Keywords
breast cancer-related lymphedema - self-care - mobile applications - breast cancer
- smartphone
Background and Significance
Background and Significance
Breast cancer is the most common cancer and one of the most common leading causes
of death in females[1]
[2]
[3]
[4]
[5]
[6] with increasing incidence and mortality across the world.[7]
[8] About one-eighth of women experience breast cancer during their lifetime.[9] According to the Global Cancer Incidence, Mortality and Prevalence (GLOBOCAN), breast
cancer ranked first in incidence and second in the most common causes of cancer death
worldwide in 2020.[10] This cancer has been identified as the most common cancer and the fifth cause of
mortality in Iranian women.[8] According to the GLOBOCAN estimates, breast cancer accounted for approximately 13%
of new cancers in both men and women and 28% of cancers in women in Iran in 2020.[11]
Some breast cancer therapies, such as axillary lymph node dissection, can cause lymphedema
after treatment.[4] Lymphedema is a chronic, progressive, and debilitating complication and one of the
most common side effects of breast cancer treatment, which results from the fluid
accumulation in the interstitial tissue due to damage to the lymphatic system following
surgery, radiography, or tumor.[12]
[13]
[14]
[15] Breast cancer-related lymphedema (BCRL) symptoms impose high costs on patients and
increase their distress, reduce the quality of life (QOL), and lead to disability.[16] More than one-fifth of women who survive breast cancer develop lymphedema after
breast cancer treatment, affecting more than 40% of the three million breast cancer
survivors in the United States.[17]
Self-care is a very important issue in the management of chronic diseases.[18]
[19] Self-care programs play a critical role in controlling chronic diseases by improving
collaborative cooperation between patients and physicians, managing disease symptoms,
treatments, and patient lifestyle.[20]
[21]
[22] Lymphedema self-care behaviors are important to prevent further progression of the
disease and the severity of symptoms as well as its psychological and societal consequences.
Effective self-care in BCRL includes various behaviors that require continuous implementation
to minimize symptoms and slow the progression of the disease, some of which include
wearing a compression garment, proper exercise, hygiene and skin care, preventing
damage to the affected area and reducing the risk of infection, and maintaining a
normal body mass index.[23]
[24]
In recent years, adoption and widespread use of mobile phone technologies have opened
new horizons for improving health and providing health care.[19]
[25]
[26]
[27]
[28]
[29] Today, people are increasingly using mobile health (m-health) applications to manage
chronic illnesses, mental health, and fitness[30] because these apps can reduce self-care costs, increase care accessibility,[31]
[32] and improve the health outcomes, social support, and QOL of patients with chronic
diseases.[33]
[34]
[35]
The use of m-health apps makes it possible to perform routine assessments and effective
interventions that are key to self-care to improve the management of lymphedema symptoms[15]
[25] and access to health care for people with disabilities related to BCRL.[36] Due to the lack of definitive treatment for patients with lymphedema and the importance
of self-care in reducing the symptoms of the disease, teaching self-care strategies
via mobile apps can greatly reduce the risk of lymph fluid accumulation.[15]
[37]
[38] Long-term self-care reduces the effects of lymphedema on the patients' health status,
lessens the severity of inflammation, and ultimately prevents disease progression,
thereby reducing health care costs. In addition, the lack of care and treatment services
for these patients shows the importance of following self-care tips for patients with
BCRL; therefore, m-health is a key solution that can be used for all or some aspects
of their care.[39] However, the acceptance and satisfaction of the end users of an application is an
integral part of its successful implementation because the evaluation of usability
and user satisfaction makes it possible to redesign the application (if needed) to
ensure the benefits and leads to its success implementation.[40]
[41] In Iran, limited studies have focused on the design and use of mobile applications
for preventive measures and care of breast cancer patients.[42]
[43]
Objective
To the best of our knowledge, no mobile-based applications have yet been developed
to manage the symptoms of BCRL disease in Iran. Thus, a study was conducted to develop
a mobile app for self-care management of Iranian patients with BCRL and evaluate its
usability.
