Sub-studies

This sub-study will look at whether or not the proposed digital intervention is worth the money it costs. Data from your quality-of-life questionnaires already being collected for the main trial at weeks 0 and 24 will be used. We will also get information from administrative sources about how you use health care resources and how much it costs at three different times: 24 weeks before you are assigned to a group in the trial, and 24 weeks and 1 year after you are assigned. The data analysis for this sub-study will be conducted by a third party, and the secure handling of data will be ensured.

After completing weeks 16 and 24 of the main trial, a group of participants will be selected from both groups to take part in qualitative interviews asking about their experiences with the digital intervention and with the study overall. We will collect audio and/or video recordings of the interviews for transcription, and we will remove any identifiable information. You will have the option to choose between an in-person or virtual interview based on your preferences. In-person interviews will take place in a private room at the HNRU at the University of Alberta, while virtual interviews will be held on Zoom.

This sub-study will look at how genetic variations, like those that can happen in a DNA sequence, are linked to health behaviours and risk factors for heart diseases in endometrial cancer survivors. It will also look at how these genetic variations could affect how well the proposed digital intervention works. During the first visit of the main trial, a saliva sample of 2 mL will be collected using a collection kit to assess genetic aspects related to your health behaviours and risk factors for heart diseases. Before samples are taken, you will be asked to brush your teeth to remove any food residue if not yet done in the morning of the study visit. We will not perform any genetic testing to identify rare genetic diseases, including those caused by a change in one gene (also called monogenic diseases). You will also be asked to complete a modified version of the Yale Food Addiction Scale to measure eating habits that are similar to addictions. Other measures already collected for the main trial will be used in this substudy, including depression, anxiety, body composition, results from your blood draw, metabolic syndrome, and cardiovascular risk.

This sub-study will look at how common cardiac dysfunction is among people who have survived endometrial cancer, what is the heart’s pumping capacity during exercise, how they are linked to the risk of heart and metabolic diseases, and how health behaviors can change this link. Various measures already been collected for the main study at baseline will be used, including cardiac dysfunction and amount of fat in the liver measured with MRI; body composition by DXA; cardiopulmonary exercising test; cardiovascular risk; demographics; smoking status; blood markers related to cardiovascular health; cancer treatment type; physical activity; dietary and alcohol intake; and stress. You will have the option to complete an additional exercise MRI test for this sub-study to evaluate your heart's pumping capacity during exercise. 

This sub-study will look at how common bad childhood experiences are among endometrial cancer survivors and how they affect overall health. For this sub-study you will be asked to answer the Childhood Trauma Questionnaire, which is a self-administered questionnaire that assesses traumatic experiences in childhood, such as emotional, physical, or sexual abuse and neglect. This questionnaire is completed along with other surveys collected at baseline. Various other measures already being collected for the main trial at baseline will be used in this substudy, including body weight, waist circumference, fat mass, circulating biomarkers, metabolic syndrome, quality of life, stress, depression, and anxiety.

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