This quasi-experimental study was conducted with two intervention and control groups with a pre-test and post-test design on 70 family caregivers of patients with breast cancer who visited the hematology department of Khatam Al Anbia Hospital in Zahedan in 2023. The participants were selected through convenience sampling and then were randomly assigned to two intervention and control groups. To do so, 70 cards were prepared, out of which 35 were labeled as the intervention group and 35 as the control group. The cards were mixed, and each caregiver removed a card by chance and was placed in the group whose name was on the card. Accordingly, all caregivers were randomly placed into the intervention and control groups.
The inclusion criteria for the patients were having breast cancer without metastasis undergoing chemotherapy, being at least 20 years old, and living with the family. The inclusion criteria for the caregivers were being responsible for all the care and support responsibilities of the patient, age older than 20 years old, not attending any training and counseling program at the same time, having the ability to use a smartphone, the presence of only one member in the family who needs care, the absence of severe stress in the last 6 months such as the loss of relatives, having at least a middle school degree, and the absence of known neurological diseases. The exclusion criteria were the failure to perform more than one training activity provided on the site, the occurrence of a traumatic event during the study, assigning the task of caring for the patient to another family member, and the death of the patient.
The sample size was estimated based on the mean caregiver burden score in a similar study (Behzadi et al.), with a 95% confidence interval and 95% test power, and based on the following formula (
18). According to similar studies, taking into account possible dropout and ensuring sampling adequacy, the sample size was considered 35 persons per group (70 persons in total).
The data for this study were collected using a demographic information form, which assessed participants' gender, age, marital status, occupation, education, place of residence, relationship with the patient, and duration of care. Additionally, the Caregiver Burden Inventory (CBI; Novak & Guest, 1989) was used to measure caregiver burden among family caregivers. This instrument consists of 24 items that evaluate caregiver burden across five dimensions: Time-dependence, developmental, physical, social, and emotional burden. Responses are based on a five-point Likert scale ranging from completely untrue (1), untrue (2), undecided (3), true (4), to completely true (5). The total score ranges from 24 to 120, with higher scores indicating a greater caregiver burden and lower scores reflecting a lesser burden. Novak and Guest reported reliability coefficients of 0.85 for time-dependent caregiver burden and Cronbach's alpha values of 0.86, 0.73, and 0.77 for physical, social, and emotional burden, respectively (
19). Abbasi et al. confirmed the inventory's reliability with a Cronbach's alpha of 0.80 for use in Iran, and its validity was determined to be 90% using the content validity method (
20). In this study, the reliability of the CBI was confirmed with a Cronbach's alpha of 0.83.
After obtaining the necessary approvals from the vice-chancellor for research and technology at the university, the researcher visited the hematology department of Khatam al-Anbia Hospital in Zahedan. The researcher first identified patients with breast cancer and then spoke with their main caregivers who met the inclusion criteria, explaining the study's objectives and assuring the confidentiality of their information. Caregivers who provided informed consent were selected through convenience sampling and subsequently assigned to intervention or control groups using simple randomization.
After completing the demographic information form, participants in both groups filled out the CBI as a pre-test. A mobile-based practical website called “positive” was developed by an experienced team, and participants in the intervention group were granted free access. The steps for developing the web-based program included identifying the target group and their needs, setting educational goals, determining technical requirements, developing the website, identifying potential obstacles, selecting and organizing content, structuring the sequence of information, and choosing methods for media and content delivery.
The Positive website offered several features, including the ability to create personal accounts and passwords, interaction with a symbolic character called Positive, access to Decalogue exercises related to mental health based on Lluch-Canut's 10 recommendations (
21), opportunities for caregivers to provide feedback on educational content, daily educational messages about breast cancer, videos prepared by the researcher, and a discussion forum. Each Lluch-Canut recommendation included two activities, resulting in a total of 20 activities. An example of a recommendation and its related activities is shown in
Table 1.
| Recommendation | Activity |
|---|
| Appreciate the good things you have in your life | Activity 1: |
| Step 1: Please answer the following question: "What good things do you have in life?" |
| - My children |
| - My colleagues |
| - My parents |
| - My friends |
| - My spouse |
| - My job |
| - Other things |
| Step 2: Take a moment during the day to enjoy some of the good things you have. |
| • If the activity is not performed, the caregiver will receive a reminder later to end the activity: - “Did you find a moment to enjoy?” |
| • If the answer is no, the message "Remember to enjoy the good things you have" appears. |
| • If the answer is yes, the caregiver is asked "Did you enjoy this activity or not? |
| • If the answer is yes, the message "We're glad you're enjoying the good things you have, enjoy them when you can" appears. |
| • If the answer is no: "Don't worry, most of the time things don't go as you expect." |
| Activity 2: |
| Please look at your photo and answer the following questions: |
| - I am beautiful |
| - I am happy |
| - I'm fine |
| - I am responsible |
| - I am active |
| - I am a caregiver |
| - I am creative |
| - I am flexible |
| - I am kind |
| - I am sober |
| - I am efficient |
| - I am cautious |
| The following statement appears in all the cases that gave a positive answer: "These are the characteristics that you have." |
| The following statement appears in all the cases that gave a negative answer: "We all have positive qualities. Think about your qualities today”. |
| Note; For finishing the activity you will receive the following advice: "Grow positivity by increasing your positive mental health". |
The Positive character, shaped like an onion, visually evolved over four weeks. Caregivers received activities from Saturday to Wednesday. Upon logging into the website, a daily welcome message, “Hello. Good morning,” appeared, followed by a question about the caregiver's emotional state: “How are you feeling today?” At the end of each activity, caregivers were asked, “Was today's activity useful for you?” If a caregiver failed to complete an activity for one day, the subsequent day's activity was locked and inaccessible.
The instructional content of the website included topics such as: What is cancer? What type of cancer is breast cancer? Breast cancer screening methods, Breast cancer diagnostic methods, Breast cancer treatments, Breast cancer treatment complications, Breast self-examination, and breast cancer in men. The intervention lasted for 20 days. Caregivers in the intervention group were instructed on how to use the website. To prevent access by the control group, each participant in the intervention group received a unique login code via SMS.
The control group did not receive any training or intervention during the study. One month after completing the intervention, participants in both groups completed the CBI as a post-test. To adhere to ethical protocols, the website address was shared with control group participants after the intervention concluded.
3.1. Data Analysis
The collected data were analyzed using SPSS-27 software, employing both descriptive and inferential statistical methods. The Shapiro-Wilk test was utilized to assess and confirm the normality of the data related to psychological burden in the pre-intervention and post-intervention phases, as appropriate for the sample size. Descriptive statistics, including mean, standard deviation, frequency, percentage, minimum, and maximum values, were calculated for all variables.
The mean scores within each group were compared using the paired samples t-test, while the mean caregiver burden scores between the two groups were analyzed with the independent samples t-test. Additionally, the chi-square test was employed to compare the frequency distributions of qualitative variables between the intervention and control groups. To evaluate the effectiveness of the intervention while controlling for the pre-test effect, analysis of covariance (ANCOVA) was performed.
A significance level of less than 0.05 (P < 0.05) was considered statistically significant throughout the analyses.