Design
This was a randomized controlled trial with an experimental and a control group, using the pretest, posttest, and follow-up design.
Patient population and sampling
The sample included all women with BC visiting the hematology wards of hospitals and clinics in Bushehr, Iran, in 2023–2024. With the mean and standard deviation of sexual function in the experimental group (M = 49.21, SD = 7.6) and control group (M = 10.14, SD = 1.8) based on Fatehi et al, (34) the alpha Type I error (α = 0.05), and 90% power, a sample size of 42 was obtained. After considering a 20% dropout rate, a sample size of 50 (25 for each group) was determined. Purposive sampling was then performed, and 50 women with BC volunteered to participate in the study. The participants were randomly assigned to the experimental and control groups by block randomization using 5 blocks (25 participants per group).
Inclusion and exclusion criteria
The inclusion criteria were consent and willingness to participate in the study, having BC for the first time, undergoing breast surgery or at least lobectomy, being married, being of reproductive age, no use of drugs affecting sexual activity and antidepressants, having the physical ability to attend the meetings, at least three months having passed since the last chemotherapy/radiotherapy, having at least one domain of sexual dysfunction (score below 3.9), and not having attended any formal education about sexual issues over the past six months. The exclusion criteria were pregnancy or initiation of psychiatric pharmacotherapy at the time of our intervention, recurrence of disease, and disorders interfering with sexual functioning (psychological problems, Alzheimer's, mental retardation, and multiple sclerosis).
Measures
Data gathering tools consisted of a demographic questionnaire and the female sexual function index (FSFI) (35). The FSFI included 19 items evaluating six domains of female sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain during intercourse) over 4 weeks. Sexual desire was assessed with two items. Arousal and lubrication were assessed with four items. Orgasm, satisfaction, and pain were assessed with three items. Response ranges were 1–5 for items 1, 2, 15, 16, and 0–5 for other items. The score for a domain with two, three, and four questions was 0.6, 0.4, and 0.3, respectively. The translations and cultural adaptation of this tool were previously done, and its validity was examined using the experts' opinion. Also, its reliability was confirmed by a Cronbach's alpha coefficient of 0.85 (36).
Data collection
The intervention was administered from 2023 to 2024. Eligible patients were asked to participate in the study and received information about the trial and voluntary participation. They had the right to discontinue participation or withdraw their consent at any time. Patients who wanted to participate signed a written informed consent form before the start of the study. The patients willing to participate in the study filled out the demographic information form and the Female Sexual Function Index (FSFI) questionnaire. Then, the patients with dysfunction in at least one domain of sexual function (score below 3.9), who had other inclusion criteria, were included in the study and assigned to the experimental and control groups by block randomization. The intervention group received 2 group training sessions for 90–120 minutes. Then, patients were divided into groups of 3–4 people, and each group received 3 counseling sessions for 2 hours (one session per week) during one month. Finally, weekly follow-up was done by phone in the intervention group for one month. The content of the educational and counseling sessions was designed based on the four main aspects of self-efficacy theory, which include individual successful experiences, vicarious experiences (observing or expressing experiences of successful models), verbal persuasion, and attention to patients' physiological and emotional reactions (37). The contents presented in the training and counseling sessions are listed in Table 1. The Intervention method included group education, group counseling, group discussions, question and answer sessions, participatory learning techniques, and sharing positive experiences. The educational media used included photographs, videos, and PowerPoint presentations. No intervention was provided to the control group. To respect ethical considerations, at the end of the study, the educational booklet, collected based on reliable references, was given to the control group. The FSFI questionnaire was filled out by both groups before the intervention, immediately after the intervention, and at the follow-up (one month after the intervention).
Table 1
Educational and Consulting intervention based on Self-efficacy theory
Sessions | Content/Techniques to increase self-efficacy |
First | - Offering insights into the advantages of enhancing sexual performance (Raising awareness and motivating the audience by recalling positive past experiences to boost self-confidence and encourage behavior) - Acquiring knowledge about Anatomy and function of the male and female reproductive systems, understanding how sexual organs influence the development of satisfying sexual relationships, and comprehension of the sexual cycle (Breaking down behavior into simple components) |
Second | - Describing common sexual disorders in both men and women. - Providing solutions for sexual dysfunction and creating a satisfying relationship (helping alleviate concerns, anxiety, and depression related to sexual performance issues, paying attention to physiological responses) - Offering interviews or the presence of successful patients in this field to build self-confidence (providing role models or surrogate experiences) |
Third to fifth | - Familiarizing oneself with effective interpersonal skills in creating a sexual relationship - Providing solutions for sexual dysfunction (helping alleviate concerns, anxiety, and depression related to sexual performance issues, paying attention to physiological responses) - Identifying personal barriers (false beliefs) and paying attention to physiological responses (anxiety and depression) - Offering strategies to overcome obstacles in sexual relationship disorders after surgery and expressing the experiences of successful individuals (providing role models or surrogate experiences) - Providing positive feedback and verbal encouragement in response to patients' efforts to change false beliefs |
Data analysis
At the outset of the study, the intention-to-treat analysis was taken into account. Out of 50 participants, two cases from the control group and three cases from the experimental group refused to continue the study, and the analysis was performed on 45 individuals (22 in the intervention and 23 in the control group) (Fig. 1). All the participants remained in their respective groups. All the participants in the experimental groups (n = 22) participated in all the sessions. Therefore, the intention-to-treat analysis was similar to the per-protocol. The data were analyzed in SPSS 20. To evaluate the normality of the distribution of the variables, the Shapiro-Wilk test was carried out. All variables showed a normal distribution in both groups and at all three evaluation times. In line with the research objectives, descriptive statistical indices (mean, standard deviation, percentage, frequency) and analytical tests including the Independent T-test, Mann-Whitney U, Chi-square, and Fisher's exact test were used to compare demographic variables. Additionally, repeated-measures analysis of variance (ANOVA), Least Significant Difference (LSD) test, and Mann-Whitney U were performed for within- and between-groups comparisons. The significance level was set at < 0.05.