Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer

All patients receive standard treatment and care according to clinical guidelines and the protocol of the clinic where they are treated. This includes radiotherapy five days a week, with or without a combination of two sequences of brachytherapy, and regular contact with an assigned oncology contact nurse who can be contacted during office hours. The patients in the intervention group download the app onto their own smartphone or tablet; alternatively they may borrow such a device from the research group. They are instructed on how to use the app for reporting symptoms and start reporting in the app on their first day of radiotherapy. They then report daily, during weekdays, and three weeks following the last treatment. The total time for reporting is between eight to 11 weeks depending on whether the treatment is a combination treatment or not. The nurses at the clinic receive instructions and training on how to use the platform, including the alert system, and how to monitor the patients´ reports. Reporting in the app is a complement to the usual care and patients are encouraged to report before 3 PM as reports and alerts are managed during office hours (7 AM-4 PM). If emergency health care attention is needed the patients are instructed to contact the health care according to the standard procedure at the oncological clinic.

The prostate cancer version includes 14 symptom questions regarding bladder and bowel function, fatigue, pain, worry, depression, sleep, and flushing. They are included as a result of a literature review, interviews with patients and healthcare providers [ 25] and a feasibility study [ 49]. Furthermore, there is an open question, providing the patient with an opportunity to add comments; “Other symptoms or concerns to report?” Patients are asked about the symptoms’ occurrence, frequency, and distress level during the day, for example: “Do you experience urinary difficulties?” If the answer is yes, the patient is asked about the frequency, which can be rated as: almost never, sometimes, rather often, or very often. Next follows a question on distress level, which can be rated as: not at all, a little, somewhat, or very much. The symptoms of fatigue, insomnia, constipation and blood in stool are only assessed by the distress level and not by frequency. Specific symptoms are set to generate an alert to the registered nurses, via text messages (SMS), on appointed levels of frequency or distress. The level for each symptom has been decided based on a risk assessment model, in collaboration with clinicians. There are two kinds of alerts: yellow alerts that request a nurse to contact the patient during the day, and red alerts, requiring contact within one hour. Severe symptoms regarded as a potential risk for the patients’ health and well-being trigger a red alert. A symptom considered to be less severe triggers a yellow alert. The symptoms set to trigger alerts are: urinary urgency (very often; yellow alert), difficulties urinating (very often; red alert), haematuria (very often; yellow alert), diarrhoea (very often; yellow alert), blood in stool (very much; red alert), obstipation (very much; yellow alert), pain (very often; red alert) and depression, worry (very often; red alert).

All patients receive standard treatment and care according to clinical guidelines and the protocol of the clinic where they are treated. Standard treatment and care consist of neo adjuvant chemotherapy and regular visits to the physician and the oncology contact nurse prior to every treatment occasion. The patients in the intervention group download the app onto their own smartphone or tablet; alternatively they may borrow such a device from the research group. They are instructed on how to use the app for reporting symptoms and start reporting in the app on their first day of chemotherapy. They then report daily, during weekdays, and two weeks following the last treatment, alternatively until the day of surgery. The total reporting time is approximately 18 weeks. Reporting in the app is complementary to the usual care and patients are encouraged to report before 3 PM as the reports and alerts are managed during office hours (7 AM- 4 PM). If emergency health care attention is needed the patients are instructed to contact the health care according to the standard procedure at the oncological clinic.

The breast cancer version includes 14 symptom questions regarding fever, breathing difficulties, pain, nausea, vomiting, bowel function, oral problems, worry, depression, fatigue, insomnia, numbness/tingling in the hands and feet, and pain/swelling/redness in the arm (relating to the peripherally inserted central catheter line for chemotherapy administration). Furthermore, there is an open question providing the patient with an opportunity to add comments; “Other symptoms or concerns to report?” The questions were formulated based on extant literature and guidelines and subsequently pilot-tested on eight patients. Results from the feasibility study of the prostate cancer version were considered sufficient and thus no feasibility study was conducted for the breast cancer version. Patients are asked about the symptoms’ occurrence, frequency, and distress level during the day, for example: “Do you experience nausea?” If the answer is yes, the patient is asked about the frequency, which can be rated as: never, sometimes, rather often, or very often. Next follows a question on distress level, which can be rated as: not at all, a little, somewhat, or very much. The symptoms fever and pain/swelling/redness in the arm are only assessed by occurrence. The symptoms constipation, oral problems, worry, distress and insomnia are only assessed by the distress level and not frequency. Specific symptoms are set to generate an alert to the registered nurses via text messages (SMS) triggered by either occurrence, frequency or distress level. The level for each symptom was decided based on a risk assessment model, in collaboration with clinicians. There are two kinds of alerts: yellow alerts that request a nurse to contact the patient during the day, and red alerts, requiring contact within one hour. Severe symptoms regarded as a potential risk for the patients’ health and well-being trigger a red alert. A symptom considered to be less severe generates a yellow alert. The symptoms set to generate alerts are: fever (yes; red alert), pain/swelling/redness in the arm (yes; yellow alert) breathing difficulties, nausea and vomiting (rather often; yellow alert, very often; red alert) diarrhoea (very often; yellow alert), obstipation and worry (very distressing; yellow alert) and lastly oral problems (somewhat distressing; yellow alert).

Outcomes concerning HRQoL, symptom distress, perception of individual care, sense of coherence and health literacy will be collected through validated self-report questionnaires;

Medical data (morbidity, mortality, recurrence rate, biomarkers) will be obtained from medical journals, and socioeconomic data and health care costs (visits, pharmaceuticals) will be collected from medical registers up to six months after the intervention for a cost-effectiveness analysis of the intervention. Logged data on symptom reports and self-care advice accessed (adherence to the intervention) including frequencies of symptoms and generated alerts will be collected.

On to two weeks following the intervention all the patients in the intervention group are interviewed via telephone. Interviews are based on a semi-structured interview guide exploring the feasibility and acceptability of the app, the content of the self-care advice, and technical or other problems encountered when using the system.

Eighty patients (40 with breast cancer and 40 with prostate cancer) from both the intervention groups and the control groups will be interviewed face to face and individually about their experiences of participatory and meaningful care. The focus will be to explore how patients perceive their life situation in relation to the disease and how involved they felt in their care during the treatment. The interviews will be conducted three months after the end of treatment.

Health care professionals involved in the care of the patients in the intervention group will be interviewed via focus groups about their perceptions of the overall use of the mobile phone system and how the intervention might enhance participatory care. Special focus will be on symptom assessment and care interventions initiated because of the alert system, transfer of information and generation of alerts, and lastly the content and delivery of the self-care advice. We believe that the interaction between health care professionals in focus group interviews will give deep insights into the complexity of this phenomenon.