Methods
An applied developmental study was conducted to develop and test the usability of
a mobile application based on the Android operating system for self-care management
of Iranian patients with BCRL in 2020. This study was conducted in three main stages.
Stage 1: Pre-development (Information Needs of Patients and Experts, Content, and
Functions of the App)
The needs assessment survey was conducted from June 1 to June 30, 2020 to determine
the required information needs for the BCRL self-care mobile application from the
participants' perspectives (experts and patients).
The contents of the application were organized using a literature review. In this
stage, all publications until May 2020 were searched in PubMed and Scopus databases
for related clinical guidelines and medical literature. The applied search terms were
a combination of “breast neoplasm*” OR “breast cancer” OR “Breast Cancer Related Lymphedema”
OR “Breast Cancer Lymphedema” OR “Breast Cancer Lymphedema” OR “Post-mastectomy Lymphedema”
OR “Breast Cancer-Related Arm Lymphedema” OR “Breast Cancer Treatment-Related Lymphedema”
AND “Smartphone Apps” OR “Mobile Apps” OR “Mobile Applications” OR “Portable Software
Apps” OR “Portable Electronic Apps” OR “Portable Software Applications” OR “Portable
Electronic Applications.”
The inclusion criteria were full-text articles in English language related to the
research topic. The articles published in languages other than English, the articles
whose full-text were impossible to access, reports and forms retrieved from personal
weblogs, and letters to editors were excluded from the study. A total of 220 papers
were extracted of which 27 papers were duplicates and were therefore removed. Of the
193 remaining papers, 156 and 27 articles were excluded after reviewing their titles
and abstracts, respectively. The remaining 10 papers were scrutinized for eligibility,
and all of them met the inclusion criteria.[21]
[44]
[45]
[46]
[47]
[48]
[49]
[50]
[51]
A questionnaire was constructed to determine the information content and functions
of the mobile-based self-care application for patients with BCRL based on literature
review. The questionnaire was composed of four main parts, including (1) the participants'
demographic characteristics (i.e., age, marital status, and education for patients
and age, gender, work experience, work experience in lymphedema clinic, and specialist
field for experts), (2) 14 and 21 administrative and clinical information, (3) 19
items about lifestyle educational needs, and (4) 35 items concerning the functions
(i.e., drug use, nutrition, communication, exercise, smoking cessation, and test time
reminder) for participants (patients and experts). At the end of each main section,
an open-ended question was considered so that participants could add their suggested
data elements other than those in the questionnaire. The questionnaire was composed
of three columns with ‘‘necessary’' and ‘‘unnecessary’' in front of each data element.
The participants were asked to determine the necessity of the data elements and functions
proposed in the app.
The content validity of the questionnaires was evaluated by six experts, including
three PhD holders in health information management and three PhD holders in medical
informatics. The criteria for selecting experts at this step included knowledge and
experience in designing self-care management applications and publishing at least
one scientific article in this area. The Kuder and Richardson Eq. 20 (KR20) was used
to estimate the reliability of the questionnaires. Cronbach's α coefficients were
0.72 and 0.74 for the patients and experts' questionnaires, respectively.
Purposive sampling was used to select 30 experts (i.e., six vascular surgery specialists,
five breast surgery specialists, six gynecologists, six oncologists, six physiotherapists,
and a psychologist).The criterion for the selection of experts was knowledge and experience
about lymphedema. Convenience sampling was used to select 30 patients with BCRL presenting
to two teaching hospitals (i.e., Rasul-e Akram and Firoozgar) affiliated with Iran
University of Medical Sciences. The criterion for the selection of patients was a
positive history of breast cancer. The criterion for the acceptance of data elements
in the app was set by the researchers, so that if 75% or more of the participants
(patients and experts) on average considered an item as necessary, the item was included
in the app.
