Participation Information and Consent form

Evaluating an Online Healthy Living Program for Cancer Survivors

Chief Investigator:

Associate Professor Lisa Beatty

College of Education, Psychology and Social Work,

Flinders University

Email: lisa.beatty@flinders.edu.au

Associate Investigator:

Ms Morgan Leske

College of Education, Psychology and Social Work,

Flinders University

Email: morgan.leske@flinders.edu.au

Healthy Living after Cancer Online is a free online program run by Cancer Council SA for adults who have completed treatment for cancer. If you take part, you will receive access to the online program, which includes information and tasks to support you to make healthy lifestyle changes. Healthy Living after Cancer Online aims to support multiple areas of health and well-being, including exercise, healthy eating, mental health, and finding your new normal after cancer.  

Introduction 

You are invited to take part in a research project called ‘Evaluating an online healthy living program for cancer survivors.’ The research project is trialling a new program to support people who have completed cancer treatment in making healthy lifestyle choices. The program is called Healthy Living after Cancer Online.  

This information and consent form tells you about the research project and explains what is involved by taking part. Knowing what is involved will help you decide if you want to take part in the research. Please read this information carefully. 

Before deciding whether or not to take part, you might want to talk about it with a relative, friend, or local health worker. 

Participation in this research is voluntary. If you do not wish to take part, you do not have to.  

If you decide to take part in this research, you will be asked to sign up for the program. By signing up for Healthy Living after Cancer Online, you are telling us that you: 

• Understand what you have read 
• Consent to take part in the research described 
• Consent to the use of your personal and health information for this research project 

The purpose of this research: 

Cancer Council SA is looking at new ways of providing a free program to support survivors of cancer, such as yourself, to make healthy lifestyle changes. The purpose of the current study is to evaluate the feasibility and efficacy of adding a telephone coaching element to the Healthy living after Cancer Online program. 

What is Healthy Living after Cancer Online? 

Healthy Living after Cancer Online is a free online healthy Living program run by Cancer Council SA for adults who have completed cancer treatment.  

Getting back to a healthy lifestyle after cancer is important. Research tells us that, for cancer survivors, making healthy lifestyle changes may help to improve quality of life and wellbeing. For example, exercising more and eating better may reduce the side effects of cancer and its treatment. It may also reduce the risk of cancer returning and reduce the risk of other chronic problems like heart disease or diabetes. 

Healthy Living after Cancer Online aims to support you in making healthy lifestyle changes, so that you can do more of the things you want to. The program includes information and tasks in nine different areas including:  

• Goal setting 
• Finding the new normal 
• Physical activity 
• Healthy eating 
• Mental health 
• Fatigue management 
• Maintaining a healthy weight
• Peer support.
• Staying on track.  

What does participation in this research involve? 

You are invited to participate in this research if you: 

• are 18 years of age or older 
• Diagnosed with localised (i.e., non-metastatic) potentially curative cancer of any type. 
• have completed cancer treatment (please note: you are still eligible if receiving hormonal treatment or Herceptin) 
• Able to speak and read English 
• Live in Australia 
• If you have a heart condition, diabetes, a breathing problem requiring hospitalisation in the past 6 months, undergoing dialysis, planning a knee or hip replacement in the next six months, are pregnant or breastfeeding or have a body mass index below 17.5 then this study may not be suitable for you.   

If you meet the eligibility criteria and choose to participate, you can sign up to Healthy Living after Cancer Online once you have read this information sheet and consent form.  

If you choose to participate, you will be randomly allocated by chance (similar to flipping a coin) to receive either the Healthy living after Cancer Online program plus telephone coaching, or to receive the Healthy living after Cancer Online program only. You will have an equal chance of allocation to each group, but we cannot place you in the group of your choice. You will be asked to work through an online program for 12 weeks. Questionnaires will be collected online once before and three times after using the program (i.e., after using the intervention for 12 weeks, 16 weeks, and 24 weeks). The questionnaires will include information about your demographics, health history (including your cancer diagnosis), physical activity, diet, quality of life, distress, and cancer-related symptoms.  

If you are allocated to the telephone coaching group, you will also receive 2x one-on-one 15-minute telephone sessions with a Provisional Psychologist during the first and fourth weeks of the program. The purpose of these sessions will be to help identify goals that are meaningful to you, to help plan activities that will assist you to meet your goals, and to check your progress in meeting these goals over time. 

Following the second questionnaire, you will also be offered the opportunity to provide additional feedback on the program via an interview, which can be done via the telephone or zoom. The interview will take approximately 30-60 minutes.  

Voluntary Participation and Privacy 

Participation in this project is voluntary, and you can withdraw at any time. Your participation in this study and any information you provide will remain confidential. Your decision to take part or not, or to withdraw, will not affect your relationship with Cancer Council. 

All records containing personal information will remain confidential and no information that could lead to your identification will be released or published. All information and results obtained in this study will be stored in a secure way, with access restricted to relevant researchers. 

All information that you include within the Healthy Living after Cancer Online (including trackers and activities) will be for your personal use only and will not be accessed by researchers or used for research purposes.  

What are the possible benefits of taking part? 

Your participation in this research will benefit our understanding of life after cancer treatment and whether online support can help improve the lives of cancer survivors through healthy living. You may not personally benefit from this study; however, other people participating in similar programs aimed at supporting physical activity and healthy eating after cancer have reported significant improvements in their quality of life.  

What are the possible risks of taking part? 

Some of the topics addressed in this research are of a sensitive nature, including your cancer diagnosis and some of the challenges you may have experienced that are associated with a cancer diagnosis. If you choose to increase your exercise, you may also experience some minor soreness in your muscles, particularly the day after exercise sessions. 

There is also a possibility of being inconvenienced by this research because of the time taken to participate in the questionnaires and the interview.  

Please be assured, that you can discontinue your participation without any consequence. If you are uncomfortable answering a question in the questionnaires or the interview, you can choose not to.  

If any aspect of participating in this research causes you distress, you can contact the Cancer Council Information and Support Service on 13 11 20.

If you need immediate assistance, please contact Lifeline 24-hour crisis support on 13 11 14. 

Who can I speak to if I have questions? 

If you have any questions about the program or would like any more information before deciding to take part, please contact the primary researcher, Morgan Leske, via phone (08) 08 8201 2192, or via email at morgan.leske@flinders.edu.au.   

Approvals 

This project has been approved by Cancer Council Victoria’s Human Research Ethics Committee (HREC 2106). If you have any complaints or concerns about the way in which this program is being conducted or evaluated, please contact rgu@cancervic.org.au 

By signing up for Healthy Living after Cancer Online, I consent to participate in the study, ‘Evaluating an online healthy living program for cancer survivors‘. I agree that:

• I understand the purposes, procedures and risks of the research described in the project.
• I have had an opportunity to ask questions and I am satisfied with the answers I have received.
• I freely agree to participate in this research project as described and understand that I am free to withdraw at any time during the project without affecting my future care by contacting morgan.leske@flinders.edu.au.