1 
Primary objective  
2.1.1 To prospectively determine the effect of 10 sessions of customized preoperative PR on the 
length of hospital stay in patients that undergo a lung cancer resection and have COPD 
compared to a matched control group.  
Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the length 
of hospital stay. 
2.2 
Secondary objectives 
2.2.1 To prospectively determine the effect of 10 sessions of customized preoperative PR on the 
number of postoperative complications in patients that undergo a lung cancer resection and 
have COPD compared to a matched control group.  

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Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the 
number of postoperative pulmonary complications. 
2.2.2 To prospectively determine the effect of a 10-session preoperative PR on the trajectory of 
quality of life at 3 and 6 months after the curative resection compared to a matched control 
group.  
Hypothesis: Ten sessions of customized preoperative PR will significantly and 
meaningfully (more than the minimal clinically important difference) improve quality of 
life after surgery compared to a control group. 
3.0 
PATIENT SELECTION 
For questions regarding eligibility criteria, see the Study Resources page. Please note that the Study 
Chair cannot grant waivers to eligibility requirements.  
3.1 
On-Study Guidelines 
This clinical trial can fulfill its objectives only if patients appropriate for this trial are enrolled. 
All relevant medical and other considerations should be taken into account when deciding 
whether this protocol is appropriate for a particular patient. Physicians should consider the risks 
and benefits of any therapy, and therefore only enroll patients for whom this treatment is 
appropriate.  
Physicians should recognize that the following may render the patient inappropriate for this 
protocol: 
• 
Psychiatric illness which would prevent the patient from giving informed consent. 
3.2 
Eligibility Criteria  
Use the spaces provided to confirm a patient’s eligibility by indicating Yes or No as appropriate. 
It is not required to complete or submit this page. 
___ 
3.2.1 
Patient is scheduled to undergo NSCLC resection: video assisted thoracoscopy 
(VATS) or open thoracotomy for: limited resection, lobectomy, or pneumonectomy. 
Surgery must not be scheduled to take place < 3 weeks after registration. 
___ 
3.2.2 
Patient has a doctor diagnosis of COPD. 
___ 
3.2.3 
Patient is a current or ex-smoker with a smoking history of ≥ 10 pack years. (Calculated 
by multiplying the number of packs of cigarettes smoked per day by the number of 
years the person has smoked. For example, 1 pack-year is equal to smoking 20 
cigarettes (1 pack) per day for 1 year, or 40 cigarettes per day for half a year, and so 
on). 
___ 
3.2.4 
Age ≥ 18 yrs. 
4.0 
PATIENT REGISTRATION 
4.1 
CTEP Investigator Registration Procedures 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy 
require all investigators participating in any NCI-sponsored clinical trial to register and to renew 
their registration annually. 
Registration requires the submission of: 
Human Subject Protection (HSP) training certificate 

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4.2 
CTEP Associate Registration Procedures / CTEP-IAM Account 
The Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) 
application is a web-based application intended for use by both Investigators (i.e., all physicians 
involved in the conduct of NCI-sponsored clinical trials) and Associates (i.e., all staff involved 
in the conduct of NCI-sponsored clinical trials). 
Associates will use the CTEP-IAM application to register (both initial registration and annual 
re-registration) with CTEP and to obtain a user account. 
Investigators will use the CTEP-IAM application to obtain a user account only. (See CTEP 
Investigator Registration Procedures above for information on registering with CTEP as an 
Investigator, which must be completed before a CTEP-IAM account can be requested.) 
An active CTEP-IAM user account will be needed to access all CTEP and CTSU (Cancer Trials 
Support Unit) websites and applications, including the CTSU members’ website. 
Additional 
information 
can 
be 
found 
on 
the 
CTEP 
website 
at 
.  For questions, please 
contact 
the 
CTEP 
Associate 
Registration 
Help 
Desk 
by 
email 
at 
. 
4.3 
CTSU Site Registration Procedures 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
IRB Approval:   
Each investigator or group of investigators at a clinical site must obtain IRB approval for this 
protocol and submit IRB approval and supporting documentation to the CTSU Regulatory 
Office before they can be approved to enroll patients.  Assignment of site registration status in 
the CTSU Regulatory Support System (RSS) uses extensive data to make a determination of 
whether a site has fulfilled all regulatory criteria including but not limited to: an active Federal 
Wide Assurance (FWA) number, an active roster affiliation with the Lead Network or a 
participating organization, a valid IRB approval, and compliance with all protocol specific 
requirements. 
Sites participating on the NCI CIRB initiative that are approved by the CIRB for this study are 
not required to submit IRB approval documentation to the CTSU Regulatory Office. For sites 
using the CIRB, IRB approval information is received from the CIRB and applied to the RSS in 
an automated process. Signatory Institutions must submit a Study Specific Worksheet for Local 
Context (SSW) to the CIRB via IRBManager to indicate their intent to open the study locally.  
The CIRB’s approval of the SSW is then communicated to the CTSU Regulatory Office.  In 
order for the SSW approval to be processed, the Signatory Institution must inform the CTSU 
which CIRB-approved institutions aligned with the Signatory Institution are participating in the 
study. 
4.3.1 Downloading Site Registration Documents:   
Site registration forms may be downloaded from the A221502 protocol page located on the 
CTSU members’ website.  Permission to view and download this protocol and its supporting 
documents is restricted and is based on person and site roster assignment housed in the 
CTSU RSS. 
• 
Go to
 and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on the Protocols tab in the upper left of your screen 

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• 
Either enter the protocol # in the search field at the top of the protocol tree, or 
• 
Click on the By Lead Organization folder to expand  
• 
Click on the Alliance link to expand, then select trial protocol # A221502. 
• 
Click on LPO Documents, select the Site Registration documents link, and download 
and complete the forms provided.   
4.3.2  Requirements For A221502 Site Registration: 
• 
IRB approval (For sites not participating via the NCI CIRB; local IRB documentation, 
an IRB-signed CTSU IRB Certification Form, Protocol of Human Subjects Assurance 
Identification/IRB Certification/Declaration of Exemption Form, or combination is 
accepted ) 
• 
Approval of Site personnel training received from Dr. Benzo’s staff, as described in 
Section 5.2.2. 
4.3.3 Submitting Regulatory Requirements 
Submit required forms and documents to the CTSU Regulatory Office via the Regulatory 
Submission Portal, where they will be entered and tracked in the CTSU RSS.  
 
Regulatory Submission Portal: 
  (members’ area)  Regulatory Tab 
Regulatory Submission  
When applicable, original documents should be mailed to: 
CTSU Regulatory Office 
      
 
      
 
Institutions with patients waiting that are unable to use the Portal should alert the CTSU 
Regulatory Office immediately at 
 in order to receive further instruction and 
support. 
4.3.4 Checking Your Site’s Registration Status 
You can verify your site registration status on the members’ section of the CTSU website.   
 
Go to
 and log in to the members’ area using your CTEP-IAM 
username and password 
 
Click on the Regulatory tab  
 
Click on the Site Registration tab 
 
Enter your 5-character CTEP Institution Code and click on Go 
Note: The status given only reflects compliance with IRB documentation and institutional 
compliance with protocol-specific requirements outlined by the Lead Network. It does not 
reflect compliance with protocol requirements for individuals participating on the protocol 
or the enrolling investigator’s status with the NCI or their affiliated networks. 
4.3.5 Credentialing 
This is a limited access study. Each participating site must be individually approved by the 
study chair or designate and be listed as a participating institution on the cover page of the 
protocol. All participating sites will be approved by the study chair prior to being listed on 
the protocol cover page. See also Section 5.0. 

