Effects of Health Belief Model Based Nursing Interventions Offered at Home Visits on Lymphedema Prevention in Women With Breast Cancer: A Randomized Controlled Trial
Phase: NA
Conditions: Breast Cancer, Breast Cancer Lymphedema, Home Visit
Sponsor: Ayse Cal

 
 
 
 
 
Effects of Health Belief Model based nursing interventions offered at home visits on 
lymphedema prevention in women with breast cancer: A randomized controlled trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13.07.2017 

Backround 
Secondary lymphedema is one of the most severe complications resulting from damage to 
lymphatic drainage due to breast cancer treatment. Many women suffer from lymphedema after 
breast cancer treatment. Due to the lack of standard diagnostic criteria for the incidence of 
lymphedema varies from less than 5% to more than 50%.  In a recent meta-analysis, it has been 
found to be 21.4%.  
The primary risk factors of lymphedema are lymph node involvement and axillary lymph 
node dissection. The other risk factors are radiotherapy, adjuvant chemotherapy, early 
postoperative swelling, body mass index, advanced age, insufficient physical activity, 
infections in the affected arm and injuries. A study performed axillary dissection in women 
with breast cancer and found that 13.4% of the women not receiving radiotherapy and 42.4% 
of the women receiving radiotherapy had lymphedema.  
Lymphedema reduces the quality of life due to physical and psychosocial disorders it 
creates.  Women with lymphedema have physical problems such as restricted movements, 
retraction, weakness, pain and swelling on the affected breast and arm, difficulty in maintaining 
daily life activities and psychological problems like low self-confidence, disappointment, 
sadness and fear due to the appearance of lymphedema.   
It has been reported that the yearly cost of treatment (visits to therapists and compression 
garment) per person is $977 for lymphedema, $277 for subclinical lymphedema, higher than 
$1400 for moderate and severe lymphedema. Effective management of lymphedema on the 
affected arm could reduce negative effects of lymphedema and resultant high treatment costs.  
Nurses believed that risk reduction (95%) and self-management (68%) were the 
responsibility of nursing while 69% felt that management of lymphedema was the responsibility 
of a different discipline, such as lymphedema therapy. The patient-centered educational and 
behavioral program delivered by trained nurses is effective to enhance lymphedema risk 
reduction. Lewis and Morgan emphasized that cooperation with public health nurses improves 

patient care outcomes and costs associated with lymphedema management. At this point, the 
literature suggested that nurses should inform individuals about the risk of lymphedema after 
breast cancer. 
It has been shown in the literature that women are not aware of lymphedema before its 
development, are unable to recognize its symptoms and can not take sufficient preventive 
measures. Similar to the aims of the present study, Zhou et al. examined effects of a 
comprehensive Health Belief Model (HBM) based nursing care program on the quality of life, 
lymphedema and other complications after breast surgery in their randomized controlled study 
on women in 2016. 
The conceptional framework most frequently used to explain health behavior and to help 
patients to acquire this behavior is HBM. The model describes what motivates people to exhibit 
or not exhibit health behavior and especially what conditions are effective at this behaviors. 
The results of the present study, using HBM, will contribute to determination of beliefs and 
attitudes likely to create problems with adoption of behavior preventing lymphedema and 
selection of nursing interventions performed to manage the condition. Chronicity of 
lymphedema, likely to appear in the long-term, and its potential to affect the quality of life 
indicate that individuals with breast surgery have home care needs. 
Study Protocol 
Aims  
The aim of this study was to examine effects of HBM based nursing interventions offered at 
home visits on lymphedema development in women undergoing breast surgery. 
Study design and setting  
The study had a single-blind, randomized controlled experimental design. To avoid bias, the 
participants were not told whether they were in the experimental or the control group. The 
conceptual structure of the study is given in Figure. This randomized clinical trial was based on 

