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.