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The confirmation of site participation eligibility by the study chair is required before any 
patients may be enrolled on this study.  
Patients may not be registered to this study until at least one person from the site has been 
approved to perform pulmonary rehabilitation. Training should start at least a month 
prior to enrollment. It is recommended that each site have a trained backup person to cover 
absences. 
See Section 5.0 for full instructions regarding the training requirements.   
4.4 
Patient Registration Requirements 
Registration is to take place after surgery is scheduled. 
Informed consent:  
The patient must be aware of the neoplastic nature of his/her disease and willingly consent after 
being informed of the intervention, the experimental nature of the intervention, alternatives, 
potential benefits, and discomforts. Current human protection committee approval of this 
protocol and a consent form is required prior to patient consent and registration. Patients may 
be enrolled in other clinical trials while participating in this study. 
Patient Completed Booklets and Other Patient Materials: 
Patient questionnaire booklets to be administered at baseline are to be ordered prior to the 
registration of any patients. Patient completed booklets can be ordered by downloading and 
completing the booklet order form (located under the supplemental documents section of the 
A221502 web site) and faxing the form to Attn: Operational Support Clerk at 
. 
Samples of the booklets are found in Appendices I and II, which are to be used for reference and 
IRB submission only. They are not to be used for patient completion. 
The patient materials listed in section 5.4 must also be ordered prior to registration of any 
patients. Instructions for ordering these materials are provided in section 5.4. 
Patient Release of Medical Records:  
Medical records from admission to discharge must be submitted per Section 5.5. Patients must 
complete the institution’s own Authorization for Release of Medical Records prior to 
registration. 
Limited access information: 
This is a limited access study. Each participating Alliance member site must be individually 
approved by the study chair or designate and be listed as a participating site on the cover page 
of the protocol. All participating sites will be approved by the study chair prior to being listed 
on the protocol cover page. 
To become a participating site, please email 
 at 
. Please 
include the names of the institution, CTEP Institution ID, Surgeon(s), PR Specialist(s) and 
Institutional Coordinator.  See Section 5.2. 
4.5 
Patient Registration/Randomization Procedures. 
Patient enrollment will be facilitated using the Oncology Patient Enrollment Network (OPEN).  
OPEN is a web-based registration system available on a 24/7 basis.  To access OPEN, the site 
user 
must 
have 
an 
active 
CTEP-IAM 
account 
(check 
at 
) and a 'Registrar' role on either the LPO or participating 
organization roster. 

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All site staff will use OPEN to enroll patients to this study.  It is integrated with the CTSU 
Enterprise System for regulatory and roster data and, upon enrollment, initializes the patient in 
the Rave database. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the 
CTSU members’ side of the website at 
 A user manual is available for 
OPEN users on the CTSU site. 
Prior to accessing OPEN, site staff should verify the following: 
• 
All eligibility criteria have been met within the protocol stated timeframes.  
• 
All patients have signed an appropriate consent form and HIPAA authorization form (if 
applicable). 
Note: The OPEN system will provide the site with a printable confirmation of registration and 
treatment information. Please print this confirmation for your records. 
Further instructional information is provided on the OPEN tab of the CTSU members’ side of 
the CTSU website at 
 or at 
.  For any additional 
questions contact the CTSU Help Desk at 
 or 
. 
4.6  
Stratification Factors 
Randomization will be stratified (equal number in both groups) by 3 variables that may bias the 
results if they become unbalanced after randomization:  
4.6.1 Very severe lung function defined as one of the following: (FEV1 <30% predicted) or use 
of permanent oxygen or PCO2 >50mmgh]) 
Yes vs. No 
NOTE: If the patient has no lung function test it will be considered NOT very severe lung 
function. 
4.6.2  Prior Neo-adjuvant chemotherapy for this operation   
Yes vs. No 
4.6.3  Open thoracotomy vs. video assisted thoracoscopy (VATS).  
5.0 
STUDY IMPLEMENTATION 
5.1 
PR Clinic Requirements 
It is not required that sites have a pulmonary rehabilitation program. Institutional staff will be 
trained to lead the rehabilitation techniques used in the study. 
5.2 
PR Manual and Training Requirements 
5.2.1 General Requirements 
• 
The individuals to be trained at each institution are those who have experience dealing 
with patients with chronic lung conditions.  
• 
Institutions must name a physician, who could be a thoracic surgeon or thoracic 
pulmonologist to oversee the staff doing the intervention. 
• 
The participating sites must have a space that is dedicated to the intervention. An 
appropriate space allows the patients to do the walking and movement exercises with 
the appointed trainer without disturbance.  

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5.2.2 Training of the Site Personnel for Pulmonary Rehabilitation 
Patients may not be registered to this study until at least one person from each site has been 
approved to perform pulmonary rehabilitation. It is recommended that each site have a 
trained backup person to cover absences. 
This study requires that the person who will deliver the intervention is approved by Dr. 
Benzo’s staff. Each person who administers the intervention must be certified. 
Each participating site will have one or two people who are trained to deliver the 
intervention (nurse, respiratory therapist or physiotherapist, or trained study coordinator).  
Training should start at least a month prior to enrollment. It is anticipated that the one 
on one training will require four 30 minute calls with homework in between. 
Dr. Benzo’s staff will train the PR staff or selected interventionist for the delivery of the 
intervention. Training documents and videos will be sent to the participating site by Dr. 
Benzo’s staff. Institutional staff who will be delivering the intervention will have 
demonstrated an understanding of the content of these materials.  These interventionists will 
be trained in steps, which will include reviewing materials and demonstrating proficiency 
in leading the patient through the techniques. After the individual is comfortable with the 
intervention protocol s/he is to demonstrate the exercises while being recorded (cellphone, 
video camera). The recording can be sent to 
 Once the recording 
has been reviewed, the individual will have a one-on-one online training via Skype or 
FaceTime with Dr. Benzo’s staff. Once it has been determined that the individual is able to 
deliver the intervention, Dr. Benzo’s staff will email notice of this approval (in the form of 
a “confirmation of certification form”) to the site, which will need to submit this approval 
to the CTSU per sections 4.3.2 and 4.3.3.  
5.3 
Patient Recruitment 
Potential participants should not be approached for this study until it is determined that 
they are eligible for surgery. 
Surgeons will schedule the patient’s surgery in a period not sooner than 3 weeks from the 
surgical consultation to allow time for the intervention or the control-group walking practice (3 
weeks is the typical wait time for most centers and does not affect the outcome of  the lung 
cancer). The patient will be offered the study after the date is set.   
5.4 
Patient materials 
The following materials, which will be provided to patients following registration, must be 
ordered from 
 by emailing her at: 
.  
Intervention arm 
Control Arm 
Participant Manual 
Pedometer 
Patient Log 
Patient Log 
DVD of pulmonary rehabilitation 
Exercise Pamphlet 
CD/audio recording with breathing exercises 
 
PFlex device 
 
Note: In addition to the patient materials listed above, pre-stamped envelopes for submission of 
patient logs and booklets will be included with the packet.  
 

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5.5 
Study Calendar 
 
Baseline 
During 2 weeks 
 of PR  
After Hospital 
Discharge 
At 3 and 6 months 
after surgery* 
MRC Dyspnea scale  
X 
 
 
X 
CRQ 
X 
 
 
X 
LASA 
X 
 
 
X 
Patient Log 
 
X(1) 
 
 
CRA Contact 
 
 
X(2) 
X(4) 
Hospital records 
 
 
X(3) 
 
* 
A window of +/- 2 weeks before or after each time point for completion of the self-report 
measures will be allowed. The nurse/CRA should call the patient prior to mailing the 
questionnaire booklets. The call is to let the patient know that the questionnaires are on the 
way. 
1 
Patients on the intervention arm will return the completed log to local site staff at the end of 
the final PR visit. Patients on the control arm will be asked to mail completed patient logs 
to local site staff. Sites will then mail all patient logs to the address provided in Section 6.3.  
2 
The CRA will call the patient within 7 days from discharge to ask the 3 questions included 
in Appendix III.  
3 
Hospital records MUST include inpatient information from admissions to discharge. See 
Section 6.3. 
4 
The CRA will call the patient to let the patient know that the questionnaires are on the way. 
6.0 
DATA SUBMISSION  
6.1 
Data Collection and Submission 
Data collection for this study will be done exclusively through the Medidata Rave clinical data 
management system. Access to the trial in Rave is granted through the iMedidata application to 
all persons with the appropriate roles assigned in Regulatory Support System (RSS). To access 
Rave via iMedidata, the site user must have an active CTEP-IAM account (check at 
) and the appropriate Rave role (Rave CRA, Read-
Only, Site Investigator) on either the LPO or participating organization roster at the enrolling 
site. 
Upon initial site registration approval for the study in RSS, all persons with Rave roles assigned 
on the appropriate roster will be sent a study invitation e-mail from iMedidata. To accept the 
invitation, site users must log into the Select Login 
 
using their CTEP-IAM user name and password, and click on the “accept” link in the upper 
right-corner of the iMedidata page. Please note, site users will not be able to access the study in 
Rave until all required Medidata and study specific trainings are completed. Trainings will be 
in the form of electronic learnings (eLearnings), and can be accessed by clicking on the link in 
the upper right pane of the iMedidata screen. 
Users who have not previously activated their iMedidata/Rave account at the time of initial site 
registration approval for the study in RSS will also receive a separate invitation from iMedidata 
to activate their account. Account activation instructions are located on the CTSU website, Rave 
tab under the Rave resource materials (Medidata Account Activation and Study Invitation 
Acceptance). Additional information on iMedidata/Rave is available on the CTSU members’ 