the guidelines proposed by the Consolidated Standard of Reporting Trials – CONSORT 2010. 
The study was conducted at homes of patients receiving treatment for breast cancer at a hospital 
and living in Samsun, a city in northern part of Turkey , between May 2016 and April 2017.  
Inclusion criteria 
The study population included individuals receiving radiotherapy after breast surgery. Inclusion 
criteria were diagnosis of primary breast cancer and having stage I, II and III, having axillary 
dissection, not having the diagnosis of lymphedema, receiving radiotherapy, volunteering to 
participate in the study, age over 18 years and female and residing in the city.  
Non-inclusion criteria and exclusion criteria  
Exclusion criteria were diagnosis of bilateral breast cancer, open wound or infection in the 
upper extremities, musculoskeletal disorders preventing movements of the upper extremities, 
ongoing adjuvant systemic chemotherapy. 
Randomization 
 An intervention group and a control group were formed by using the research randomizer 
software.  The program used random numbers to select participants and randomly assign them 
to the experimental or control group (100 participants were assigned to each group). 
Homogeneity test showed no significant difference between the measures of the groups in Table 
1 (p>.05).  
Blinding of data collectors and the statistician was implemented in this randomized 
blinded study. Another researcher who did not know the group assignments coded the data in 
the computer. After statistical analysis was conducted and the research report was written, the 
assistant researcher explained the codes for the experimental and control group. Therefore, 
blinding of data collectors, statistical analysis, and report writing was provided. 
Study outcomes  

Personal Information Questionnaire;The questionnaire, developed by the researchers, is 
composed of 17 questions about sociodemographic characteristics, diagnosis and treatment of 
breast cancer, behavior of lymphedema prevention. 
Quick-Disabilities of the Arm, Shoulder and Hand Score;Q-DASH is used to 
determine severities of disabilities in the upper extremities and benefits gained from 
treatment. It was adapted…by Duger et al. and its cronbach’s alpha was reported to be .91. It 
is a five-point likert scale and includes 11 questions. The score zero indicates lack of a disability 
and 100 the most severe disability.  
Strategies Used by Patients to Promote Health;SUPPH is a self-report scale created by 
Lev and Owen to evaluate self-efficacy of individuals in development of health promotion 
strategies. It was adapted by Akın and its Cronbach’s alpha was reported to be .92.  The scale 
consists of 29 items. The subscale stress reduction includes the items 1-10, making decision the 
items 11-13, positive attitude the items 14. Each item is scored from one to five:one corresponds 
to very little and five very much. The lowest and the highest scores for the scale are 29 and 145 
respectively. Higher scores show higher levels of self-efficacy in self-care behavior 29.  
European Organization for Research and Treatment of Cancer Quality of Life Scale for 
Breast Cancer 23;EORTC QLQ-BR23 was developed from European Organization for 
Research and Treatment of Cancer Quality of Life Scale 30 by EORTC to measure the quality 
of life in individuals with breast cancer. It was adapted Turkish by Demirci et al. The scale is 
composed of 23 items, a four-point scale and has two scales named FS and SS. Cronbach’s 
alpha was reported to be .88 for the FS .66 for the SS. The FS has the subscales body image 
(items 39,40,41,42), sexual functions (items 44,45), sexual satisfaction (item 46), worry about 
the future (item 43). The SS has the subscales side effects of systematic treatment (items 
31,32,33,34,36,37,38), breast symptoms (items 50,51,52,53), arm symptoms (items 47,48,49), 
worry about hair loss (item 35). The lowest and the highest scores for each scale are zero and 

100 respectfully. Higher scores for the FS show a higher quality of life and higher scores for the 
SS indicate a poorer quality of life. 
To calculate scores for the FS and the SS, the total score for the items of each scale is 
divided by the total number of items and the following formulae are used:FS={1-((((total score 
for the items)/number of items)-1)/range)}x100 and SS={(((total score for the items)/number 
of items)-1)/range}x100. The highest and lowest score for the items are four and one and the 
difference between them, that is, three, refers to range.  
Arm Circumference Measurement Form;The form was made on four different sites on 
both arms:at the dorsum of the hand, the wrist, and 10cm below and above of the elbow. The 
difference more than 2cm between circumferences of the arms was considered as significant 
in terms of lymphedema. 
Protocol  
Oral informed consent was obtained from the eligible women at the initial interviews on the 
phone. The women who agreed to participate in the study were assigned to the groups according 
to the research randomizer software. The women assigned to experimental and control groups 
were planned first home visit and obtained written informed consent was obtained at this visits.  
At the Intervention group; the researcher made pretest (baseline measurements) before the 
nursing intervensions at the first home visit. The researcher offered education and guide about 
prevention of lymphedema after the baseline measurements at the first home visit. Second 
and third home visits were made three and six months after the first visit. At the second 
and the third home visits, the measurements were repeated, and the nursing interventions were 
maintained in the direction of the patients’ individual needs. 
At the control group; the researcher administered the pretests at first home visit. The 
measurements were repeated in the third and sixth months after the first home visit. The 

