2.1 Study design
This research study is conducted as a randomized clinical trial examining the efficacy of a designed family-need-based program on relieving depression, anxiety, and stress of family caregivers of leukemia patients by meeting the specific psychological needs of caregivers. The program involved three steps, comprising a preliminary phase of needs assessment, a step of education containing five training sessions, and a follow-up period. All steps were made respectively. The researchers carried out the research program through pretest and posttest in control and study groups in three stages.
2.2 Study population and Sample size calculation
The study population consisted of family caregivers of leukemia patients, involving ALL, AML, male, and female referring to Seyed Al Shohada University Hospital, Isfahan, Iran. A random sample was drawn according to inclusion criteria [16]. The sample size was calculated considering the objective of comparing two independent groups. The calculation was made considering the methodology of a sample calculation for a Pearson's Chi-square test. In this estimate, a 5% significance level, an 80% test power, a 0.30o of freedom, and effect size were assumed, which can be considered a medium degree effect size [17]. The sample size obtained was 70 family caregivers of leukemia patients (35 per group). The software SPSS 20 was used.
2.3 Recruitment and Randomization
According to the inclusion criteria, people who referred to Sayed Al-Shohada Medical Center in Isfahan, Iran, who were the primary caregiver of a patient diagnosed with leukemia (ALL and AML) that means the family member who took the major responsibility of care for a leukemia patient and committed the largest proportion of time in the care for the patient, who were over 18 years old, who were able to communicate and comply with the rules of training sessions, who were just caring for one patient with leukemia refractory in the family, who were interested in participating in the study, who were able to speak, read, or write in Farsi, and who were not participating in other similar studies were chosen to join the study program. If the family caregiver did not attend more than two training sessions, had any issue that prevented them from taking care of the leukemia patient, or if the patient passed away, those caregivers were excluded from the study. Inclusion criteria related to patients were to be 18 or older, be in stage 0 of leukemia (ALL and AML), or higher, be diagnosed with leukemia over a month ago.
All of the family caregivers of leukemia patients admitted to the participating hospital during the survey period were invited to participate in this study. The personal data questionnaires were completed through face-to-face interviews in a private office in the hospital. The interviewers were four dedicated investigators recruited from research students in Isfahan University of Medical Sciences and trained before embarking on the survey. The interviewers identified 85 eligible family caregivers. Of these eligible family caregivers, 15 individuals expressed no interest and declined to participate. The participating family caregivers were encouraged to self-complete the questionnaires. But assistance from the interviewers was always available if necessary. For instance, if the respondent had a low visual acuity or another disability. The interviewers reviewed the returned questionnaires and asked the respondents to complete missing items if any. 70 questionnaires were included in randomization.
By the drawing method and using the table of random numbers, our research assistant who was responsible for conducting the education program divided the family caregivers into study and control groups, while the research team was blinded to randomization. Equally, 35 people were in the study and 35 people in the control group.
2.4 Questionnaires
In addition to questionnaires concerning personal data, embracing characteristics of the leukemia patients and their primary family caregivers, in this study, the Farsi version of the scale of depression, anxiety, and stress (DASS-42) was completed.
2.4.1 The personal data questionnaire
The personal data questionnaire included individual features of the patients and their family caregivers separately. The demographic information of the family caregiver was including sex, age, marital status, education level, employment, relation to the patient, and the duration of caring for the leukemia patient. The patients' features were including age, sex, marital status, education level, employment, and duration of being diagnosed with leukemia.
2.4.2 The scale of depression, anxiety, and stress (DASS-42)
DASS-42 is a self-report questionnaire that measures depression, anxiety, and stress [18]. It was designed in 1997 and has been used repeatedly in different research programs [19]. DASS-42 is comprised of 42 items. Each item has three 14-item subscales scoring on the four-point Likert scale, ranging from zero (did not apply to me at all) to three (applied to me very much, or most of the time) [20]. Each subscale ranges from zero to 42. Summing the items on each subscale calculates the overall score accordingly [21]. Scores above 20, 14, and 25 on the depression, anxiety, and stress subscales respectively are indicative of severe levels [22]. The Farsi version of DASS-42 has shown great scientific integrity and validity as well as consistency and reliability [23]. According to related studies, Cronbach's Alpha for depression, anxiety, and stress were 0.94, 0.85, and 0.87, respectively for the Farsi version of the questionnaire [24]. Test-retest reliability coefficients, besides, were 0.80, 0.89, and 0.77 for depression, anxiety, and stress in the given order [25].
2.5 Setting
The researchers included one preliminary needs assessment step, one step of education comprising five training sessions, and one follow-up period in the study program. To do so, our responsible research assistant for setting up the educational intervention for family caregivers of leukemia patients, firstly, introduced herself to the participants. She fully explained the purpose of the study and the duration of the intervention and answered relevant questions. On the condition that the family caregiver was willing to participate in the program, they signed consent forms before the beginning of the intervention, then the program continued. Each step of the study program is discussed as follows:
2.5.1 The first step: The preliminary phase of needs assessment
The study program was started with a preliminary phase that was the needs assessment, which consisted of group discussions, interpretation, and compilation of all comments. This step started with field studies and then the investigators set up group discussions with the family caregivers of both study and control groups, patients of both groups, and specialists. To do so, ten 60-minute discussion sessions were held on 10 days. Each discussion session was held by 10 to 15 participants, including family caregivers, patients, specialists, and researchers. Participants were invited to attend any free discussion panel in accordance with their wishes. All participants attended the classes at least one time. The topic of all discussions was concentrated on overriding priorities and concerns of family caregivers about leukemia and patients [26]. Even though family caregivers were the central focus of this study program, in addition to family caregivers, health care professionals, and patients were interviewed to their expectations of family caregiving be assessed. The researchers tape-recorded and transcribed statements and then extracted key statements. The key terms were coded, and primary codes were grouped into the concepts. Measuring discrepancy between the current condition and wanted condition appropriately identified the family caregivers’ paramount needs; based on the extracted concepts, the topic for each training session was outlined [27–30]. The specific requirements that were identified in this population of family caregivers during the preliminary phase of needs assessment and then addressed in the subsequent step are according to Table 1.
