Clinical trial: NCT04575831
Section: Confidentiality
Subsections: How Will My Personal Information Be Kept Confidential?

If you decide to participate in this study, the study doctor and study staff will only collect the information they need for this study. Records identifying you, including information collected from your medical files/records, such as your Electronic Medical Records (EMR), Netcare, charts, etc., will be kept confidential to the extent permitted by the applicable laws, will not be disclosed or made publicly available, except as described in this consent document. Authorized representatives of the following organizations may look at your identifiable medical/clinical study records at the site where these records are held for quality assurance purposes and/or to verify that the information collected for the study is correct and follows proper laws and guidelines:  
- Members of the Regulatory/Audit team at the Universty of Calgary, for quality assurance purposes;
- The Health Research Ethics Board of Alberta - Cancer Committee, which oversees the ethical conduct of this study
To protect your identity, all personal information will be kept in a file that is only identifiable by an ID number. It will be locked in a filing cabinet in a secure lab office in the Faculty of Kinesiology at the University of Calgary. All uploaded data (e.g., online diet records, Fitbit data),
will be kept on a password protected secure server, on a password-protected computer in the secure lab office mentioned above. Only pre-approved staff members will have access to this data. Hard copy data (e.g., questionnaires on personal well-being, including quality of life, fatigue, and symptom burden), will be kept for 5 years, and will then be shredded. The ID number identification table will only be available to the study team, including the Principal Investigator, co-investigators and the research assistants. The personal information including name, email and contact phone number will be removed from your questionnaire and kept in a file that is locked in a filing cabinet in a secure lab office in the Faculty of Kinesiology at the University of Calgary. This information will not be uploaded with the study data and will be kept separate from the study data. Only pre-approved staff members will have access to this data. This personal contact information may be used to contact you to determine your interest in an interview following the program. Any disclosure of your identifiable health information will be done in accordance with federal and provincial laws including the Alberta Health Information Act (HIA). The organizations listed above are required to have organizational policies and procedures to protect the information they see or receive about you, except where disclosure may be required by law. The study team will ensure that any personal health information collected for this study is kept in a secure and confidential location in the Faculty of Kinesiology at the University of Calgary, as also required by law. If the results of this study are published, your identity will remain confidential. It is expected that the information collected during the study will be published/presented to the scientific community at meetings and in journals.  
Even though the likelihood that someone may identify you from the study data is very small, it www.thriveforcancersurvivors.com Version date of this form: May 23, 2019 Page 7 of 11 Ethics ID: HREBA.CC-18-0681 can never be completely eliminated. Every effort will be made to keep your identifiable  
  
 information confidential, and to follow the ethical and legal rules about collecting, using and disclosing this information.  
Should you wish to withdraw from the study prior to data analysis, the information that you provided will be destroyed and not included in the final report of the research project. If you withdraw after data analysis, the information you provided will be included in the final report of the research. Participation is completely voluntary and confidential. You are free to discontinue participation at any time during the study. Names will not be included in the group data. The group data will be summarized for any presentation or publication of results. Studies involving humans sometimes collect information on race and ethnicity as well as other characteristics of individuals because these characteristics may influence how people respond to different interventions. Providing information on your race or ethnic origin is voluntary.
Clinical trial: NCT04575831
Section: Participant Responsibilities
Subsections: What Are My Responsibilities As A Study Participant?

If you choose to participate in this study, you will be expected to:
- Attend all scheduled study visits and undergo all of the procedures described above.  
Your participation in this study does not involve anything else beyond what is specified on this informed consent.
Clinical trial: NCT04575831
Section: Participant's Rights
Subsections: What Are My Rights As A Participant In This Study?

You have the right to be informed of the results of this study once the entire study is complete. If you would like to be informed of these results, please contact the study doctor.  
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. No funds have been set aside to compensate you by the Health and Wellness Lab, the University of Calgary, Alberta Health Services or the Researchers, in the event that you suffer injury as a result of participating in this www.thriveforcancersurvivors.com Version date of this form: May 23, 2019 Page 8 of 11 Ethics ID: HREBA.CC-18-0681 research.  
  
 By signing this form you do not give up any of your legal rights against the hospital, investigators, sponsor, involved institutions for compensation or their agents, nor does this form relieve these parties from their legal and professional responsibilities.
Clinical trial: NCT04575831
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Potential Side Effects From Participating In This Study?|What Are The Benefits Of Participating In This Study?|Will There Be Any Costs Involved With Participating In This Study?|Will I Be Compensated For Participating In This Study?

