درمان رفتاری شناختی مبتنی بر اینترنت برای اختلالات جنسی در زنان مبتلا به سرطان سینه: طراحی یک کارآزمایی بالینی تصادفی کنترل شده Internet-based cognitive behavioral therapy for sexual dysfunctions in women treated for breast cancer: design of a multicenter, randomized controlled trial

Breast cancer is the most common type of cancer among women in the Netherlands [1]. Improved breast cancer screening and treatment have resulted in increased survival rates [2]. Consequently, more interest and research has focused on the health-related quality of life (HRQL) of breast cancer survivors, including issues of sexuality and intimacy. The prevalence rates for sexual dysfunctions as a result of breast cancer treatment vary between 30% and 100% [3-7]. Breast cancer survivors (BCS) experience worse sexual functioning compared to women without a history of cancer [8-10]. Frequently reported problems include decreased sexual desire (23-64%), decreased sexual arousal or vaginal lubrication (20-48%), anorgasmia (16-36%) and dyspareunia (35-38%) [3]. The different components of breast cancer treatment can all directly or indirectly affect sexual functioning [3]. Previous studies have shown that women who have received chemotherapy are at a higher risk of developing sexual dysfunctions than women who have not undergone this treatment [8,11-17], regardless of the type of surgery [14,18]. Chemotherapy can cause premature, abrupt menopause, leading to reduced sexual desire in some women [19]. It can also induce vaginal dryness and atrophy, which subsequently can affect sexual functioning [6,8,12,13,15,20]. Results with regard to endocrine treatment are somewhat mixed, but studies show that tamoxifen and aromatase inhibitors can lead to sexual problems [21-27]. The evidence pertaining to the effect of surgery on sexual functioning is mixed [28-30], with some studies showing that women who undergo a mastectomy report more problems in sexual functioning than women who receive breast conserving therapy [28,31,32], while other studies have not found an association between type of surgery and sexual functioning [18,29]. More consistent is the finding that mastectomy more often results in compromised body image than does breast conserving treatment [4,13,28]. Other common complaints after breast cancer treatment are concerns about sexual attractiveness and femininity, fatigue, anxiety and depression, fear of loss of fertility, and overall decreased HRQL [3,18,33,34]. Emotional well-being and the quality of the partner-relationship can also be affected by the distress surrounding diagnosis and treatment [35-37]. Although the diagnosis and treatment of any type of cancer can cause problems in sexual functioning [3], breast cancer raises particular concerns because of the importance of the breast in feminine sexuality and the breast as a source of erotic pleasure and stimulation [33]. Sexual dysfunctions can be treated effectively with faceto-face forms of sex therapy [38-41]. Sex therapy typically comprises a flexible treatment program including a number of elements that can be tailored to the needs of individuals and couples. It typically involves behavioral components derived from the sex therapy developed by Masters and Johnson [42], i.e. psycho-education about sexuality and sexual dysfunction, a temporary ban on intercourse, and sensate focus exercises. A ban on intercourse can break the vicious cycle of fear of sexual intercourse and subsequent negative experience and disappointment, and offers the opportunity for positive experiences by eliminating or reducing performance demand [43]. Sensate focus exercises form a hierarchically structured exercise program, through which partners gradually reintroduce the consecutive phases of sexual contact. The exercises are targeted at becoming more comfortable with one’s own body and achieving sexual intimacy with one’s partner, both physically and emotionally. Other goals are to discover new approaches to sexual stimulation, and to encourage communication between partners about sexual experiences, sexual desires and sexual boundaries. These behavioral elements of sex therapy are usually combined with cognitive therapy [40,43]. Through cognitive therapy, therapist and client aim to detect and modify the client’s dysfunctional, disturbing cognitions regarding sexuality that arise during exercises. Via the method of cognitive restructuring, the dysfunctional cognitions are replaced by more functional appraisals. Sex therapy is often delivered in a couple format, but individual applications and group therapy formats are also described in the literature [44,45]. The efficacy of different types of face-to-face therapy for female sexual dysfunction (FSD) has been demonstrated, including sexual desire and sexual arousal disorder [40,46,47], orgasmic disorder [48,49], sexual pain [50,51], and vaginismus [52,53]. Several modified treatment programs have been developed and evaluated for breast cancer survivors [44,54]. Interventions with stronger effects tend to be couple-focused and include treatment components that educate both partners about the woman’s diagnosis and treatment, promote couples’ mutual coping and support processes, and include treatment components that make use of specific sex therapy techniques addressing sexual and body image concerns [44,54]. Despite the availability of effective treatments for sexual dysfunctions, there is a significant discrepancy between the self-reported need for professional sexual health care in cancer survivors and the actual uptake of care [5,55]. Kedde et al. [5] reported that only 40% of BCS who felt a need for care actually consulted a health professional. Hill et al. [55] reported that, although over 40% of gynaecologic cancer and breast cancer survivors expressed interest in receiving professional care, only 7% had ever actually sought such care. Although sexual functioning is an important issue, health care professionals may be reluctant to query breast cancer patients about sexual problems during medical consultations, due to time constraints, embarrassment, lack of knowledge and experience in this area, and/or lack of resources to provide support if needed [56,57]. It may also be difficult for patients to initiate discussion about their sexual difficulties with their health care professional [58-60]. It has been suggested that when reporting sensitive or potentially stigmatizing information, individuals may feel more comfortable undergoing assessment and treatment via the internet [61,62]. This idea is supported by a survey [de Blok G. Thesis on the outpatient clinic for sexuality and breast cancer of The Netherlands Cancer Institute. Unpublished manuscript] that was conducted in women who attended an informational meeting of a sexuality and breast cancer clinic, but who subsequently did not follow-up for an appointment for face-to-face counselling. While some women indicated that they did not consider treatment of their sexual problems to be necessary, others indicated that they did not wish to undergo such treatment in a hospital-setting, or that the face-to-face setting of the counselling formed too great a barrier. Many respondents suggested that internet-based therapy would be a less threatening and more acceptable approach. The advantages of internet-based therapy include privacy, convenience and accessibility [63-65], all of which may be particularly attractive in the area of sexual problems. There is growing evidence that internet-based CBT is an effective method to treat a range of psychosocial problems [66-73]. More recently, internet-based CBT programs for sexual dysfunctions have been developed and tested [45,65,74-77]. However, most of these online interventions have focused on male sexual dysfunctions [74,75,77-80]. Early trials have demonstrated the applicability and effectiveness of online CBT for FSD in the general population [76], and of an online intervention for sexual problems in breast cancer survivors [81]. However, the efficacy of an internet-based CBT for sexual problems in BCS has not yet been researched. In this article, we describe the design of a randomized, controlled, multicenter trial that evaluates the efficacy of an internet-based CBT program for sexual dysfunctions in women who have been treated for breast cancer. We hypothesize that women in the internet-based CBT group will report a significantly greater improvement in sexual functioning and intimacy than women in a waiting-list control group. Secondarily, we hypothesize that women who undergo the internet-based CBT will report significantly less psychological distress and fewer menopausal symptoms, and a significantly greater improvement in body image, marital functioning and HRQL than women in the control group.