Stage 2: Design and Translation of Pre-development Output into an Android-Based Mobile
Application
In this stage, the conceptual modal of the app was designed by drawing unified modeling
language (UML) diagrams. Microsoft Visio ver. 2019 was used for illustrating UML diagrams.
Then, the mobile app was designed and programmed using the Android Studio environment
and Java programming language for Android devices. SQLite was used to design the application
database. The main menus of the BCRL self-care app consist of four demographic information,
clinical information, system functions, and life style sections ([Fig. 1]). In the patient demographic information section, the users enter their demographic
data (i.e., patients' name, family name, age, sex, education, employment status, height,
weight, attending physician name and surname, etc.). The clinical data section of
the application includes 21 data, such as history, symptoms, duration, and severity
of the disease, drugs used, drug sensitivities, medical procedures (including chemotherapy,
radiotherapy, and hormone therapy), the number and type of surgical procedures performed,
type of lymph node inflammation, number of involved lymph nodes, number of lymph nodes
removed, the average change in arm volume, and midwifery care and recommendations
([Table 1]).
Fig. 1 The main menu of the BCRL self-care app. BRCL, breast cancer-related lymphedema.
Table 1
Frequency distribution of participants' responses regarding the necessity of proposed
administrative and clinical data elements
|
Category
|
Data elements
|
Respondents
|
Necessary
|
Unnecessary
|
|
N
|
%
|
N
|
%
|
|
Administrative data elements (n = 14)
|
Patient name
|
Experts
|
22
|
73
|
8
|
27
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Patient last name
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Patient marital status
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
20
|
67
|
10
|
33
|
|
Employment status
|
Experts
|
13
|
43
|
17
|
57
|
|
Patients
|
21
|
70
|
9
|
30
|
|
Being the head of the household
|
Experts
|
15
|
50
|
15
|
50
|
|
Patients
|
21
|
70
|
9
|
30
|
|
Education level
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
22
|
73
|
8
|
27
|
|
Number of children
|
Experts
|
13
|
43
|
17
|
57
|
|
Patients
|
21
|
70
|
9
|
30
|
|
National ID code
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Age
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Weight
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
22
|
73
|
8
|
27
|
|
Hight
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Name and surname of the attending physician
|
Experts
|
12
|
40
|
18
|
60
|
|
Patients
|
23
|
77
|
7
|
23
|
|
Patient address
|
Experts
|
17
|
57
|
13
|
43
|
|
Patients
|
10
|
33
|
20
|
67
|
|
Phone number
|
Experts
|
22
|
73
|
8
|
27
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Clinical data elements (n = 21)
|
Disease history
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Disease symptoms
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Duration of illness
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Names of medications being taken
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Dosage of drugs taking
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Disease stage (e.g., stage 1, stage 2, or stage 3)
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
History of radiotherapy (radiation therapy)
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
History of chemotherapy
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
History of hormone therapy
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Family history of breast problems
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
29
|
97
|
1
|
3
|
|
History of severe trauma or injury to the organ involved
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
History of infection at the surgical site
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
History of drug allergy
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Type of breast cancer surgery
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Type of lymph node inflammation
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Type of lymph node surgery
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Number of affected lymph nodes
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Number of lymph nodes removed
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Average change in arm volume
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Underlying disease
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Midwifery care and advice
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
24
|
80
|
6
|
20
|
The lifestyle section contains self-care recommendations on nutrition, physical activity,
smoking, stress, ways to prevent and control lymphedema, post-surgical care, health
tips for lymphedema, how to use lymphedema drugs, possible complications of lymphedema
drugs, importance of regular use of drugs, expression of drug interactions, and necessary
actions when forgetting to use medications ([Table 2]). The application includes the following six functions ([Fig. 2]).
Fig. 2 The main functions of the BCRL self-care app. BRCL, breast cancer-related lymphedema.
