Patient Reported Outcomes (PROs) are measures or questionnaires and they are the best way to collect information about a patient’s condition directly from the patient. When PROs are presented electronically through a mobile or a web application, they are called ePROs. Their main advantage is that they can enhance communication between patients and health care providers both in an inpatient and the outpatient phase of care.
MYPAL ADULT STUDY
In the context of the MyPal Adult study, 300 patients with blood cancer i.e. Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome will be invited to participate. These patients will be approached in the specialized clinical centers located in Italy, Sweden, Greece and the Czech Republic where they are receiving care. Of these patients, 150 will be randomly assigned to the intervention group which means that they will be asked to use the MyPal app actively for a period of 12 months. In order to better understand the patients’ cancer journey experience and for their clinicians to be able to intervene when necessary, the MyPal team will ask patients to complete a number of PROs on a weekly basis through the MyPal mobile app.
The MyPal team has chosen 3 different ePROs: namely the Edmonton Symptom Assessment System (ESAS), the Brief Pain Inventory (BPI) and the Emotion Thermometers (ET). All the information patients record through these ePROs will automatically become available to their healthcare team who will be closely monitoring patients’ experience of physical and emotional symptoms and offer palliative care whenever this is considered necessary. More particularly:
- ESAS is a single page comprehensive questionnaire which aims to assess a variety of symptoms often experienced by cancer patients and stem either from cancer or cancer treatment such as fatigue, nausea, drowsiness, loss of appetite etc. The reason ESAS was chosen is that it quickly assesses multiple symptoms and can be very useful in managing symptoms as well as assessing subtle symptom changes which are important.
- BPI was chosen because it focuses on the assessment of pain, an important symptom which is greatly affecting patients’ quality of life. Pain is predominantly a subjective experience so it can greatly vary among patients with the same condition. BPI was designed to measure not only the intensity of pain cancer patients experience but also the impact this pain has on how they function in everyday life, in other words the pain’s interference with life’s activities and its enjoyment.
- Finally, ET is a brief single page questionnaire focusing on the assessment of feelings. Going through cancer treatment can be an intensely emotional experience. Many cancer patients experience negative feelings which might range from being unpleasant to disabling. Through the ET, patients can indicate whether they feel distress, anxiety, depression, anger and how intensely they are experiencing those feelings. Furthermore, patients can also indicate whether they need help in coping with those feelings.
In order to determine whether the MyPal intervention has been successful, the MyPal team will ask all 300 patients from both the intervention and the control group to fill in a number of additional ePROs on a monthly basis through a web application and compare the results between patient who used the MyPal mobile app and the control group patients. Specifically, the 4 ePROs used for this purpose are the following: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Patient Satisfaction with Cancer Care questionnaire (EORTC PATSAT C33), the EuroQol Quality of Life Questionnaire (EQ-5D) and the Palliative Care Outcome Scale (IPOS).
- The European Organization for Research and Treatment of Cancer is a leading pan-European clinical cancer research organization which coordinates high quality research to improve the quality of life of patients with cancer. In the context of this work, EORTC developed a specialized questionnaires for cancer patients. EORTC QLQ-C30 is a two-page questionnaire which assesses patients’ physical and emotional symptoms, their ability to function as well as their perceived impact of cancer and its treatment. Quality of life measures are designed to highlight patients’ assessment of their own situation. This can help doctors understand what patients are struggling with and therefore make or revisit some decisions regading treatment.
- The EORTC PATSAT C33 is a three-page questionnaire which assesses patients’ satisfaction with doctors, nurses and healthcare services received in the healthcare organization they had their most recent care experience. It is very important to consider patients’ satisfaction with the care they receive. Not only does it tell doctors about patient experience, it can drive healthcare organizations to improve the quality of care that is centered around the patients’ needs.
- The EQ-5D is a short questionnaire that measures QoL of patients with a range of conditions including cancer. The reason why EQ-5D has been chosen is that it assesses several aspects of QoL such as patients’ current mobility, ability to self-care or to carry out usual activities. Furthermore, whether patients are in pain or whether they feel anxious or depressed.
- Last but not least the IPOS is a short questionnaire which was chosen because it has been developed specifically for patients with life limiting diseases including cancer. IPOS is unique in that it is currently the only questionnaire which can assess patients’ palliative care needs. These maybe information or support needs in response to the physical, psychological, emotional and spiritual symptoms experienced by patients. Patients’ responses can help healthcare teams identify gaps in healthcare provided and plan for care that is more focused on patients’ needs.
MYPAL CHILD STUDY
In the context of the MyPal CHILD study, 100 children with blood and other types of cancer will be invited to participate. These patients will be approached in specialized clinical centers located in Germany and the Czech Republic. Similarly, to the MyPal Adult study, children will be asked to use the MyPal Child app for a period of six months. Specifically, children will be asked to fill a questionnaire called SSPedi throughout the course of the study. The reason why this particular questionnaire was chosen was that there are many versions, which can be understood by children of different ages such as the Mini SSPedi appropriate for children between 4-7 years of age.
- The SSPedi contains a list of physical and psychological symptoms and assesses how bothered children are by these symptoms. In order to make this process easier for children, the MyPal team has decided to incorporate SSPedi into a game. The way this will work is that children will be able to choose a game character who will be running through the game, collecting treasures and avoiding obstacles. The SSPedi will be presented in between the game runs.
- Furthermore, children are also asked to complete the PedsQL Cancer module which is a questionnaire designed to measure the QoL of children with cancer. It assesses physical or emotional symptoms but also areas that might present an issue for children such as anxiety about procedures, difficulty to communicate with the doctor or being conscious about one’s appearance. As with SSPedi, PedsQL has a number of different versions to cater for different age groups.
Parents and carers are asked to complete other relevant ePROs through their own MyPal Carer app. These include the EQ-5D which assesses QoL and has already been described. Also, the EORTC PATSAT has been especially modified to assess parents’ satisfaction with their children’s care.
- Finally, parents are asked to complete the Impact on Family Scale, a short questionnaire which tries to assess the impact a child’s medical condition can have on a family. It includes items on financial impact, familial and social impact as well as personal impact. It has been chosen because it has been previously used to assess the impact of childhood cancer on families.
All of the PROs described in this article have been developed by leading institutions and have been used widely by clinicians and researchers in the area of cancer with success for a number of years. This means that cancer patients have found them not only easy to use but also relevant to their experience and the specific issues they are facing. A key factor to the MyPal team’s selection of the PROs described is the fact that these questionnaires had already been translated in different languages and used in different cultural contexts. Most importantly, the presented PROs were chosen because it was possible for the MyPal team to take their traditional print format and adapt them into a digital format to suit the purpose of the MyPal project.
Dr Christina Karamanidou
Quality Assurance Officer, Foundation for Research and Technology - Hellas (FORTH), Greece