Study Protocol and Target Sample
This clinical trial was performed as an experimental study with a pretest-posttest design on two intervention groups and one control group. We aimed to compare the impact of electronic learning and blended learning on the empowerment of the caregivers of cancer patients under chemotherapy who referred to the specialized clinic of Shiraz University of Medical Sciences. The study setting was Shahid Motahari chemotherapy center, Shiraz University of Medical Sciences, Shiraz, Iran. This center provides service everyday on both morning and afternoon shifts. The inclusion criteria entailed age of over 18 years, Iranian nationality, the ability for reading and writing in Persian, not having attended similar classes, and not being affected by psychological disorders. The exclusion criteria were incomplete questionnaires, unwillingness for continuing cooperation, and being absent in more than one session.
In order to determine the final sample size, a pilot study was carried out first. The pilot study was performed on 60 caregivers of cancer patients and the final sample size was calculated as 123 individuals. The participants were randomly allocated to the intervention and control groups by drawing for each group. All the caregivers who met the inclusion criteria were enrolled in the study following the signing of informed consent. The data were collected by a questionnaire, the validity of which was determined by content validity and face validity. The questionnaire was delivered to ten specialized members of the university scientific committee.
They presented their ideas regarding the agreement of questions with aims, as well as the impact coefficient, relevancy, clarity, fluency, and necessity of questions. The comments were evaluated and all items had impact coefficients over 1.5 and suitable face validity. Content validity ratio and content validity index after the omission of unnecessary questions were obtained as 1 and 0.8, respectively. The reliability of the questionnaire was confirmed by the Cronbach’s alpha of 8.7 and the significance level of 0.05.
The questionnaire consisted of two parts, the first of which addressed demographic characteristics, including the age of caregiver and patient, gender of caregiver and patient, caregiver income, education level of caregiver and patient, the number of the children of caregiver and patient, occupation of caregiver and patient, and disease length. The second part was the survey of caregivers’ empowerment and entailed 30 items. This part of the questionnaire had three sections and evaluated the knowledge, attitude, and performance of caregivers. Questions 1–19, 20–25, and 26–30 were related to the knowledge, attitude, and performance of caregivers, respectively. The knowledge section consisted of two-option questions, which had only one correct answer. In case the caregiver had chosen the correct answer they were given a score of 1, otherwise 0.
The attitude and performance questions were scored based on a five-point Likert scale. The total score of the questionnaire was 74 with a knowledge score in the range of 0–19. Scores 0–6, 7–13, and 14–19 were considered weak, moderate, and good, respectively. Attitude score had a range of 0–30 with scores 0–10, 11–20, and 21–30 representing weak, moderate, and good status, respectively. Moreover, the performance score was 0–25 with 0–8, 9–16, and 17–25 showing weak, moderate, and food conditions, respectively.
Intervention group 1 (IG1) received blended training as face-to-face and educational CD. Intervention group 2 (IG2) received the content only as a CD. Three 90-min educational sessions were held by the researcher during three weeks for IG1. The sessions were repeated in small groups for the caregivers who could not attend the training sessions for any reason. In the first session, a pretest was performed and subjects related to cancer, and its statistics, reasons, prevention measures, screening tests, as well as the importance of the role of family caregivers were presented. In the second session, the subjects of the first session were reviewed and chemotherapy definition, some common side effects of chemotherapy, including nausea, vomit, hair loss, anorexia, xerostomia, and facing approaches for these problems were discussed.
In the third session, the first and second sessions were reviewed. Afterwards, common side effects of chemotherapy, including fatigue, hemorrhage, overweight, different infections, nutritional points related to cancer patients under chemotherapy, and the relationship between chemotherapy and diabetes were discussed. Posttest was performed immediately after this session and one month later. It should be noted that caregivers in the control group received the routine care of the ward and a CD of the educational content was given to them after the termination of the study and data collection.