Table 2
Frequency distribution of participants' responses about the lifestyle educational
needs of the application
|
Lifestyle educational needs
|
Respondents
|
Necessary
|
Unnecessary
|
|
N
|
%
|
N
|
%
|
|
Definition of lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Prevalence of lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Causes and risk factors of lymphedema
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Symptoms of lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Diagnosis of lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Complications of lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Treatment of lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
27
|
90
|
3
|
10
|
|
The effect of exercise on lymphedema
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
25
|
83
|
5
|
17
|
|
The effect of nutrition on lymphedema
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
27
|
90
|
3
|
10
|
|
The effect of smoking on lymphedema
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
27
|
90
|
3
|
10
|
|
The effect of stress management on lymphedema
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Ways to prevent and control lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Postoperative breast care
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
29
|
97
|
1
|
3
|
|
Health tips for lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Patient knowledge of how to take drugs
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
23
|
77
|
7
|
23
|
|
Complications of medications/drugs
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
The importance of regular medication taken
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Expression of drug interactions
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Necessary measures when forgetting to take medications
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
21
|
70
|
9
|
30
|
Drug use management: The patients can enter the names of the drugs and their dosage, the number of drugs
provided, the start and end dates of the period of use, the side effects of the drugs,
and a reminder for drug use. The patients can enter their daily consumption until
the end of the treatment period and then complete the treatment period through the
option “finish consumption and calculate the forgotten number” to see the number of
forgotten drugs.
Nutrition management: This function consists of two subfunctions. The calorie calculation subfunction
enables the patients to estimate the required daily calorie by entering the gender,
age, height, and weight and selecting the amount of daily activity. In the food management
subfunction, the patients can enter the days of the week they are on a diet and then
select their daily food consumption from a list of available foods as well as its
amount using appropriate units (grams, number, and glasses). The application then
displays the daily calorie intake in general and also the calorie intake for each
food per 100 g, the number of calories consumed, and the amount of consumption of
each food selected by the user separately so that the patients can compare their calorie
intake with the number of calories they need.
Smoking cessation management: This function comprises two subfunctions. Logging into the cessation planning subfunction
enables the users to enter the number of cigarettes smoked per day, price of each
cigarette, duration of smoking in years, and the desired target in terms of the number
of cigarettes smoked per day. Besides, logging into the cessation management section
allows the patients to enter the name of each month after which the list of that month
is shown and the purpose for each day is displayed in this section; hence, the patients
can select the number of cigarettes they smoke per day and compare their use with
the target number.
Exercise management: This function consists of four subfunctions. In the starting exercise section, sports
movements are divided into three categories: stretching movements of BCRL, movements
after breast surgery, and yoga moves. By logging into each of these sections, the
patients can view a list of their movements. Then, they can select different movements
by clicking on its image. Moreover, they can activate a 3-minute timer by selecting
the start option at the bottom of the screen. In the daily exercise time section,
the patients can enter the duration of their exercise on a daily basis in hours and
minutes. In the daily activity chart section, the patients can view the daily activity
chart of the week separately for each day and the duration of exercise by selecting
the desired week. Furthermore, in the daily reminder section, the users can activate
the daily exercise reminder by selecting the exercise reminder time in hours and minutes
and activating the daily reminder option.
Communication/contact: This function includes four subfunctions. In contact with the doctor section, the
patients can search the name of the desired doctor. In the patient contact section,
the users can view and search the patients' names along with their contact numbers.
In communication with the pain clinic section, a list of pain clinics located in Tehran
city along with their addresses and telephone are available which can be used by patients
to contact them if necessary. In the reminder for appointment with the doctor section,
the patients can record a new reminder by selecting the date, time, and name of the
doctor.
Test time reminder: In this function, the patients can record a new reminder by selecting the date and
name of the test.
