The present quasi-experimental study examined 78 mastectomized women who visited the Cancer Clinic of Omid Hospital in Mashhad from May to January 2021. Inclusion criteria of the study were as follows: informed consent to participate in research, literacy, being married, being at the age of 18-49, passing at least one year after mastectomy, sexual function score of less than 28, non-use of drugs and alcohol in wife and husband, no use of drugs affecting sexual function by the person or her husband, not receiving sexual counseling during the last 6 months, not suffering from psychiatric illnesses, and moderate and severe depression, and lack of experience of accidents in the last 1 month. Exclusion criteria were as follows: absence from a counseling session, recurrence of symptoms of breast cancer or its metastasis or other cancers, and death of the patient. The sample size was obtained 33 per group according to one study conducted by Karimi et al(17). Using the formula of the mean of two independent populations, the minimum sample size, and considering a confidence interval of 95%, and test power of 80%. By considering the 20% probability of loss, the final sample size was 40 per group and a total of 80 individuals. Sampling was performed after obtaining the approval of the University Ethics Committee and submitting a written letter of recommendation from the School of Nursing and Midwifery to the Breast Cancer Clinic of Omid Hospital and obtaining their consent. First, approximately 400 cases of breast cancer patients were studied from 2011 to 2020, and approximately 250 patients with primary conditions were selected. Then, they were contacted, and 80 patients with the inclusion criteria were selected, and written consent was obtained from them after providing the necessary information about the study and its objectives. They completed the questionnaires after receiving information on how to respond to each questionnaire and assuring them that the information would be confidential. After selecting eligible individuals, random allocation of individuals to the two consulting groups, BETTER and PLISSIT, was performed in random blocking using the table of random numbers from the website of www.randomization.com. The created sequences were recorded on small sheets and placed in sealed envelopes. The envelopes were opened according to the order of the arrival of the research units, and the assigned group was revealed. The final study was conducted on 78 individuals due to the loss of 2 units (One in the BETTER group due to death, and another in the PLISSIT group due to absence from counseling sessions).
The research tools included the demographic information form, the female sexual function index (FSFI), and the Hulbert index of sexual assertiveness (HISA), which were completed by the units before the intervention. The demographic information form included 37 questions prepared by studying new and valid references and articles, and its validity was confirmed by 7 faculty members of Mashhad University of Medical Sciences. The FSFI included 19 questions in six fields of sexual desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual intercourse. The reliability of the questionnaire was determined by Mohammadi (2008) using the internal consistency method by calculating the Cronbach's alpha coefficient of 0.7(18), and it was 0.87 in the present study according to Cronbach's alpha. The HISA consisted of 25 questions with a score ranging from 0 to 100. The higher score indicated higher sexual assertiveness, and the lower score exhibited lower sexual assertiveness(19). The reliability of the tool was 0.83 using the Cronbach's alpha coefficient in one study conducted by Azmoude et al.(20), and it was 0.87 by the Cronbach's alpha in the present study.
In the PLISSIT counseling group, four 60-90-minute individual counseling sessions were held one week apart. Permission stage: In a safe and trustworthy environment, the counselor allows the clients to talk about sexual issues and express their concerns and problems. Giving limited information: The counselor provides limited, real, and fact-based information in response to a question or potential sexual problems admitted by the clients. Specific suggestions: At this stage, the counselor offers specific and appropriate suggestions for the patient's sexual problem. The main solution to the problems at this stage is developed by the authorities’ decisions and the counselor’s guidance. Intensive therapy: If the problem persists, the clients are referred to a sex therapist or specialist.
In the BETTER counseling group, four 60-90-minute sessions of individual counseling were held one week apart based on the BETTER model as follows: Bringing up: Discussing the issue of sexual relations with the patient and reassuring the patients for being comfortable in expressing their sexual issues, then evaluating sexual beliefs and activities in the present. Explaining: The counselor explains the importance and impact of sexual issues on quality of life and tells the clients that they are completely free to talk about it. It helps to normalize sexual discourse and reduce the clients' sense of shame. Telling: Informing and explaining the patients' sexual problems using available scientific references. Timing: Paying attention to scheduling and discussing when the person is ready. Since sexual relation is an ongoing process, a counselor is available at any time to address the clients' concerns and answer their questions. Educating: Educating the patients about potential changes in sexual function due to cancer and its treatments, and recognizing and correcting the clients' misconceptions about sex after cancer. Recording: Recording important aspects of discussions, evaluations, and interventions.
Four weeks after the intervention, the HISA was re-completed by the research units.
After collecting and encoding the study data, they were inserted into the computer and analyzed by the Kolmogorov-Smirnov test, paired t-test, independent t-test, and Chi-square in SPSS 16.