reseacher also given at the end of the sixth month, all of the nursing interventions, given to the 
intervention group, for the control group. 
Intervention 
Education Material;Breast Cancer Related Lymphedema Education Guide, prepared in light of 
the literature and revised in accordance with three experts opinions, was used at home visits. 
The content of the guide was directed towards supporting seriousness and sensitivity of the 
participants about lymphedema and created by taking account of HBM.  
Home Visits;At the first home visits to the intervention group, the researcher met 
the participants and their families, explained the aim of the study and administered the 
pretests. The guide was introduced, and health education was given. Arm exercises used to 
prevent lymphedema were demonstrated and measurement of the arm circumference was 
taught. Follow-up forms were introduced and from the women were asked to do exercises 
as daily, make measurements as weekly, and record them in the forms day to day regularly. 
The arm measurements made by the researcher were included into the analysis. The 
participants and their families were encouraged to phone and receive counseling about 
things which they needed. Each home visit lasted 45 minutes on average. Three and six 
months after the first visit, the patients were phoned and made an appointment. At the 
second and the third home visits, the measurements were repeated, and the nursing 
interventions were maintained in the direction of the patients’ individual needs (repeate 
of education, exercises and arm circumference measurement, control of follow-up forms).  
At the first home visits in the control group, the researcher was introduced herself, 
explained the study and administered the pretests. The measurements were repeated in the third 
and sixth months after the first home visit. The womens in the control group were not told about 
the nursing interventions, given to the intervention group, during the study period in order to 

avoid bias. At the end of the sixth month, education and guide about prevention of lymphedema 
were offered to this group.  
Reminders; In the intervention group was sent a message reminding behavior 
preventing lymphedema every week. 
Sample size calculation  
Before initiation of the study, to achieve 80% power, 95% confidence interval and 0.05 error 
range, a power analysis was made with G-power software and the sample size was found to be 
14 were in each groups. However, a higher number of participants was planned to be included 
into the study:37 formed the intervention group, 35 formed the control group. At the end of the 
study, a post-hoc power analysis was made by using primary outcome variables. The post-hoc 
power analysis score was .98 for Q-DASH, .94 for SUPPH, .67 for the function scale (FS) and 
.80 for the symptom scale (SS) in EORTC QLQ-BR23. 
Study budget 
The study was supported by The Scientific and Technological Research Council of Turkey 
1002-Short Term Funding Program (number:215S656). 
Hypotheses of the study 
1. Extremity function restrictions will be lower in the intervention group than in the control 
group. 
2. Self-efficacy levels will be higher in the intervention group than in the control group. 
3. Functions improving the quality of life will be higher in the intervention group than in the 
control group. 
4. There will be fewer symptoms reducing the quality of life in the intervention group than in 
the control group. 
5. The incidence of lymphedema will be lower in the intervention group than in the control 
group. 