Stage 3: Usability Testing of Application
In this stage, 30 patients with a history of lymphedema presenting to the Lymphedema
Clinic of Motamed Cancer Institute, Tehran, Iran were selected through convenience
sampling to assess the usability of the application. This center is a referral clinic
and accepts patients from other provinces of Iran.[52]
The participants were individually contacted and provided with information about the
app and the ultimate aim of its development. Informed consent was obtained from all
patients prior to participation in the study. Since the app was developed only on
an Android platform, the main criterion for patients entering this stage was access
to phones with the Android operating system. Then, the application along with its
installation guide was sent to the participant's mobile phones. After confirming the
successful installation of the application, they were asked to use the application
for 2 weeks. To ensure that the patients use the application, a daily message with
the content “please use the application” was sent to them and they were asked to give
feedback on their daily use of the application.
The usability of the app and the users' satisfaction with the interface were evaluated
using QUIS Version 7 developed by a multi-disciplinary team of researchers in the
Human–Computer Interaction Laboratory at the University of Maryland, College Park.
Due to the translation of the original questionnaire into Persian language, we re-evaluated
the validity and reliability of the Persian version. The questionnaire consists of
two main parts: (1) The users' demographic characteristics (i.e., age and education
level) and (2) 32 questions divided into six factors including overall reaction to
software (n = 6), screen design and layout (n = 4), terminology and system information (n = 6), learning (n = 6), system capabilities (n = 5), and usability and user interface (n = 5). The Part B of the questionnaire was scored on a 10-point scale from zero to
nine. After calculating the mean score of the measured factors, the following divisions
were used to evaluate the level of the users' satisfaction. A mean score of 6.1 (out
of nine) or higher indicated a good level of satisfaction. Besides, a mean score of
3.1 to 6 showed average satisfaction, and a mean score of 3 or lower indicated a weak
level of satisfaction.
Statistical Analysis
The SPSS for Windows ver. 22.0 was used for data analysis. Descriptive statistics
(number, percentage, mean, and standard deviation) are used to present general characteristics
(e.g., age, education level, occupation, and work experience, etc.) as well as the
usability responses of experts and patients.
Results
Predevelopment Stage Findings Participants' Demographics
The experts participating in the needs assessment phase included 30 experts with experience
in the lymphedema department. Fifty-three percent of the them were male and the rest
were female. Half of the experts were over 50 years old and had more than 25 years
of work experience. The majority of them (70%) had more than 5 years of experience
in the field of lymphedema. The highest frequency of experts was related to specialists
of vascular surgery, gynecologists, oncologists, and physiotherapists (20% each) followed
by breast surgery specialists (17%) and psychologists (3%). The patients participating
in this stage included 30 women with lymphedema after treatment for breast cancer.
More than half of them had a high school diploma or lower degrees (53%) followed by
associate degree (30%) and bachelor's degree (10%). Only 7% of the patients had a
master's degree or higher. Furthermore, the highest frequency of age range was related
to the age group 50 to 59 years (53%) followed by 60 to 69 (27%) and 40 to 49 (13%)
years. Only 7% of the patients were 30 to 39 years old.
The participants identified nine administrative data elements as necessary and five
data elements as unnecessary (i.e., patient's employment status, number of children,
address, being head of household, and name and surname of attending physician). Besides,
they recognized all of the 21 clinical data elements as necessary. No new data elements
were proposed by the participants ([Table 1]).
All lifestyle educational needs were recognized as necessary from the participants'
perspective ([Table 2]).
According to [Table 3], the participants identified one function as unnecessary (i.e., send hopeful and
reassuring sentences as a message to the patient's cell phone). Besides, the participants
suggested one new function (i.e., introducing different types of diets). The necessity
of the data element was inquired from all participants, of whom more than 75% considered
it as necessary.
Table 3
Frequency distribution of participants' responses about the required functions for
the application
|
Functions needs
|
Respondents
|
Necessary
|
Unnecessary
|
|
N
|
%
|
N
|
%
|
|
Reminder time to take medication
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Entry of medications
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Entry of complications caused by medication
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Entry of the dose of the drug
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Display the number of times the drug is forgotten at different time intervals
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Show forgotten drug name
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Entry of the number of drugs provided
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Proper diet planning
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Entry of fluid intake
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Determine the calories of food consumed
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Entry of the amount of food consumed in each meal
|
Experts
|
23
|
77
|
7
|
23
|
|
Patients
|
25
|
83
|
5
|
17
|
|
Compare the nutritional status with the set goal and show it to the patient
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Communicate the patient by contacting your doctor.
