Study Design and Setting
The study was conducted in a state hospital in Turkey, between January 2018 to July 2018. A single-blinded, single-centered and randomized design were used. This study was registered at the ClinicalTrials.gov (register number: NCT04315012). Ethical Committee Permit (The Ethics Committee of the University of Balıkesir, 2017/143) and institution permit were received for this study. Participants were randomly assigned to either control group that receives routine care or intervention group that receives routine care plus access to mobile app–based training support for 12 weeks (Figure 1). Moderated by an specialist nurse, the mobile app- based training program supported women with breast cancer for 12 weeks. QOL and symptom distress were measured before intervention (T0), after 12 weeks (T1) of intervention.
Figure 1.
This study is the application of three modality combinations:
(1) Mobile app-based patient education: Based on a literature research with respect to the subject matter; health care needs and coping methods were determined for the symptom management of women with breast cancer using adjuvant EHT (Picture 1). The Mobile app- based training provides 8 topics on symptoms management for problems in EHT including 1) how to deal with hot flashes / night sweats; 2) vaginal dryness, itching and bleeding management; 3) fatigue management; 4) how to deal with mood changes; 5) pain management; 6) sleep management; 7) how to deal with sexual ıssues; 8) how to deal with upper limber lymphoedema. Mobile app-based training also provides basic information about breast cancer, treatment options, symptom diary and lifestyle recommendations (adequate and balanced nutrition, regular physical activity, deal with stress effectively). The mobile app- based training included NCCN Distress Management algorithm 17, 18. Distress levels of patients involved in study and their reasons were determined and information related to distress management (“coping with stress”, “effective changes-recommendations”, “healthy lifestyle recommendations”) was included in the app. Out of the recommendations; providing training for the patients regarding the disease, coping methods such as relaxation techniques (relaxation exercises CD of 30 minutes which include breathing and muscle exercises) and guided imaginary were installed in the app. The guided imaginary CD contained natural views accompanied by relaxing, restful, slow music of 12 minutes oriented for the oncology patients.
Picture 1.
(2) Web-based management application: This program is where user information and logins are commanded, monitored, consulting activities are managed (question, answer, reminder) by mobile app manager (an specialist nurse). Questions, opinions, and report of symptoms sent by the participants over the mobile app were answered. In addition, participants were informed in a timely manner by a specialist nurse from the web-based app panel. Regarding this, many reminder messages have been sent to participants for any advice about self-care and supportive care. The researcher collaborated with a multidisciplinary team (medical oncologist, radiation oncologist, psychologist, oncology training nurse, radiotherapy training nurse, physiotherapist, dietician).
(3) Nurse’s tracking over the phone and mobile app: By arranging one-to-one phone calls every two weeks between a specialist nurse and a participant; counseling was provided on patients’ problems with the mobile app, with EHT, QOL, and their symptoms stated in the symptom diary and results of monitoring.