There are risks associated with involvement in any exercise program. The research team will watch you closely to see if you have side effects. However, screening will determine your ability to be active and involved in the program, thereby reducing the potential risks. There are no other known physical or psychological risks associated with involvement in the program. However, if at any time during the study you are identified as distressed or upset, referrals to psychosocial resources at the Tom Baker Cancer Centre will be made available.

If you agree to participate in this study, there may or may not be a direct benefit to you. An increase in physical activity may lead to an increased sense of well-being and quality of life, reduced feelings of depression, anxiety, and stress, and may improve physical fitness. These may be improved during the study, but there is no guarantee this research will help you. The information from this study may help us to provide better resources to help people cope with advanced lung cancer in the future.

There are no costs associated with participating in this research study. You will be provided with a parking pass (value $8.00) to attend your baseline and follow up testing sessions at the University of Calgary. The physical activity intervention will be available to you free of charge while you take part in this study. Participation in this study will not involve any additional costs to you or your private health care insurance.

You will not be paid for taking part in this study. However, you will be provided with an exercise ball, yoga mat and resistance band to help you exercise at home. You will also be provided with a Fitbit, which will be yours to use during the duration of the intervention, and returned to the program coordination upon program completion. Although no funds have been set aside to compensate you in the event of injury or illness related to the study treatment or procedures, you do not give up any of your legal rights for compensation by signing this form.
Clinical trial: NCT04575831
Section: Procedures
Subsections: What Will Happen During This Study? Assignment To A Group|Study Intervention|Study Procedures

All participants will receive the physical activity and nutrition intervention along with complex care symptom management. There will be up to 15 participants enrolled in the study. During the study, you may be given the option of deciding to participate in semi-structured interviews.

The goal of this study is to examine the feasibility of introducing an intervention that includes exercise and nutrition in conjuction with palliative symptom management, and examine the potential relationship with quality of life in advanced non-small-cell lung cancer (NSCLC)
patients. We will also examine the impact of the intervention on I) fatigue, II) functional fitness and III) symptom burden. This intervention will not interfere with your ongoing care or any treatments recommended by your care team. If you agree to take part in this study, you will:
1. Complete questionnaires at the beginning of the study and immediately after completing the 12-week physical activity program.  
2. Complete fitness testing before and after the program at the University of Calgary. This procedure will take about 1 hour.  
3. Attend a 90 minute long exercise session 1 time per week for 12 weeks at either the REACH Centre at the Holy Cross Hospital or at the THRIVE exercise facility at the University of Calgary.  
4. The 90 minute session will include a light warm up (5-10 minutes), and 6 exercise stations with a range of functional exercises designed to target both aerobic and strength components of fitness (60 minutes), with modifications made according to your physical function at the start of the program. The main focus of the circuit will be on muscle strength, balance, flexibility and aerobic capacity as associated with beneficial daily physical function (i.e., for activities of daily living). Most group sessions will involve a series of circuit-style classes, that allow for adequate group supervision as well as the ability for individuals to work at their own pace. The exercise circuit will be followed by a 30-minute therapeutic yoga class, based on the Yoga Thrive program.  
5. Complete additional home exercises throughout the week at home. For this, you will be given a home-based exercie prescription for an additional 1-2 sessions per week facilitated by provision of basic home-based fitness equipment. You will also be provided with a Fitbit device to use for the duration of the study, and returned upon completion of the exercise www.thriveforcancersurvivors.com Version date of this form: May 23, 2019 Page 3 of 11 Ethics ID: HREBA.CC-18-0681 program. The data obtained will be downloaded and stored with no identification other than  
  