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Set an online appointment with physician
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Send entered information to the doctor
|
Experts
|
29
|
97
|
1
|
3
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Communicate in the form of messages and contacts with other patients
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
29
|
97
|
1
|
3
|
|
Remind the patient time to meet with the treating physician
|
Experts
|
28
|
93
|
2
|
7
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Contact the pain clinic
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Plan to do regular exercise and physical activity to control illness and overcome
stress
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
26
|
87
|
4
|
13
|
|
Entry of the duration of physical activity
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Show a graph of the progress of physical activity in improving the patient's condition
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Exercise reminders
|
Experts
|
22
|
73
|
8
|
27
|
|
Patients
|
28
|
93
|
2
|
7
|
|
Planning to smoking cessation
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
22
|
73
|
8
|
27
|
|
Entry of the number of cigarettes consumed per day
|
Experts
|
25
|
83
|
5
|
17
|
|
Patients
|
22
|
73
|
8
|
27
|
|
Displays the number of cigarettes consumed at different time intervals
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
23
|
77
|
7
|
23
|
|
Compare the number of consumed cigarettes in each month with the previous months
|
Experts
|
24
|
80
|
6
|
20
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Reminders to perform diagnostic tests and imaging
|
Experts
|
22
|
73
|
8
|
27
|
|
Patients
|
27
|
90
|
3
|
10
|
|
Registration of complications and problems associated with lymphedema
|
Experts
|
22
|
73
|
8
|
27
|
|
Patients
|
21
|
70
|
9
|
30
|
|
Search for educational content related to lymphedema
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
20
|
67
|
10
|
33
|
|
Provide addresses and contact telephone numbers of specialist physicians
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
22
|
73
|
8
|
27
|
|
Search for doctors' addresses
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
20
|
67
|
10
|
33
|
|
Search for medical centers
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
21
|
70
|
9
|
30
|
|
Send hopeful and reassuring sentences as a message to the patient's cell phone
|
Experts
|
26
|
87
|
4
|
13
|
|
Patients
|
16
|
53
|
14
|
47
|
|
Technical support
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
22
|
73
|
8
|
27
|
|
Use the application usage guide
|
Experts
|
27
|
90
|
3
|
10
|
|
Patients
|
24
|
80
|
6
|
20
|
|
Introducing different types of diets
|
Experts
|
23
|
77
|
7
|
23
|
|
Patients
|
27
|
90
|
3
|
10
|
Development and Implementation of Phase Findings
The application was developed in the Android software platform. The app menus were
divided into four main parts, including demographic information, clinical information,
lifestyle, and system functions ([Fig. 1]).
The app consists of six functions of drug use management, nutrition management, exercise
management, smoking cessation management, and test time reminder ([Fig. 2]). Besides, pilot implementation of the developed app was done at this stage. Participants
were asked to install the application on their cell phones. The patients were required
to use the application for 2 weeks from September 1 to 14, 2020.
Usability Testing Findings
All participants completed the questionnaires at this stage of study. The highest
mean scores of the app usability were achieved in “screen design and layout” and “system
capabilities” areas with 8.5 ± 0.56 and 8.5 ± 0.55, respectively. Moreover, the lowest
mean score was founded in the terminology and system information area with 7.61 ± 1.16.
However, all mean usability evaluation scores of the assessed areas were between 6
and 9, which indicates that the usability of the application was evaluated at a good
level from the patients' perspective ([Table 4]). However, the patients were less satisfied with the terminology and information
of the system compared with other evaluated areas, which should be taken into consideration.