TABLE 1 The specific content of each training session of the family-need-based program for this population of family caregivers of leukemia patients based on the detailed needs assessment step
Session
|
Assessed need
|
Title
|
First session
|
Lack of information on
|
Objective: discuss the framework and rules of this group.
This session included these items: introducing family caregivers and researchers to each other, setting plans and goals according to specific needs outlined in step one (needs assessment), completing DASS-42 for both study and control groups, answering related questions about leukemia and the specific needs of leukemia patients and family caregivers.
|
. the specific needs of family caregivers and leukemia patients
|
Second session
|
. Standard treatments for leukemia
. Potential complications during and after therapies
|
Objective: describe potential weaknesses and strengths.
This session included: Over the previous session, exchanging information on different standard treatments for leukemia, potential complications after therapies, and the importance of follow-up, being in contact with the medical team, and considering the role of family caregivers in taking care of leukemia patients.
|
Third session
|
. ways of self-care management
|
Objective: describe potential capabilities.
This session included: reviewing the two previous sessions’ content, providing information about the importance of self-care management for family caregivers and leukemia patients, and possible ways of interaction between family and professional caregivers.
|
Fourth session
|
. Problem-solving skills
. Techniques of relieving psychological distress
|
Objective: describe the ways to recognize and enhance ability.
This session included: reviewing the three previous sessions, acquiring information on problem-solving skills and techniques of relieving psychological distress, including teaching relaxation techniques for managing stress and anxiety at home. Explaining the importance of recognizing and reporting symptoms of depression such as hopeless outlook, lost interest, increased fatigue, sleep problems, irritability, changes in appetite and weight, uncontrollable emotions, and looking at death, and also ways of managing them such as calling a local emergency number, avoiding social isolation, removing anything that may cause harm, and listening but not judging.38
|
Fifth session
|
. Identifying misconceptions about leukemia patients, and their effects on emotional modes
|
Objective: Change the attention.
This session included these items: over the previous sessions, the interaction between family caregivers and researchers, identifying misconceptions about leukemia patients, and their effects on emotional modes, teaching the reassessment strategies. The participant family caregivers of leukemia patients could listen to a guest preacher for spiritual fulfillment. CDs and booklets on the concise overview of the course outline were presented to the study group participants. Immediately after the fifth session, the DASS-42 was completed for both study and control groups for the second time.
|
2.5.2 The second step: The training sessions
The specific needs that were identified in the preliminary phase of the needs-assessment were summarized and fell into the specific-need categories. Objectives were entitled and the training-health-care program was outlined for the study group. five 90-minute sessions during a month with eight to12 family members who took the primary responsibility for taking care of leukemia patients were held. Each training session was held on a separate day. We offered the same session over 5 days of the week and the next week we started the new next session and repeated the new session for 5 days and so forth (25 sessions in all). In this way, the timing of attending each session was in the order of personal preference of the family caregivers and they had the opportunity to choose the day when they would participate in the same session. Our research assistant used slide shows, images, pamphlets, and speeches in classes. Methods of questions and answers, role-playing, and lectures were adopted, and techniques of problem-solving, such as brainstorming, group discussion, and organizing small groups for sharing information were tried. The specific content of each training session of the family-need-based program is in Table 1.
2.5.3 The third step: The follow-up period
Within one month after the last session of the face-to-face training sessions, the family caregivers of leukemia patients of the study group were given advice based on their needs via telephone calls, and if needed, they were referred to the assistance unit or psychiatrist specialists. The average and range for the number of calls, duration of calls, and content of calls were on the family's needs and wishes as researchers were available.
The control group was supported by routine care plans and did not participate in the training sessions nor follow-up period.
2.6 Data collection
Data were collected in three stages, including before the first training session (before the second step), after the fifth training session (after the second step), and after the one-month follow-up (after the third step) by using personal data questionnaires and the DASS-42 questionnaire.
2.7 Statistical methods
To describe research results and analyzing and comparing baseline differences of personal data of participants, information summary methods in descriptive (frequency table, mean, mode, standard deviation, and calculating the percentage) and inferential statistics were used. To investigate the studied variables of the normal distribution, the Kolmogorov–Smirnov test was used. To investigate the homogeneity of control and study groups in terms of demographic characteristics, the independent statistical Chi-square test, Mann–Whitney test, and t-test were used.
As it was intended, the levels of depression, anxiety, and stress of family caregivers of leukemia patients were measured in three stages and compared two by two. Therefore, researchers used the paired t-test to determine if there is a significant difference between the means of the two independent groups. The repeated measures analysis of variance (ANOVA) also was used to compare the changes between groups. To compare the mean difference of depression, anxiety, and stress scores in control and study groups before and after the intervention, an independent t-test statistical method and paired t-test were used. To evaluate the relationship between individual features of participants and scores of DASS-42, one-way variance tests, independent and paired t-test were used. In all statistical tests, the level of significance was 0.05. To calculate and analyze statistical information, version 20 of SPSS (Chicago, IL, USA) software was applied.