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website under the Rave tab at 
 or by contacting the CTSU Help Desk at 
 or by e-mail at 
.   
A Schedule of Forms is available on the Alliance study webpage, within the Case Report Forms 
section.  
6.2 
Patient questionnaire booklets 
All patient questionnaire booklets for A221502 are to be ordered prior to the registration 
of any patients. Baseline booklets will be administered in clinic at the time that the patient is 
randomized. Samples of all questionnaire/booklets are available in Appendices I and II, for 
reference and IRB submission only. They are not to be used for patient completion.  
Post-surgery booklets (month 3 and month 6) should be mailed by institutional staff to patients 
1 week before the 3 and 6 month time points. Patients will be instructed to mail the booklets 
back to their registering site for entry into the iMedidata RAVE.  
6.3 
Hospital records 
Submission of hospital records listed in Appendix IV will be required. Dates of admission, 
surgery and discharge must be included with these records. Hospital records must be de-
identified by institutional staff before mailing to Dr. Benzo’s staff. Site personnel MUST remove 
all protected health information (PHI) from the medical records (including but not limited to): 
- 
Patient name 
- 
Patient initials 
- 
Date of birth 
- 
Phone numbers 
- 
Social security number 
- 
Medical record number or account number 
- 
Any unique identifying number, characteristic or code 
The Alliance patient ID number must be included on each page. De-identified hospital records 
should be mailed to: 
 
 
 
Dr. Benzo’s staff will provide participating sites with pre-addressed postage paid envelopes. 
 
 

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7.0 
STUDY INTERVENTION 
 
 
Baseline 
 
Over 2 weeks, before surgery 
 
Within 3 weeks 
after 
registration 
 
At 3 and 6 
months after 
discharge 
 
 
 
 
 
 
 
 
 
 
 
Intervention: 10 in-clinic sessions of 
preoperative Pulmonary Rehabilitation 
 
 
 
 
 
 
 
 
 
 
 
 
Schedule 
Surgery 
 
Random- 
ization 
 
 
Surgery 
 
Follow-up 
Questionnaires 
 
 
 
 
 
 
 
Control: Standard care of preoperative 
preparation plus activity incentive 
pedometer/exercise routine 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.1 
Intervention group procedures 
Patients who are randomized to the intervention group will start the Pulmonary Rehabilitation 
(PR) within 7 days after randomization. The PR will consist of 10 sessions with the 
interventionist lasting less than 2 hours each. Patients will receive a Participant Manual 
demonstrating and explaining the rehabilitation process.  Patients will also receive a log for 
recording their efforts and notes for every day until the day of surgery. We will consider 6 
sessions as the minimum to be deemed a complete intervention (for analysis purposes).  The 
patients should not be asked to come only 6 times to the clinic. In case of missing sessions, the 
patient should be encouraged to do the sessions at home, however, they will not be counted as 
intervention sessions.    
Using the video recording during Pulmonary Rehabilitation sessions:  
A video recording of the intervention from start to finish will be provided to all patients in the 
intervention arm. The recording will be an mp3 file that can be played from any device (e.g., 
phone, computer). Alternatively a CD that has the breathing practice may be used. Patients may 
keep the DVD/CD. The DVD should be used during the intervention with the participant.  The 
patient and interventionist should both follow the video.  This ensures that the same intervention 
is being delivered.   
The video recording should be played in all 10 sessions at the registering site. Following the 
video recording will add uniformity to the intervention across sites. The interventionist can stop 
the video recording any time during the session to give instructions or answer questions.  
Modifications may be made if needed.  For example, if the patient has shoulder injury and cannot 
lift arms over head, then the exercise may be modified to accommodate the patient.   
PR sessions will include the following components: 
The patient will document in a log that they completed each component of the rehabilitation. 
The patients will be asked to return the log to the registering site at the end of their last PR 
session.   
7.1.1  Breathing Awareness (in clinic): Before and after each session, the patient will do a 3-
minute mindful breathing awareness exercise guided by an audio recording provided either 
as a CD or mp3 file. We provided also an ultra-short 10 Breath Practice that can be used 
during the day and at times when there are worsening symptoms (i.e. pain after surgery). 
7.1.2 Upper and lower extremity exercise (in clinic): Strength and stretching exercises (goal of 
at least 20 minutes per session), treadmill or hallway walking (preferred) with a goal of total 
24 minutes per session (not less than 18 minutes). The sites and patients will be provided a 
DVD that demonstrates the rehabilitation session from start to finish.   

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It is acknowledged that it could be “boring to have a recording” or follow a movie every 
time but that will provide consistency of the intervention across sites.  Patients are expected 
to engage in walking once daily and complete the IMT routine and upper extremity 
exercises. 
7.1.3 Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve 
(Philips Healthcare Andover, MA) (in clinic): Patients will be instructed to inhale deeply 
and forcefully for 2 seconds and exhale normally. Repeat for one minute and rest for 30 
seconds for a total of 10 complete cycles (training plus resting time). Patients are asked to 
adjust their trainer (there is a selector with different levels of effort) to a level of perceived 
exertion of “Somewhat Hard to Hard” (11-13 on the 6-20 BORG scale) when they breathe 
through the device. When patients note perceived exertion less than “Somewhat Hard”, the 
next IMT setting is increased to achieve the desired effort. The rationale to include routine 
use of inspiratory muscle training, not recommended as a routine in the current PR 
guidelines, is based primarily on a recent large randomized study which showed decreased 
postoperative complications.20-22  
The table below lists the exercises that are part of the PR sessions.  
Exercise 
Time  
Description 
Breathing Awareness 
3 Minutes 
3 minute breathing practice at start of session 
Upper Extremity 
20 Minutes 
Neck, Shoulder, Arm Movements 
Lower Extremity 
18-24 Minutes 
Goal is 4 six Minute Walks, but not less than 3 
P-Flex 
15 Minutes 
10 one minute repetitions with 30 second breaks in-between 
Breathing Awareness 
10 Breaths 
10 Breath practice at end of session 
 
7.1.4  Practice at home: 
One-on-one revision of the IMT technique will be completed every session in the lab, and 
patients will be asked to do 10 repetitions of IMT twice a day when not in the lab, which 
includes the weekend. Twice a day training is the minimum required. 
Upper and lower extremity training:  Once a day training of one set of ten repetitions of 
upper extremity exercises, and two 6 minute walks in a safe place in the home is the 
minimum required. 
This is a critical step in the process.  Patients will be encouraged to practice every day and 
record their practice into a log that will be reviewed by the interventionist every session. 
7.1.5  Goal setting 
The patients are encouraged to set goals, a post-operative goal and post hospital discharge 
goal. The patients do not record the goals. 
Post-operative goals will be to do at least one six minute walk, one upper arm series every 
day while still in the hospital. Patients will also be asked to set a goal to practice the 
breathing awareness, ten breaths, at least two times a day, particularly when in pain or 
stressed.  
Post hospital discharge goals the same as post-operative goals.  
7.2 
Control Group Procedures 
Patients randomized to the control arm will receive a pedometer to monitor their daily steps and 
a pamphlet with exercises plus the standard course of care for patients undergoing lung resection 

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surgery. The patients will not be asked to return the pedometer.  The local institutional 
coordinator (not the rehabilitation interventionist) will go over the use of the pedometer and the 
exercise materials with the patient. The patients will be asked to keep a log of their pre-operative 
steps and mail the log to the registering site.  The pedometers will be provided to the site prior 
to enrollment. 
8.0 
ADVERSE EVENTS 
We do not anticipate any adverse events related to participation in this study. PR has no reported risks 
based on 3000 patients with severe COPD in the National Emphysema treatment trial that underwent 
exercise training in more intensity compared to the one planned in this study.23 
9.0 
MEASURES 
9.1 
Chronic Respiratory Questionnaire (CRQ):  
A 20-question inventory assessing the areas of dyspnea, fatigue, emotion, and feelings of 
mastery. The fatigue, emotion, and mastery subscales ask the patient to rate how often in the last 
two weeks they have been afflicted with a particular feeling or experience on a scale of 1 to 7, 
with higher ratings indicating less symptom impairment. The dyspnea subscale gives an 
additional option of indicating that a particular activity has not been done.24-27 The CRQ takes 
approximately 10 minutes to complete. 
9.2 
MRC: Medical Research Council Dyspnea Score (MRC): 
 A 5 statement questionnaire where the patient selects the answer that most closely describes the 
level of physical activity that precipitates their shortness of breath. The highest selected 
statement (more severe) is the score. The MRC Dyspnea Scale takes less than 5 minutes to 
complete.  
9.3 
Linear Analog Self-Assessment (LASA):   
A 5 question inventory measuring well-being on a scale of 1 (as bad as it can be) to 10 (as good 
as it can be).  The LASA takes less than 5 minutes to complete. 
10.0 END OF INTERVENTION 
10.1 
Duration of Treatment  
Patients in the intervention group will be scheduled for 10 sessions of mindful rehabilitation.  
Six sessions is the minimum requirement. Patients will be followed until 6 months following 
surgery.  
10.2 
Managing ineligible patients and registered patients who never receive protocol 
intervention  
Definition of ineligible patient: A study participant who is registered to the trial but does not 
meet all of the eligibility criteria is deemed to be ineligible.  
Follow-up for ineligible patients who continue with protocol treatment 
Patients who are deemed ineligible after registering may continue protocol intervention, 
provided the treating physician, study chair, and executive officer agree there are no safety 
concerns if the patient continues protocol intervention. All scans, tests, and data submission are 
to continue as if the patient were eligible. Notification of the local IRB may be necessary per 
local IRB policies. 