In this regard, considering the two components “program messages to complete user
tasks” and “screen message to record necessary data” because of obtaining a lower
average score from the patients' point of view compared with the other four components
of this area, seems necessary.
Table 4
Usability evaluation of the app by patients
|
Row
|
Assessment areas
|
Mean ± SD
|
|
1
|
Overall reactions to the app
|
8.36 ± 0.63
|
|
2
|
Screen design and layout
|
8.5 ± 0.56
|
|
3
|
Terminology and systems information
|
7.61 ± 1.16
|
|
4
|
Learning
|
8.32 ± 0.79
|
|
5
|
System capabilities
|
8.5 ± 0.55
|
|
6
|
Usability and user interface
|
8.2 ± 0.48
|
Abbreviation: SD, standard deviation.
Note: All questions were scored in a range of 0 to 9.
Discussion
The BCRL app was developed based on two main stages and its usability was evaluated
by the patients. In the first stage, using a literature review and needs assessment
survey from experts and the patients, the content and functions of the app were determined.
In the second stage, design and translation of pre-development output into an android-based
mobile application was done. In the third stage, the usability of the app was evaluated
from the patient's perspective.
Management of the QOL of patients with lymphedema, as a chronic progressive debilitating
condition, following breast cancer plays a key role in managing care and reducing
its consequences,[14] which can improve the clinical outcomes and QOL of the patients.[53] In the designed application, lifestyle, diet, smoking, exercise, and daily activities
management functions enable patients to promote self-care management, which leads
to improved care management and QOL. Similar to our findings, Temur and Kapucu[24] revealed that exercise and massage activities through a self-care program have a
positive effect on preventing the progression of lymphedema after breast cancer treatment.
Furthermore, the sections of the designed app in our study were similar to the functions
in the study by Taheri et al[54] for the self-care of cancer patients undergoing chemotherapy and contained clinical
information, lifestyle, and medication reminders sections.
Shahsavari et al[55] found that self-care educational programs improved the QOL of breast cancer patients.
In addition, Temur and Kapucu.[24] showed that 61% of the patients with lymphedema who did not receive the necessary
self-care training experienced disease progression, and patients who received training
had higher QOL and fewer symptoms, which indicate the educational needs of the patients
and the importance of self-care education. The present study answered many educational
needs related to physical and mental self-care. Patient education is one of the most
effective principles for the management of BCRL.[14] Educating patients by health care professionals can increase the effectiveness of
self-care management[56]
[57] and decrease the economic, social, and psychological consequences of BCRL.[58] Patient education function included in the developed application empowers the patients
to perform exercise and daily activities and control the BCRL symptoms. Functions
of our developed app are relatively similar to the app designed by Hou et al,[21] which has treatment, physical activity, diet, emotional support, health records,
social resources, experience sharing, and expert consultation sections.
Ostby and Armer[59] found that complex congestive therapy, symptom burden, right time for treatment,
and lack of patient education and support could seriously affect their self-management
of BCRL condition. The drug management functionality of the designed application encourages
the patients to adhere to the drug consumption and thus reduces the burden of psychological
and physiological symptoms of BCRL.
The results of a study conducted by Luz et al[60] showed that strengthening exercise can be performed by patients with lymphedema
without worry or risk of increased upper limb volume. In the self-care application
of BCRL, some exercises are also presented as training examples, which help the patients
through providing examples and reminding them of performing the exercises. Shaw et
al[61] compared the effectiveness of two types of dietary interventions on arm volume in
patients with lymphedema after breast cancer treatment and found that weight loss
by any method could be useful in treating lymphedema associated with breast cancer.
The developed application also included nutrition tips and tutorials and diet planning.
Thus, the application has the potential to relieve the symptoms of the BCRL condition.
Similar to the app designed by Lozano-Lozano et al,[50] which focused on monitoring healthy lifestyles in cancer survivors based on the
two functions of diet and physical activity, the app designed in the present study
also has nutrition management and exercise management functions which can lead to
a healthier lifestyle for patients and prevent the progression of disease symptoms.