 your participant identification number.  
6. Attend a clinical visit with a Complex Cancer Care Management team clinician (physician or nurse practitioner) within the first two weeks of the intervention to assess and treat symptoms that may interfere with physical activity (i.e., pain or nausea).  
7. Complete an online self-administered 24-hr dietary food recall at 2 time points; prior to the start and at the end of the study intervention. Participants will also attend a nutrition evaluation and consultation with a Registered Dietitian (RD). Consultations will be scheduled according to participant need.  
8. Optional - attend semi-structured interviews.  
- Your involvement may also include participation in a semi-structured interview
(approximately 30 minutes long) conducted either in person at the location of your choice or over the phone. Interviews may occur within 2 weeks of program start, halfway through (at 6 weeks), or at the end of the intervention (12 weeks). The interview will include discussing your involvement with the program including barriers, preferences, feasibility and your personal well-being, including quality of life and symptom burden. You may participate in as many of the interviews as you wish.  
| Here is a summary of your study involvement: TIMELINE   | EVENT                                                                                                |                                                                                                              |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Baseline assessment                                     | -                                                                                                    | Complete baseline questionnaires                                                                             |
| (Beginnng of study)                                     | -                                                                                                    | Complete baseline fitness assessment                                                                         |
| -                                                       | Complete online self-administered 24-hr dietary food recall                                          |                                                                                                              |
| Intervention                                            | -                                                                                                    | Attend 90 minute long exercise session 1 time per week                                                       |
| (During the study)                                      | -                                                                                                    | Attend a clinical visit with a Complex Cancer Care Management  team clinician (~1-2 weeks into intervention) |
| -                                                       | Schedule a nutrition evaluation/consultation with RD (according  to participant need)                |                                                                                                              |
| -                                                       | Optional: Attend a semi-structured interview within 2 weeks  and/or at 6 weeks into the intervention |                                                                                                              |
| Post-intervention  assessment (End of study)            | -                                                                                                    | Complete post- program questionnaires                                                                        |
| -                                                       | Complete post-program fitness assessment                                                             |                                                                                                              |
| -                                                       | Complete online self-administered 24-hr dietary food recall                                          |                                                                                                              |
| -                                                       | Optional: Attend a semi-structured interview at the end of the  program                              |                                                                                                              |

Demographic and disease status data will be extracted from medical files/records, such as your Electronic Medical Records (EMR), Netcare, and/orcharts. As part of the screening procedure, you will complete the Physical Activity Readiness Questionnaire + (PAR-Q+). This will ensure that the exercise program will be safe, and that it can be tailored to your needs.  
If you are ineligible to participate due to nerve, muscular, or skeletal issues after PAR-Q+ screening, you may be referred to a Cancer Physiatrist (i.e., Dr. George Francis) for evaluation and treatment.  
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Clinical trial: NCT04575831
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this feasibility study is to help understand if it is possible to do the study with a small number of participants before a larger study is started. Because there will only be a small number of participants, it is not expected to give complete answers to the research questions and will not prove safety or effectiveness. The results may be used as a guide for larger studies, although there is no guarantee that those will be conducted.
Clinical trial: NCT04575831
Section: Voluntary Participation
Subsections: By Signing This Form I Agree To Participate In This Study.

Signature of Participant PRINTED NAME Date I consent to be contacted for potential participation in the interview portion of the study: Signature of Participant PRINTED NAME Email/ Phone number www.thriveforcancersurvivors.com Version date of this form: May 23, 2019 Page 10 of 11 Ethics ID: HREBA.CC-18-0681 Part 2 - to be completed by the study doctor or designee who conducted the informed consent  
 discussion. Only compete this section if the potential participant has **agreed** to participate.  
I believe that the person signing this form understands what is involved in the study and has freely decided to participate. Signature of Person Conducting the Consent Discussion PRINTED NAME Date Part 3 - to be completed only if the participant is unable to read or requires assistance of an oral translator/interpreter.  
- The informed consent form was accurately explained to, and apparently understood by the participant.  
- Informed consent was freely given by the participant.
Signature of Impartial  
 Witness/Interpreter PRINTED NAME Date
**You will be given a copy of this signed and dated consent form prior to participating in this study.**  
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Clinical trial: NCT04575831
Section: Withdrawal from Study
Subsections: Can I Choose To Leave This Study Early?

You can choose to end your participation in this research (called early withdrawal) at any time without having to provide a reason. If you choose to withdraw early from the study without finishing the intervention, procedure or follow-up, you are encouraged to contact the study staff.  
You may be asked questions about your experience with the study intervention. You may withdraw your permission to use information that was collected about you for this study at any time by letting the study team know. However, this would also mean that you withdraw from the study. Information that was recorded before you withdrew will be used by the researchers for the purposes of the study, but no additional information will be collected after you withdraw your permission. If you decide to leave the study, you can ask that the information that was collected about you not be used for the study. Let the study team know if you choose this.  
www.thriveforcancersurvivors.com Version date of this form: May 23, 2019 Page 6 of 11 Ethics ID: HREBA.CC-18-0681