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Follow-up for ineligible patients who discontinue protocol treatment 
For patients who are deemed ineligible after registering to the trial, who start treatment, but then 
discontinue study treatment, the same data submission requirements are to be followed as for 
those patients who are eligible and who discontinue study treatment. 
Follow-up for patients who are registered, but who never start study treatment 
If surgery is cancelled after registration, the participant will be considered a screen failure. 
For all study participants who are registered to the trial but who never receive study intervention 
(regardless of eligibility), baseline and off-treatment notice data submission is required. See the 
Data Submission Schedule accompanying the All Forms Packet. 
11.0 STATISTICAL CONSIDERATIONS 
11.1 
Study Overview 
Prospectively, 194 patients will be randomized to either ten sessions of preoperative pulmonary 
rehabilitation vs. standard care at a number of healthcare centers throughout the United States.  
11.2 
Sample Size, Accrual Time, and Study Duration 
11.2.1  Sample Size 
A total of 194 patients (97 in each group) will be accrued to this study. This sample size 
includes a 10% adjustment to account for attrition and will provide at least 80% power for 
testing each aim of the study. Based on estimates from the pilot study, this sample size will 
provide 80% power to detect a 25% difference in complication rates, a 3-day difference in 
chest tube days, 3 day difference in length of stay, and a half standard deviation difference 
in QOL endpoints. 
11.2.2 Accrual Rate and Accrual Duration 
This study will be open for 36 months.  We expect to close the study to accrual at month 30 
to allow time for statistical analysis and publication.  About 7 patients a month need to be 
recruited to meet the 30 month proposed time line. 
11.2.3  Primary Endpoint Completion Date for ClinicalTrials.gov Reporting 
For purposes of ClinicalTrials.gov reporting, the Primary Endpoint Completion Date 
(PECD) for this study is the time the last patient registered has been followed for at least 6 
months. 
11.3 
Statistical Design and Analysis for the Primary Endpoint 
11.3.1  Primary Endpoint 
End point that will address AIM 1: hospital length of stay. The coordinator at each site will 
be responsible for sending complete de-identified hospital records from each patient to Dr. 
Benzo’s staff, where a nurse blinded to the study arm will abstract the main outcome (length 
of stay and postoperative complications).  See Section 6.3. 
The primary endpoint will be assessed at Dr. Benzo’s office (Mayo Clinic) with the 
complete admission hospital records in order to extract the length of stay. The records will 
be mailed from the sites to 
 in a pre-stamped envelope. See Section 6.3. 
11.3.2  Analysis Plan 

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Differences in length of stay between arms will be tested using a two-sample, two-sided t-
test. Wilcoxon nonparametric testing will be used for analyzing continuous outcomes that 
are skewed and not approximately normally distributed. Fisher’s exact tests will be used to 
test for differences in categorical variables between arms. All tests will be two-sided with a 
0.05 significance level. Linear models will be created to test the effects of treatment after 
adjusting for the baseline characteristics of age, gender, and lung function. 
11.4 
Supplementary Analysis Plans 
11.4.1  Secondary Endpoints 
End points that will address AIM 2 (baseline and at 3 and 6 months after hospital discharge):  
Post-Operative Pulmonary Complications: The following events will be considered post-
operative pulmonary complications: pneumonia (new infiltrate + either fever (>38.5 C) and 
white cell count >11,000 or fever and purulent secretions), severe atelectasis (requiring 
bronchoscopy), prolonged chest tubes (>6 days), and respiratory failure (intubation or 
prolonged mechanical ventilation (>24 hours).  These outcomes will be obtained by chart 
review by a nurse trained in the abstraction of the desired outcomes from the medical records 
and blinded to treatment assignment. 
 
Chronic Respiratory Questionnaire (CRQ) (four domains: dyspnea, fatigue, emotional 
function and mastery). This instrument will be the primary tool to assess QoL given that it 
was specifically designed for COPD. Specifically, the CRQ represents one of the most well-
known, widely-applied, and psychometrically-sound patient reported outcomes for use in 
clinical trials involving patients with COPD. The CRQ has been validated and has 
demonstrated a reliable quality of life measures for patients with chronic airflow limitations. 
.A 0.5 point will be considered significant and was considered in the sample size calculation 
as that difference as is the well-established MCID (minimally clinically important 
difference) for the instrument.  Analysis for the QOL outcomes will be identical to that for 
the primary endpoint. We include the scores from the dyspnea questionnaire under the 
generic umbrella term as a domain of QOL. 
LASA (single-item numerical analogue quality of life Questionnaire) individual QOL 
domain scores.  All of these questionnaires have been validated previously for lung cancer 
patient populations and for assessment of patient-reported outcomes in similar trials.  LASA 
items have been validated as general measures of global QOL dimensional constructs in 
numerous settings and have been constructed and validated at Mayo Clinic for use in cancer 
patients. These single-item assessments have become the most used assessments in all NCI-
sponsored cancer control studies.28 
11.4.2  Secondary Analysis 
 
Longitudinal analysis for the relationship between QOL and the intervention will be handled 
by repeated measures analysis of variance modeling and multiple regressions. Finally, a 
logistic regression model will be used to identify which variables are most closely associated 
with the dependent variable of patients who experience either clinically significant deficits 
in QOL (one regression model). The modeling processes will include the aforementioned 
covariates to control for spurious correlations. 
 
 

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11.5 
Study Monitoring 
11.5.1  Adverse Event Stopping Rule 
Not applicable.  
11.5.2  Accrual Monitoring Stopping Rule 
Slow Accrual: Patient accrual will be closely monitored by the investigators and secondary 
statistician on a monthly basis. If the accrual rate falls below 50% of expected accrual rate, 
investigators will carefully review feedback from sites and consider taking measures to 
encourage patient enrollment. 
11.5.3  This study will be monitored by the Alliance Data Safety Monitoring Board (DSMB), an 
NCI-approved functioning body. Reports containing efficacy, adverse event, and 
administrative information will be provided to the DSMB every month as per NCI 
guidelines. 
11.6 
Study Reporting 
At study activation, this study will have been registered within the “ClinicialTrials.gov” web 
site. The Primary and Secondary Endpoints (i.e., “Outcome Measures”) along with other 
required information for this study will be reported on ClinicalTrials.gov.  
11.7 
Descriptive Factors  
None. 
11.8 
Inclusion of Women and Minorities 
Inclusion of Women: Based upon the gender distribution of patients from past studies and the 
gender distribution with ICD-9 codes for COPD/ lung cancer, we anticipate a female to male 
ratio of 5/6 ratio. 
DOMESTIC PLANNED ENROLLMENT REPORT 
Racial Categories 
Ethnic Categories 
Total 
Not Hispanic or 
Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American Indian/ Alaska Native 
1 
1 
0 
0 
2 
Asian 
5 
3 
1 
1 
10 
Native Hawaiian or Other Pacific 
Islander 
1 
1 
0 
0 
2 
Black or African American 
14 
9 
1 
1 
25 
White 
80 
57 
4 
4 
145 
More Than One Race 
4 
3 
2 
1 
10 
Total 
105 
74 
8 
7 
194 
 
 