However, the app designed in our study has more functions than the app designed by
Lozano-Lozano et al. This difference can be explained through the purpose of designing
apps in these studies.
Fu et al.[15] found that mobile-based systems have the potential to manage the pain and symptoms
associated with lymphedema. The results of the present study revealed that the patients
considered the app as a valuable and satisfactory tool for supporting self-care management
of BCRL. However, complete evaluation of the effectiveness of app in the self-care
management of BCRL symptoms requires the implementation of the app in a wider community
of patients over a longer time.
Usability evaluation showed that the application was good from the patients' perspective.
Our findings were in line with previous studies that have been conducted on the design
and development of breast cancer-related self-care management applications.[15]
[46]
[54]
[62] Adopting a socio-technical approach could increase the usability and acceptance
of mhealth applications because a techno-centric factor without consideration of socio-technical
factors could negatively affect users' engagement.[47]
[63] Considering human factors in the designing of health information technology (IT)
can help understand the needs of stakeholders and design health IT interfaces that
are customized to their needs and therefore play a pivotal role in the more usable
and safer health IT.[41]
[63]
[64]
[65]
[66] Furthermore, the ergonomic factor in the design of mobile-based applications also
has a vital influence on the practical convenience of use and acceptance of applications
by users.[63]
[67]
Study Limitations
Lymphedema can develop following treatment for several cancers such as breast, head
and neck, and female genital cancers. This study focused solely on designing an application
to manage the symptoms associated with breast cancer-related lymphedema. Thus, the
findings can be generalizable only to the target community. The lack of comparison
between the designed app and the applications available in the Play Store and the
App Store is one of the other limitations of this study because if there is such a
comparison, it could help to improve the usefulness of the designed app. In addition,
in this study, application usability evaluation was performed by a limited number
of patients. It is suggested that the usability of the application be evaluated in
a larger sample of patients with BCRL so that a more comprehensive and accurate judgment
can be made about its usability.
Conclusion
The BCRL app provides educational, nutritional, drug use, exercise management, and
lifestyle functions for patients with BCRL and has the potential to improve patients'
lifestyle, education, symptom management, and the continuation of self-care and treatment
measures, access to information to enhance self-care management and promote the QOL
of Iranian patients with BCRL. The mobile app was found to be appropriate in terms
of the overall reactions to the app, screen design and layout, terminology and system
information, learning, app capabilities, and usability and user interface from the
end users' (patients') perspective. It is suggested that further studies be performed
to confirm the effectiveness and identify the clinical significance of the app.
Clinical Relevance Statement
Clinical Relevance Statement
Breast cancer is the most common life-threatening cancer in females with increasing
incidence and mortality worldwide. Lymphedema is one of the most common side effects
of breast cancer treatment. Mobile-based self-care management applications make it
possible to perform routine assessments and effective interventions that are key to
self-care to improve the management of lymphedema symptoms. The developed mobile app
for BCRL in Iran is recognized as an appropriate tool for improving the patients'
lifestyle and education and self-management of BCRL symptoms according to its usability
evaluation from the patients' perspective.
Multiple Choice Questions
Multiple Choice Questions
-
Which of the following users is the main user of BCRL application?
-
Patients.
-
Physicians.
-
Policy-makers.
-
Patients' family.
Correct Answer: The correct answer is option a. The main users of the BCRL application are patients
with BCRL condition.
-
What is the main application of the BCRL application?
Correct Answer: The correct answer is option d. The main purpose of development of the BCRL application
is self-care management in patients with BCRL condition.
-
Application of BCRL is designed to manage the symptoms of which of the following cancers?
-
Lung cancer.
-
Lymph node cancer.
-
Breast cancer.
-
Skin cancer.
Correct Answer: The correct answer is option c. The BCRL application was designed to improve the
management of lymphedema symptoms of breast cancer treatment.
