A Randomized Study of an Internet-based Cognitive Behavioral Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer.

Background. Breast cancer is the most common cancer among women in the Netherlands, with an incidence of 71 per 100.000 person-years, and a lifetime risk of 10%. Currently, 85% of women with breast cancer live longer than 5 years, and 75% 10 years or longer(1,2). As a result, more interest and research has focused on the health-related quality of life (HRQL) of breast cancer survivors, including issues of sexuality and intimacy. Compelling evidence has established that sexual dysfunction is a prevalent, long term complication of breast cancer and its treatment (3,4-11). Overall, approximately 50% of breast cancer survivors report some form of sexual dysfunction as a result of treatment(6,10,13-15). Frequently reported problems regarding intimacy and sexuality include decreased sexual desire (23-64%), decreased arousal or lubrication (20-48%), anorgasmia (16-36%) and dyspareunia (35-38%)(10). Hill et al. report that over 40% of the breast cancer and gynaecological cancer survivors in their study expressed interest in receiving professional sexual health care(15). However, there is a significant discrepancy between the self-reported need for professional sexual health care and the actual uptake of care(16). Hill et al.(15) reported that, although over 40% of their sample expressed interest in receiving professional care, only 7% had ever actually sought such care. Although sexual functioning is an important issue, it may be difficult for women to initiate discussion with their general practitioner or medical specialist. Health care professionals may also be reluctant to query about sexual problems, due to time constraints, embarrassment, and/or lack of experience and communication skills in this area(16,17). Many women consider face-to-face sexual counselling to be confronting, and see internet-based interventions as a less threatening and more acceptable approach(18,19). There is growing evidence that internet-based cognitive behavioural therapy (CBT) can effectively treat a range of psychosocial problems, including anxiety, depression and PTSD(20,21). More recently, internet-based cognitive behavioural therapy programs for sexual dysfunction have been developed, typically paralleling the content of face-to-face therapy, with studies showing the efficacy of these internet-based programs in improving sexual functioning(22-25).

Design. This pragmatic clinical trial will employ a prospective, randomized design with one intervention group and a control group. Potentially eligible patients will be identified through the hospital registries. These patients will be sent a letter signed by their treating/former surgeon, together with an informational brochure about the study and possible cancer-related intimacy and sexuality problems. Women who are potentially interested in participating in the study will be asked to indicate this on the enclosed response card. Women who are not interested in participation will be requested to return the response card to indicate their motive(s) for not being able to participate. Women who are not interested in participation or who do not respond to the invitation to participate in the study will not be contacted again. If interested, women are asked to write down their contact information. Those women who return the questionnaire will be contacted by telephone by one of the members of the study staff to inform them more thoroughly about the study purpose and procedures. At this time, additional questions will be posed regarding current treatment of sexuality/intimacy problems, current participation in a research trial with a focus on alleviating sexuality/intimacy problems, access to internet, date of breast cancer diagnosis, and completion/continuation of the different parts of treatment of breast cancer (chemotherapy, radiation therapy, endocrine treatment).

Those women who remain interested in the study and who appear to be eligible will undergo an intake evaluation by telephone with a sexologist who will carry out a more extensive diagnostic interview in order to determine final eligibility of the woman for the internet-based cognitive behavioral therapy program. Questions will be asked about problems with sexuality and intimacy and relationship/marriage.

If the woman meets final eligibility criteria, she will receive a baseline questionnaire, together with an informed consent form. The questionnaire will assess sociodemographic and medical background variables, and the primary (sexuality and intimacy problems) and secondary study outcomes (body image, menopausal symptoms, marital functioning, psychological distress and health-related quality of life). In total, 160 consenting women will be randomized to either the intervention group (n = 80), or to a control group (n = 80) using the minimization technique, with primary surgery (breast conserving treatment; mastectomy without reconstructive surgery; mastectomy with reconstructive surgery), menopausal status (premenopausal; postmenopausal), current endocrine treatment for breast cancer (yes; no), and time since breast cancer diagnosis (<1 year; 1-3 yrs; 3-5 yrs) as stratification variables. Women allocated to the intervention group will be asked to complete a battery of questionnaires assessing primary and secondary outcomes at four points in time: ten weeks after the start of the CBT program (T1), and at post-treatment (T2; to achieve an equivalent average assessment time for both study groups, women in the intervention group complete T2 post-treatment, but always between 20 and 24 weeks after start of therapy. Women who finish the CBT prior to 20 weeks complete T2 20 weeks after start of therapy). The last two questionnaires are completed 3-months after completion of therapy (T3) and 6 months after T3 (T4). The control group is not asked to complete T3 or T4, but rather is given the opportunity to undergo the intervention following completion of T2. This was done because it was not deemed ethically acceptable to withhold the intervention from women in the control group for the prolonged period of time that would be required if they were to be first asked to complete all follow-up sessions (i.e., approximately one year after study enrollment). To minimize respondent burden, the T4 questionnaire only includes questionnaires assessing the primary outcome measures.

Control group. Women who are assigned to the control group will be contacted by telephone by a member of the study staff to inform them about this allocation. These women will receive a booklet per mail that addresses 80 questions about sexuality and cancer. Six weeks later, women in the control group will receive an empathetic phone call from one of the sexologists, during which there is also time available to discuss further questions the participants may have concerning sexuality and cancer. The purpose of keeping in contact with the control group, as opposed to a pure waiting list control group, is creating the opportunity to provide some control for a possible attention placebo-effect. Ten weeks post study entry, women in the control group will be asked to complete the first follow-up questionnaire. After completion of the questionnaire, women in the control group will be telephoned by a member of the study staff for another empathetic conversation. Women in the control group will complete a final questionnaire twenty weeks post study entry, after which they will be given the opportunity to undergo the internet-based cognitive behavioral program.