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12.0 REFERENCES 
1. 
Wang, J., et al., Assessment of pulmonary complications after lung resection. Ann Thorac Surg, 
1999. 67(5): p. 1444-7. 
2. 
Raviv, S., et al., Lung cancer in chronic obstructive pulmonary disease: enhancing surgical options 
and outcomes. Am J Respir Crit Care Med, 2011. 183(9): p. 1138-46. 
3. 
Brunelli, A., et al., The European Respiratory Society and European Society of Thoracic Surgeons 
clinical guidelines for evaluating fitness for radical treatment (surgery and chemoradiotherapy) in patients 
with lung cancer: Eur J Cardiothorac Surg. 2009 Jul;36(1):181-4. doi: 10.1016/j.ejcts.2009.04.022. Epub 
2009 May 27. 
4. 
Takaoka, S.T. and A.B. Weinacker, The value of preoperative pulmonary rehabilitation. Thorac 
Surg Clin, 2005. 15(2): p. 203-11. 
5. 
Nici, L., Preoperative and postoperative pulmonary rehabilitation in lung cancer patients. Thorac 
Surg Clin, 2008. 18(1): p. 39-43. 
6. 
Shannon, V.R., Role of pulmonary rehabilitation in the management of patients with lung cancer. 
Curr Opin Pulm Med, 2010. 16(4): p. 334-9. 
7. 
Benzo, R.P., Pulmonary rehabilitation in lung cancer: a scientific opportunity. J Cardiopulm 
Rehabil Prev, 2007. 27(2): p. 61-4. 
8. 
Wilson, D.J., Pulmonary rehabilitation exercise program for high-risk thoracic surgical patients. 
Chest Surg Clin N Am, 1997. 7(4): p. 697-706. 
9. 
Rodriguez-Larrad, A., et al., Perioperative physiotherapy in patients undergoing lung cancer 
resection. Interact Cardiovasc Thorac Surg, 2014. 19(2): p. 269-81. 
10. 
Rivas-Perez, H. and P. Nana-Sinkam, Integrating pulmonary rehabilitation into the 
multidisciplinary management of lung cancer: a review. Respir Med, 2015. 109(4): p. 437-42. 
11. 
Temel, J.S., et al., Early palliative care for patients with metastatic non-small-cell lung cancer. N 
Engl J Med, 2010. 363(8): p. 733-42. 
12. 
Movsas, B., et al., Quality of life supersedes the classic prognosticators for long-term survival in 
locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. J Clin Oncol, 2009. 27(34): p. 
5816-22. 
13. 
Montazeri, A., Quality of life data as prognostic indicators of survival in cancer patients: an 
overview of the literature from 1982 to 2008. Health Qual Life Outcomes, 2009. 7(102): p. 1477-7525. 
14. 
Degner, L.F. and J.A. Sloan, Symptom distress in newly diagnosed ambulatory cancer patients and 
as a predictor of survival in lung cancer. J Pain Symptom Manage, 1995. 10(6): p. 423-31. 
15. 
Huschka, M.M., et al., A pooled analysis of quality of life measures and adverse events data in 
north central cancer treatment group lung cancer clinical trials: Cancer. 2007 Feb 15; 109(4):787-95. 
16. 
Qi, Y., et al., Pretreatment quality of life is an independent prognostic factor for overall survival in 
patients with advanced stage non-small cell lung cancer. J Thorac Oncol, 2009. 4(9): p. 1075-82. 
17. 
Coups, E.J., et al., Physical activity among lung cancer survivors: changes across the cancer 
trajectory and associations with quality of life. Cancer Epidemiol Biomarkers Prev, 2009. 18(2): p. 664-72. 
18. 
Handy, J.R., Jr., et al., What happens to patients undergoing lung cancer surgery? Outcomes and 
quality of life before and after surgery. Chest, 2002. 122(1): p. 21-30. 
19. 
Pompili, C., et al., Predictors of postoperative decline in quality of life after major lung resections. 
Eur J Cardiothorac Surg, 2011. 39(5): p. 732-7. 
20. 
Yanez-Brage, I., et al., Respiratory physiotherapy and incidence of pulmonary complications in 
off-pump coronary artery bypass graft surgery: an observational follow-up study. BMC Pulm Med, 2009. 
9(36): p. 1471-2466. 
21. 
van Weert, E., et al., The development of an evidence-based physical self-management 
rehabilitation programme for cancer survivors. Patient Educ Couns, 2008. 71(2): p. 169-90. 
22. 
Brocki, B.C., et al., Postoperative inspiratory muscle training in addition to breathing exercises and 
early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized 
controlled trial. Eur J Cardiothorac Surg, 2015. 20.  

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23.  
A, F., et al., A randomized trial comparing lung-volume-reduction surgery with medical therapy 
for severe emphysema. N Engl J Med, 2003. 348(21): p. 2059-73. 
24.  
Oga T, Nishimura K, Tsukino M, Sato S, Hajiro T, Ikeda A, Mishima M. Health status measured 
with the crq does not predict mortality in copd. Eur Respir J 2002;20:1147-1151. 
25. 
Williams JE, Singh SJ, Sewell L, Guyatt GH, Morgan MD. Development of a self-reported 
chronic respiratory questionnaire (crq-sr). Thorax 2001;56:954-959. 
26. 
Schunemann HJ, Goldstein R, Mador MJ, et al. A randomised trial to evaluate the self-
administered standardised chronic respiratory questionnaire. The European respiratory journal. Jan 
2005;25(1):31-40. 
27. 
Schunemann HJ, Griffith L, Jaeschke R, et al. A comparison of the original chronic respiratory 
questionnaire with a standardized version. Chest. Oct 2003;124(4):1421-1429. 
28.  
Locke DEC, Decker PA, Sloan JA, et al. Validation of Single-Item Linear Analog Scale 
Assessment of Quality of Life in Neuro-Oncology Patients. Journal of pain and symptom management. 
2007;34(6):628-638. doi:10.1016/j.jpainsymman.2007.01.016. 
 
 

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13.0 MODEL CONSENT FORM 
 
Study Title for Study Participants: 
Alliance A221502:  Breathing Exercises Before Lung Cancer Surgery  
 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: 
Pulmonary Rehabilitation before Lung Cancer Resection 
This research study is conducted by the Alliance for Clinical Trials in Oncology, a national clinical 
research group supported by the National Cancer Institute. The Alliance is made up of cancer 
doctors, health professionals, and laboratory researchers, whose goal is to develop better 
treatments for cancer, to prevent cancer, to reduce side effects from cancer, and to improve the 
quality of life of cancer patients. 
What is the usual approach to preparing for lung cancer surgery? 
You are being asked to take part in this study because you have or are suspected of having non-
small cell lung cancer (NSCLC) and Chronic Obstructive Pulmonary Disease (COPD) and your 
doctor is recommending surgery.  Lung cancer surgery for people with COPD can cause 
complications such as pneumonia and prolonged hospital stays. Asking patients to quit smoking 
is the usual approach to prepare patients for lung cancer surgery.  
What are my other choices if I do not take part in this study? 
If you decide not to take part in this study, you have other choices. For example: 
• 
You may choose to not do anything prior to surgery 
• 
You may choose to take part in a different study, if one is available 
Why is this study being done? 
You will have surgery to remove your lung cancer. The purpose of this study is to test whether a 
breathing exercise program before lung resection is helpful on the recovery from surgery in 
patients with NSCLC and COPD. The effects of the pulmonary rehabilitation will be compared 
to usual approach. 
There will be about 194 people taking part in this study. 
 
 

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What are the study groups? 
This study has two study groups. 
• 
Group 1 will participate in ten pulmonary rehabilitation sessions at the clinic with 
additional exercises to be done at home. 
• 
Group 2 will receive a pedometer and exercise routine to use at home along with usual 
care 
A computer will by chance assign you to treatment groups in the study. This is called 
randomization. This is done by chance because no one knows if one study group is better or 
worse than the others. 
 
Before Surgery: 
Group 1: If you are in this group, you will receive ten sessions of pulmonary rehabilitation in 
clinic lasting a little less than two hours per session. You will be asked to complete a log of 
your activities during the pulmonary rehabilitation. Pulmonary rehabilitation will include the 
following components:  
• 
Upper and lower extremity (arms and legs) exercises 
• 
Inspiratory muscle training, which is breathing through a device to strengthen the 
breathing muscles 
• 
Slow breathing training using a CD or mp3 file  
You will also be asked to complete 3 brief questionnaires related to your health.  The 
questionnaires should take about 20 minutes to complete. 
If you experience any emotional discomfort when completing the questionnaires, you may 
choose not to complete them. You should tell your doctor if you are having any physical or 
psychological symptoms such as extreme sadness or physical pain related to your treatment.  
 
Group 2: If you are in this group, you will be asked to complete brief questionnaires related to 
your health.  The questionnaires take about 20 minutes to complete. You will also receive a 
pedometer to track your steps and a booklet demonstrating exercises for people who have 
undergone a lung surgery. You will be asked to complete a log of your activities during the two 
weeks prior to your surgery. 
 
 

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After Surgery: 
Group 1 and Group 2: You will be asked to complete brief questionnaires related to your 
physical activity and health after surgery, 3 months and 6 months after surgery.  The 
questionnaires take about 20 minutes to complete. 
Another way to find out what will happen to you during this study is to read the chart below. 
Start reading at the left side and read across to the right, following the lines and arrows. 
 