6. The mean cost of the intervention group at home visits, will be lower than in the control 
group. 
Statistical analysis plan 
Data obtained in this study were analyzed with SPSS 21.0. Multifactorial variance analysis of 
repeated measures was used to compare the groups in terms of dependent variables, the 
significance test of difference between two means to compare pretest and posttest measures, 
one-way variance analysis of repeated measures to compare intragroup pretest and posttest 
measures and t-test for dependent groups with Bonferroni correction to perform further analysis 
of the difference between the mean scores of the groups. Intention-to-treat (ITT) analysis was 
utilized to eliminate effects of dropouts from the study, to maintain randomization. To prevent 
bias the database were analyzed by a statistician who was independent of the study. 
Costs of treatments likely to be given for lymphedema in the intervention group and the 
control group due to the potential incidence of this condition and HBM based nursing 
interventions to be offered at home visits were made. The costs of the nursing interventions 
included time spent by the researcher at home visits, transportation for these visits, reminders 
on the phone, education material and tape measure. The cost of treatment for lymphedema 
included costs of medical treatment of an individual with stage I/II lymphedema in upper 
extremities in hospital. It was based on opinions of three experts. To calculate the costs from 
the perspective of Social Security Institution, prices of services and materials reported in Health 
Services Bulletin issued in Mar 2017 were taken. The expenses directly made by the patients 
were determined by the mean value of prices obtained from three national firms. 
Ethical aspects 
Ethical approval was obtained from DEU Noninterventional Clinical Research Committee 
(Protocol number: 2014/08-19; approval number: 248; date: 4 April 2013 970-GOA) and State 
Hospitals Directorate. Oral informed consent was obtained from the women at the initial 

interviews on the phone and written informed consent was obtained at the first home visits. At 
the end of the study, nursing interventions about prevention of lymphedema were offered to the 
control group. 
In the current study, the HBM based nursing interventions offered at home visits 
decreased perceived barriers to lymphedema management, increased perceived benefits and 
improved self-efficacy in positive health behavior. 
The cost of treatment for lymphedema in the intervention group was four times as low as 
that in the control group, which confirmed the sixth hypothesis. The finding indicated that 
follow-up of women having breast surgery through home visits is a cost-effective 
practice.  Programs conducted in cooperation with public health nurses improve patient care 
outcomes and reduce costs for lymphedema. Sixty-seven percent of the women mention the 
presence of a financial burden of breast cancer treatment and 80% of the women point out to 
the cost of treatment for lymphedema. Treatment of breast cancer costs $14.887-23.167 in 
patients developing lymphedema after breast surgery than those without lymphedema and this 
complication increases indirect costs due to loss of work force. 

Randomization (n=531)
Assessed for eligibility (n=1455)
Allocated to intervention group:100
Allocated to control group (n=100)
Received to intervention group (n=37)
Received to control group (n=35)
Pretest (n=37)
Posttest 1 (n=35)
(3rd month)
Pretest (n=35)
Posttest 1 (n=35)
(3rd month)
Posttest 2 (n=34)
(6th month)
Analysed (n=35)
Excluded from analysis (n=0)
Excluded/Non-inclusion criteria (n=924):
Having primary breast cancer
Having stage I, II and II breast cancer
Having axillary dissection
Receiving radiotherapy
Age over 18 years
The gender female
Residing in the city Samsun
Excluded:
Incorrect address (n=45)
Having lymphedema (n=8)
Refused follow up (n=12)
Excluded:
Incorrect address (n=48)
Having lymphedema (n=7)
Refused follow up (n=8)
Lost to follow-up:
Refused follow up (n=1)
Recurrence (n=1)
Enrolment
Allocation
Follow-Up
Analysis
Measurements
Sociodemographic characteristics 
questionnaire 
EORTC QLQ-BR23 
Q-DASH
SUPPH
Arm circumference measurement 
Reminding sms  
every week
Measurements
EORTC QLQ-BR23 
Q-DASH
SUPPH
Arm circumference measurement 
Measurements
EORTC QLQ-BR23 
Q-DASH
SUPPH
Arm circumference measurement 
Reminding sms  
every week
Lost to follow-up:
Dead (n=1)
Posttest 2 (n=35)
(6th month)
Analysed (n=37)
Excluded from analysis (n=0)
 
Abbreviations: EORTC QLQ-BR23, European Organization for Research and Treatment of 
Cancer Quality of Life Scale for Breast Cancer 23; SUPPH, Strategies Used by Patients to 
Promote Health; Q-DASH, Quick-Disabilities of the Arm, Shoulder and Hand Score. 
FIGURE Consort flowchart