 
 
 
Pulmonary Rehabilitation: 10 
sessions in the clinic over two 
weeks 
 
 
 
 
 
 
 
 
 
 
 
 
You agree to 
take part in 
the study 
 
 
 
 
 
 
Complete 
questionnaires 
after 3 and 6 
months 
 
Randomize 
 
 
 
Surgery 
 
 
 
Usual care plus 
pedometer/exercise routine 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How long will I be in this study? 
You will participate either in the pulmonary rehabilitation or usual care for two weeks before 
your surgery. After your surgery, you will participate in this study for about 6 months. 
What possible risks can I expect from taking part in this study? 
If you choose to take part in this study, there is a risk that: 
• 
You may lose time at work or home and spend more time in the hospital or doctor’s office 
than usual 
• 
You may be asked sensitive or private questions which you normally do not discuss. You 
may choose not to answer any questions that make you feel uncomfortable. 
Here are important points about side effects: 
• 
The study doctors do not know who will or will not have side effects. 
• 
Some side effects may go away soon, some may last a long time, or some may never go 
away. 
Tell the study doctor if you notice or feel anything different so they can see if you are having a 
side effect. The study doctor may be able to treat some side effects. 
• 
While unlikely, you may experience muscle or joint pain due to increased exercise. 
• 
There is the risk of developing cardiac ischemia (chest pain) due to not enough oxygen 
going to the heart during exercise.  
What possible benefits can I expect from taking part in this study? 
This study may not make your health better.  By educating you on healthy behavior and 
promoting a more active lifestyle, the study team hopes you will see improvement in your health 
no matter the group to which are assigned. This study will help researchers learn things that will 
help people in the future. 

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Can I stop taking part in this study? 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let 
the study doctor know as soon as possible so you can stop safely. If you stop, you can decide 
whether or not to let the study doctor continue to provide your medical information to the 
organization running the study. 
The study doctor will tell you about new information or changes in the study that may affect 
your health or your willingness to continue in the study. 
The study doctor may take you out of the study: 
• 
If your health changes and the study is no longer in your best interest 
• 
If new information becomes available 
• 
If you do not follow the study rules 
• 
If the study is stopped by the sponsor, IRB or FDA. 
What are my rights in this study? 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you. You will not lose medical care or any legal 
rights. 
For questions about your rights while in this study, call the ________________________ (insert 
name of center) Institutional Review Board at __________________ (insert telephone number). 
(Note to Local Investigator: Contact information for patient representatives or other individuals 
at a local institution who are not on the IRB or research team but take calls regarding clinical 
trial questions can also be listed here.) 
What are the costs of taking part in this study? 
The pulmonary rehabilitation (for Group 1 participants) and pedometer (for Group 2 participants) 
will be provided at no charge while you take part in this study.  
You and/or your health plan/insurance company will need to pay for all of the other costs of 
treating your cancer while in this study, including the cost of tests, procedures, or medicines to 
manage any side effects, unless you are told that certain tests are supplied at no charge. Before 
you decide to be in the study, you should check with your health plan or insurance company to 
find out exactly what they will pay for. 
You will not be paid for taking part in this study. 
What happens if I am injured or hurt because I took part in this study? 
If you are injured or hurt as a result of taking part in this study and need medical treatment, 
please tell your study doctor. The study sponsors will not offer to pay for medical treatment for 
injury. Your insurance company may not be willing to pay for study-related injury. If you have 
no insurance, you would be responsible for any costs. 

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If you feel this injury was a result of medical error, you keep all your legal rights to receive 
payment for this even though you are in a study. 
Who will see my medical information? 
Your health care provider will mail a copy of your hospital records from the time you were 
admitted for your surgery until you are discharged. This will include X-ray reports, lab results, 
progress notes, operative report, discharge summary and the dates when they occur.  These 
records will be sent to Alliance researchers at the Mayo Clinic where a care provider will review 
the records for length of stay and any complication you may have.  You may be asked to sign a 
form that will allow your health care provider to send these records. 
Your privacy is very important to us and the researchers will make every effort to protect it. 
Your information may be given out if required by law. For example, certain states require 
doctors to report to health boards if they find a disease like tuberculosis. However, the 
researchers will do their best to make sure that any information that is released will not identify 
you. Some of your health information from this study will be kept in a central database for 
research. Your name or contact information will not be put in the database. 
There are organizations that may inspect your records. These organizations are required to make 
sure your information is kept private, unless required by law to provide information. Some of 
these organizations are: 
• 
The Alliance for Clinical Trials in Oncology 
• 
The Institutional Review Board, IRB, is a group of people who review the research with 
the goal of protecting the people who take part in the study. 
• 
The Food and Drug Administration and the National Cancer Institute in the U.S., and 
similar ones if other countries are involved in the study. 
Where can I get more information? 
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or 
general information about cancer. You may also call the NCI Cancer Information Service to get 
the same information at: 1-800-4-CANCER (1-800-422-6237). 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
Who can answer my questions about this study? 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor __________________ (insert name of 
study doctor[s]) at __________________ (insert telephone number). 

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My Signature Agreeing to Take Part in the Study 
I have read this consent form or had it read to me. I have discussed it with the study doctor and 
my questions have been answered. I will be given a signed copy of this form. I agree to take part 
in the study.  
 
You must be willing to attend 10 sessions over two weeks of pulmonary rehabilitation if you are 
randomized to Group 1. 
 
Participant’s signature________________________________ 
 
Date of signature_____________________________________ 
 
 
 

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APPENDIX I 
 
 

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LINEAR ANALOGUE SELF ASSESSMENT 
 
Directions: Please circle the number (0-10) best reflecting your response to the following 
that describes your feelings during the past week, including today. 
How would you describe: 
 
1. Your overall Quality of Life? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
2. Your overall mental (intellectual) well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
3. Your overall physical well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
4. Your overall emotional well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
5. Your level of social activity? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
6. Your overall spiritual well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 

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Medical Research Council (MRC) Breathlessness Scale 
 
INSTRUCTIONS: Please read each statement carefully.  If you agree with the statement please circle 
YES.  If you disagree with the statement please circle NO.  Please be sure to answer all the questions.  
Only circle 1 answer for each question.  If you make a mistake, place an X over the incorrect answer and 
be sure to circle the correct answer.   
 
 
 
http://www.mrc.ac.uk/research/facilities/mrc-scales/mrc-dyspnoea-scale-mrc-breathlessness-scale/ 
 
 
Description 
YES 
NO 
                                                         
 Are you ever troubled by breathlessness except on strenuous exertion?           
YES 
NO 
 
(If yes) Are you short of breath when hurrying on the level or walking up a 
slight hill? 
YES 
NO 
(If yes) do you have to walk slower than most people on the level?  Do you 
have to stop after a mile or so (or after ¼ hour) on the level at your own 
pace? 
YES 
NO 
(If yes) Do you have to stop for breath after walking about 100 yds. (or after 
a few minutes) on the level? 
YES 
NO 
(If yes) Are you too breathless to leave the house, or breathless after 
undressing? 

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Chronic Respiratory Questionnaire (CRQ-SAS) 
 
First Administration 
 
 

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McMaster University  
Canada 
 
 
 
 
Chronic Respiratory Questionnaire 
 
Self-Administered Standardized Format  
(CRQ-SAS) 
 
First Administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-
Administered Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. 
Schünemann, are the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license 
from McMaster University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. 
Contact the McMaster Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details. 
 
 
 

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CHRONIC RESPIRATORY QUESTIONNAIRE - SELF ADMINISTERED - STANDARDIZED 
ACTIVITIES - “CRQ-SAS” 
 
 
 
 
 
 
 
 
 
 
Participant ID:    
 
Date 
 
 
  
 
  
 
 
 
 
DAY 
 
MONTH 
 
YEAR 
CHRONIC RESPIRATORY QUESTIONNAIRE -SAS- FIRST ADMINISTRATION 1(10) 
 
 
This questionnaire is designed to find out how you have been feeling during the last 2 
weeks.  In the first section, you will be asked to answer questions about activities which 
make some people feel short of breath.  In the next section, you will answer questions 
about your mood and how you have been feeling. 
 
Please read these instructions for completing this questionnaire: 
 
 
 
 
 
Please read each question carefully and then place an "x" in the box beside the 
answer that best describes you.  
 
 
If you are unsure about how to answer a question, please give the best answer you 
can. 
 
 
If you would like to change an answer, put a line through the box you want to 
change.  Place an "x" in the box beside the option you would like to choose instead. 
 
 
There are no right or wrong answers.  
 
 
Your answers to this questionnaire will be kept confidential. 
 
 
 
Please continue on the next page. 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details.                                                          1 of 10 
 
 
 

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CHRONIC RESPIRATORY QUESTIONNAIRE - SELF ADMINISTERED - STANDARDIZED 
ACTIVITIES - “CRQ-SAS” 
 
 
Date 
 
 
  
 
  
 
 
 
 
DAY 
 
MONTH 
 
YEAR 
CRQ-SAS- 1ST ADMINISTRATION 
 
Below is a list of activities which make some people with lung problems feel short of breath. 
 
 
For each of the activities below, place an "x" in the box that best describes how much shortness of breath you 
have had while doing that activity during the LAST 2 WEEKS. 
 
 
The last column has been provided for you to indicate if you have NOT DONE an activity during the last two 
weeks. 
 
(Place an "x" in one box on each line) 
 
ACTIVITIES: 
Extremely 
short of 
breath 
Very  
short of 
breath 
Quite a  
bit short of 
breath 
Moderate 
shortness  
of breath 
Some 
shortness  
of breath 
A little 
shortness 
of breath 
Not at all 
short of 
breath 
Not 
Done 
 
 
 
 
 
 
 
 
 
 
1 
Feeling emotional such as 
angry or upset 
 
 
 
 
 
 
 
 
2 
Taking care of your basic 
needs (bathing, showering, 
eating or dressing) 
 
 
 
 
 
 
 
 
3 
Walking 
 
 
 
 
 
 
 
 
4 
Performing chores (such as 
housework, shopping 
groceries) 
 
 
 
 
 
 
 
 
5 
Participating in social 
activities 
 
 
 
 
 
 
 
 
Please continue to the next page. 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details.                                                       2 of 10 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 

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These next questions ask you about your energy in general and how your mood has 
been during the LAST 2 WEEKS.  Please put an "x" in a box, from 1 to 7, that best 
describes how you have felt. 
 
6. In general, how much of the time during the LAST 2 WEEKS have you felt 
frustrated or impatient? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
7. How often during the LAST 2 WEEKS did you have a feeling of fear or panic when 
you had difficulty getting your breath? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details.                                                          3 of 10 
 
 
(Place an "x" in one box only) 
(Place an "x" in one box only) 

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8. What about fatigue?  How tired have you felt over the LAST 2 WEEKS? 
 
1. 
Extremely tired 
2. 
Very tired 
3. 
Quite a bit of tiredness 
4. 
Moderately tired 
5. 
Somewhat tired 
6. 
A little tired 
7. 
Not at all tired 
9. How often during the LAST 2 WEEKS have you felt embarrassed by your coughing 
or heavy breathing? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details.                                               4 of 10 
 
 
 
(Place an "x" in one box only) 
(Place an "x" in one box only) 

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10. In the LAST 2 WEEKS, how much of the time did you feel very confident and sure 
that you could deal with your illness? 
 
1. 
None of the time  
2. 
A little of the time 
3. 
Some of the time 
4. 
A good bit of the time 
5. 
Most of the time 
6. 
Almost all of the time 
7. 
All of the time  
11. How much energy have you had in the LAST 2 WEEKS? 
 
1. 
No energy at all 
2. 
A little energy 
3. 
Some energy 
4. 
Moderately energetic 
5. 
Quite a bit of energy 
6. 
Very energetic 
7. 
Full of energy 
Please continue to the next page 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
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(Place an "x" in one box only) 
(Place an "x" in one box only) 

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12. In general, how much of the time did you feel upset, worried, or depressed during 
the LAST 2 WEEKS? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
13. How often during the LAST 2 WEEKS did you feel you had complete control of your 
breathing problems? 
 
1. 
None of the time  
2. 
A little of the time  
3. 
Some of the time 
4. 
A good bit of the time 
5. 
Most of the time 
6. 
Almost all of the time 
7. 
All of the time 
Please continue to the next page 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
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(Place an "x" in one box only) 
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14. How much of the time during the LAST 2 WEEKS did you feel relaxed and free of 
tension? 
 
1. 
None of the time  
2. 
A little of the time 
3. 
Some of the time  
4. 
A good bit of the time 
5. 
Most of the time 
6. 
Almost all of the time 
7. 
All of the time 
15. How often during the LAST 2 WEEKS have you felt low in energy? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                                 7 of 10 
 
 
(Place an "x" in one box only) 
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16. In general, how often during the LAST 2 WEEKS have you felt discouraged or down 
in the dumps? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
17. How often during the LAST 2 WEEKS have you felt worn out or sluggish? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                                 8 of 10 
 
 
(Place an "x" in one box only) 
(Place an "x" in one box only) 

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18. How happy, satisfied, or pleased have you been with your personal life during the 
LAST 2 WEEKS? 
 
1. 
Very dissatisfied, unhappy most of the time 
2. 
Generally dissatisfied, unhappy 
3. 
Somewhat dissatisfied, unhappy 
4. 
Generally satisfied, pleased 
5. 
Happy most of the time 
6. 
Very happy most of the time 
7. 
Extremely happy, could not be  
more satisfied or pleased 
 
19. How often during the LAST 2 WEEKS did you feel upset or scared when you had 
difficulty getting your breath? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                               9 of 10 
 
 
(Place an "x" in one box only) 
(Place an "x" in one box only) 

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20. In general, how often during the LAST 2 WEEKS have you felt restless, tense, or 
uptight? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
THANK YOU 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                                  10 of 10 
 
 
 
(Place an "x" in one box only) 

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APPENDIX II: FOLLOW UP BOOKLET 
 
 
 
 
 

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LINEAR ANALOGUE SELF ASSESSMENT 
 
Directions: Please circle the number (0-10) best reflecting your response to the following 
that describes your feelings during the past week, including today. 
How would you describe: 
 
1. Your overall Quality of Life? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
2. Your overall mental (intellectual) well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
3. Your overall physical well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
4. Your overall emotional well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
5. Your level of social activity? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
6. Your overall spiritual well being? 
 
As bad 
as it can 
be  
  
  
  
  
  
  
  
  
  
As good 
as it can 
be 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 

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Medical Research Council (MRC) Breathlessness Scale 
 
INSTRUCTIONS: Please read each statement carefully.  If you agree with the statement please circle 
YES.  If you disagree with the statement please circle NO.  Please be sure to answer all the questions.  
Only circle 1 answer for each question.  If you make a mistake, place an X over the incorrect answer and 
be sure to circle the correct answer.   
 
 
 
 
http://www.mrc.ac.uk/research/facilities/mrc-scales/mrc-dyspnoea-scale-mrc-breathlessness-scale/ 
 
 
Description 
YES 
NO 
                                                         
Are you ever troubled by breathlessness except on strenuous exertion? 
Grade 1                                                     
YES 
NO 
 
(If yes) Are you short of breath when hurrying on the level or walking 
up a slight hill? 
 Grade 2 
 
YES 
NO 
(If yes) Do you have to walk slower than most people on the level? Do 
you have to stop after a mile or so (or after ¼ hour) on the level at your 
own pace? Grade 3 
 
YES 
NO 
(If yes to either) Do you have to stop for breath after walking about 100 
yards (or after a few minutes) on the level? 
 Grade 4 
YES 
NO 
(If yes) Are you too breathless to leave the house, or breathless after 
undressing?Grade 5 

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Chronic Respiratory Questionnaire 
 
Self-Administered Standardized Format  
(CRQ-SAS) 
 
Follow-up Administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire 
Self-Administered Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. 
Guyatt, and Dr. H.J. Schünemann, are the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ 
has been provided under license from McMaster University and must not be copied, distributed or used in any way without the 
prior written consent of McMaster University. Contact the McMaster Industry Liaison Office at McMaster University, email: 
milo@mcmaster.ca for licensing details. 
 
 
 

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CHRONIC RESPIRATORY QUESTIONNAIRE - SELF ADMINISTERED - STANDARDIZED 
ACTIVITIES - “CRQ-SAS” 
FOLLOW-UP - ADMINISTRATION 
 
 
 
 
 
 
 
 
 
 
Participant ID:    
 
Date 
 
 
  
 
  
 
 
 
 
DAY 
 
MONTH 
 
YEAR 
CHRONIC RESPIRATORY QUESTIONNAIRE -SAS- FOLLOW-UP ADMINISTRATION  
 
You have previously completed a questionnaire containing questions on how you have 
been feeling and how your lung disease was affecting your life. This is a follow up 
questionnaire designed to ask you how you have been since that time. 
 
Please read these instructions for completing this questionnaire: 
 
 
 
 
Please read each question carefully and then place an "x" in the box beside the 
answer that best describes you.  
 
 
If you are unsure about how to answer a question, please give the best answer you 
can. 
 
 
If you would like to change an answer, put a line through the box you want to 
change.  Place an "x" in the box beside the option you would like to choose instead. 
 
 
Remember there are no right or wrong answers. 
 
 
Your answers to this questionnaire will be kept confidential. 
 
 
 
Please continue on the next page. 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details.                                                           1 of 10 
 
 
 

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CHRONIC RESPIRATORY QUESTIONNAIRE - SELF ADMINISTERED - STANDARDIZED 
ACTIVITIES - “CRQ-SAS” 
FOLLOW-UP - ADMINISTRATION 
 
Date 
 
 
  
 
  
 
 
 
 
DAY 
 
MONTH 
 
YEAR 
CRQ-SAS- FOLLOW-UP ADMINISTRATION 
 
 
 
This questionnaire is designed to find out how you have been getting along since the last time you saw 
us. You previously completed this questionnaire telling us how short of breath you were while performing 
the following activities. 
 
 
For each of the activities below, place an "x" in the box that best describes how much shortness of breath 
you have had while doing that activity during the LAST 2 WEEKS. 
 
 
The last column has been provided for you to indicate if you have NOT DONE an activity during the last two 
weeks. 
 
(Place an "x" in one box on each line) 
 
ACTIVITIES: 
Extremely 
short of 
breath 
Very  
short of 
breath 
Quite a  
bit short of 
breath 
Moderate 
shortness  
of breath 
Some 
shortness  
of breath 
A little 
shortness 
of breath 
Not at all 
short of 
breath 
Not 
Done 
 
 
 
 
 
 
 
 
 
 
1 
Feeling emotional such as 
angry or upset 
 
 
 
 
 
 
 
 
2 
Taking care of your basic 
needs (bathing, showering, 
eating or dressing) 
 
 
 
 
 
 
 
 
3 
Walking 
 
 
 
 
 
 
 
 
4 
Performing chores (such as 
housework, shopping 
groceries) 
 
 
 
 
 
 
 
 
5 
Participating in social 
activities 
 
 
 
 
 
 
 
 
                                                Please continue to the next page.  
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-
Administered Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. 
Schünemann, are the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license 
from McMaster University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. 
Contact the McMaster Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                   2 of 10 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
5 
6 
7 
8 

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These next questions ask you about your energy in general and how your mood has 
been during the LAST 2 WEEKS.  Please put an "x" in a box, from 1 to 7, that best 
describes how you have felt. 
 
6. In general, how much of the time during the LAST 2 WEEKS have you felt 
frustrated or impatient? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
7. How often during the LAST 2 WEEKS did you have a feeling of fear or panic when 
you had difficulty getting your breath? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-
Administered Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. 
Schünemann, are the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license 
from McMaster University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. 
Contact the McMaster Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                  3 of 10 
 
 
 
(Place an "x" in one box only) 
(Place an "x" in one box only) 

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8. What about fatigue?  How tired have you felt over the LAST 2 WEEKS? 
 
1. 
Extremely tired 
2. 
Very tired 
3. 
Quite a bit of tiredness 
4. 
Moderately tired 
5. 
Somewhat tired 
6. 
A little tired 
7. 
Not at all tired 
9. How often during the LAST 2 WEEKS have you felt embarrassed by your coughing 
or heavy breathing? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                               4 of 10 
 
 
(Place an "x" in one box only) 
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10. In the LAST 2 WEEKS, how much of the time did you feel very confident and sure 
that you could deal with your illness? 
 
1. 
None of the time  
2. 
A little of the time 
3. 
Some of the time 
4. 
A good bit of the time 
5. 
Most of the time 
6. 
Almost all of the time 
7. 
All of the time  
11. How much energy have you had in the LAST 2 WEEKS? 
 
1. 
No energy at all 
2. 
A little energy 
3. 
Some energy 
4. 
Moderately energetic 
5. 
Quite a bit of energy 
6. 
Very energetic 
7. 
Full of energy 
Please continue to the next page 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                                5 of 10 
 
 
(Place an "x" in one box only) 
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12. In general, how much of the time did you feel upset, worried, or depressed during 
the LAST 2 WEEKS? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
13. How often during the LAST 2 WEEKS did you feel you had complete control of your 
breathing problems? 
 
1. 
None of the time  
2. 
A little of the time  
3. 
Some of the time 
4. 
A good bit of the time 
5. 
Most of the time 
6. 
Almost all of the time 
7. 
All of the time 
Please continue to the next page 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                            6 of 10 
 
 
(Place an "x" in one box only) 
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14. How much of the time during the LAST 2 WEEKS did you feel relaxed and free of 
tension? 
 
1. 
None of the time  
2. 
A little of the time 
3. 
Some of the time  
4. 
A good bit of the time 
5. 
Most of the time 
6. 
Almost all of the time 
7. 
All of the time 
15. How often during the LAST 2 WEEKS have you felt low in energy? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                              7 of 10 
 
 
(Place an "x" in one box only) 
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16. In general, how often during the LAST 2 WEEKS have you felt discouraged or down 
in the dumps? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
17. How often during the LAST 2 WEEKS have you felt worn out or sluggish? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                                   8 of 10 
 
 
(Place an "x" in one box only) 
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18. How happy, satisfied, or pleased have you been with your personal life during the 
LAST 2 WEEKS? 
 
1. 
Very dissatisfied, unhappy most of the time 
2. 
Generally dissatisfied, unhappy 
3. 
Somewhat dissatisfied, unhappy 
4. 
Generally satisfied, pleased 
5. 
Happy most of the time 
6. 
Very happy most of the time 
7. 
Extremely happy, could not be more 
satisfied or pleased 
 
19. How often during the LAST 2 WEEKS did you feel upset or scared when you had 
difficulty getting your breath? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
Please continue to the next page 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                                  9 of 10 
 
 
 
(Place an "x" in one box only) 
(Place an "x" in one box only) 

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20. In general, how often during the LAST 2 WEEKS have you felt restless, tense, or 
uptight? 
 
1. 
All of the time 
2. 
Most of the time 
3. 
A good bit of the time 
4. 
Some of the time 
5. 
A little of the time 
6. 
Hardly any of the time 
7. 
None of the time 
THANK YOU 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 07July15 Copyright © 2001 McMaster University, Hamilton, Ontario, Canada. The Chronic Respiratory Questionnaire Self-Administered 
Standardized (CRQ-SAS) and Self-Administered Individualized (CRQ-SAI), Principal authors Drs. G.H. Guyatt, and Dr. H.J. Schünemann, are 
the copyright of McMaster University (Copyright ©2001, McMaster University). The CRQ has been provided under license from McMaster 
University and must not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster 
Industry Liaison Office at McMaster University, email: milo@mcmaster.ca for licensing details                                                             10 of 10 
 
 
 
 
(Place an "x" in one box only) 

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APPENDIX III: PAIN SCALE & HOSPITAL EXPERIENCE  
 
 
Patient Initials: ________________________________ Date: ______________________ 
Patient Number: ______________________________ 
 
 
Directions: Please circle the answer that best reflects the level of pain that you experienced after you 
were discharged from the hospital. 
 
 
1. Please rate your pain by using the number that best describes your pain at its worst in the last two 
weeks?  
 
 
      0 
     1 
      2 
      3 
      4 
      5 
     6 
     7 
      8 
      9 
       10 
          None  
 
 
 
 
 
 
                 As bad as I can imagine 
 
  
2. Please rate your pain by using the number that best describes your pain at its least in the last two 
weeks?   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
None 
 
 
 
 
 
 
 
             As bad as I can imagine 
 
3. How would you rate your hospital experience?   
 
Poor  
 
 
fair  
 
good   
very good  
 
or excellent 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX IV: CHECKLIST FOR MEDICAL RECORDS 
 
PULMONARY REHABILITATION BEFORE LUNG CANCER RESECTION 
_____________________________________________________________________________________ 
 
Admission Date:  _______________ 
  Discharge Date: _______________  ID Number:____________ 
 
____________________________________________________________________________________ 
Please provide the following documents related to the Lung Surgical Resection for this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
YES 
 
NO 
Admission Report 
 
 
 
 
 
     
     (Admitting history and Physical Exam) 
 
 
 
 
 
 
 
Operative Report 
     (Description of procedure performed and Number of chest tubes placed) 
 
 
 
 
 
 
 
Discharge Summary 
     (Dismissal information including location Subject dismissed to i.e. home, rehab facility, etc.) 
 
 
 
 
 
 
 
Progress Report 
     (Daily notes including description of any complications) 
 
 
 
 
 
 
 
Reports of results from: 
 
 
 
     Radiology (Report only, images not needed) 
 
 
 
 
     Blood/Lab Draws