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      Internet-based cognitive behavioral therapy for sexual dysfunctions in women treated for breast cancer: design of a multicenter, randomized controlled trial

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          Abstract

          Background

          Sexual dysfunction is a prevalent, long-term complication of breast cancer and its treatment and can be treated effectively with face-to-face sexual counselling. However, relatively few women actually opt for face-to-face sex therapy, with many women indicating that it is too confronting. Internet-based interventions might be a less threatening and more acceptable approach, because of the convenience, accessibility and privacy it provides. Recent studies have demonstrated the efficacy of internet-based programs for improving sexual functioning in the general population. The objective of the current study is to investigate the efficacy of an internet-based cognitive behavioral therapy (CBT) program in alleviating problems with sexuality and intimacy in women who have been treated for breast cancer.

          Methods/design

          In a multicenter, randomized controlled trial we are evaluating the efficacy of an internet-based CBT program in reducing problems with sexuality and intimacy in breast cancer survivors. Secondary outcomes include body image, marital functioning, psychological distress, menopausal symptoms, and health-related quality of life. We will recruit 160 breast cancer survivors (aged 18-65 years) with a formal DSM-IV diagnosis of sexual dysfunction from general and academic hospitals in the Netherlands. Women are randomized to either an intervention or waiting-list control group. Self-report questionnaires are completed by the intervention group at baseline (T0), ten weeks after start of therapy (T1), post-treatment (T2), 3 months post-treatment (T3), and 9 months post-treatment (T4). The control group completes questionnaires at T0, T1 and T2.

          Discussion

          There is a need for accessible and effective interventions for the treatment of sexual dysfunctions in breast cancer survivors. This study will provide evidence about the efficacy of an internet-based approach to delivering a CBT intervention targeted specifically at these sexual health issues. If proven to be effective, internet-based CBT for problems with sexuality and intimacy will be a welcome addition to the care offered to breast cancer survivors. Hopefully this therapy will lower the barrier to seeking help for these problems, resulting in improved quality of life after breast cancer.

          Trial registration

          The study is registered at ClinicalTrials.gov ( NCT02091765).

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          Most cited references79

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          The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction.

          To develop a brief, reliable, self-administered measure of erectile function that is cross-culturally valid and psychometrically sound, with the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. Relevant domains of sexual function across various cultures were identified via a literature search of existing questionnaires and interviews of male patients with erectile dysfunction and of their partners. An initial questionnaire was administered to patients with erectile dysfunction, with results reviewed by an international panel of experts. Following linguistic validation in 10 languages, the final 15-item questionnaire, the international index of Erectile Function (IIEF), was examined for sensitivity, specificity, reliability (internal consistency and test-retest repeatability), and construct (concurrent, convergent, and discriminant) validity. A principal components analysis identified five factors (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) with eigenvalues greater than 1.0. A high degree of internal consistency was observed for each of the five domains and for the total scale (Cronbach's alpha values of 0.73 and higher and 0.91 and higher, respectively) in the populations studied. Test-retest repeatability correlation coefficients for the five domain scores were highly significant. The IIEF demonstrated adequate construct validity, and all five domains showed a high degree of sensitivity and specificity to the effects of treatment. Significant (P values = 0.0001) changes between baseline and post-treatment scores were observed across all five domains in the treatment responder cohort, but not in the treatment nonresponder cohort. The IIEF addresses the relevant domains of male sexual function (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), is psychometrically sound, and has been linguistically validated in 10 languages. This questionnaire is readily self-administered in research or clinical settings. The IIEF demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction.
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            Body image and sexual problems in young women with breast cancer.

            The purpose of this study was to determine the frequency of body image and sexual problems in the first months after treatment among women diagnosed with breast cancer at age 50 or younger. Breast cancer treatment may have severe effects on the bodies of younger women. Surgical treatment may be disfiguring, chemotherapy may cause abrupt menopause, and hormone replacement is not recommended. A multi-ethnic population-based sample of 549 women aged 22-50 who were married or in a stable unmarried relationship were interviewed within seven months of diagnosis with in situ, local, or regional breast cancer. Body image and sexual problems were experienced by a substantial proportion of women in the early months after diagnosis. Half of the 546 women experienced two or more body image problems some of the time (33%), or at least one problem much of the time (17%). Among sexually active women, greater body image problems were associated with mastectomy and possible reconstruction, hair loss from chemotherapy, concern with weight gain or loss, poorer mental health, lower self-esteem, and partner's difficulty understanding one's feelings. Among the 360 sexually active women, half (52%) reported having a little problem in two or more areas of sexual functioning (24%), or a definite or serious problem in at least one area (28%). Greater sexual problems were associated with vaginal dryness, poorer mental health, being married, partner's difficulty understanding one's feelings, and more body image problems, and there were significant ethnic differences in reported severity. Difficulties related to sexuality and sexual functioning were common and occurred soon after surgical and adjuvant treatment. Addressing these problems is essential to improve the quality of life of young women with breast cancer.
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              Efficacy of an Internet-based behavioral intervention for adults with insomnia.

              Insomnia is a major health problem with significant psychological, health, and economic consequences. However, availability of one of the most effective insomnia treatments, cognitive behavioral therapy, is significantly limited. The Internet may be a key conduit for delivering this intervention. To evaluate the efficacy of a structured behavioral Internet intervention for adults with insomnia. Forty-five adults were randomly assigned to an Internet intervention (n = 22) or wait-list control group (n = 23). Forty-four eligible participants (mean [SD] age, 44.86 [11.03] years; 34 women) who had a history of sleep difficulties longer than 10 years on average (mean [SD], 10.59 [8.89] years) were included in the analyses. The Internet intervention is based on well-established face-to-face cognitive behavioral therapy incorporating the primary components of sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. The Insomnia Severity Index and daily sleep diary data were used to determine changes in insomnia severity and the main sleep variables, including wake after sleep onset and sleep efficiency. Intention-to-treat analyses showed that scores on the Insomnia Severity Index significantly improved from 15.73 (95% confidence interval [CI], 14.07 to 17.39) to 6.59 (95% CI, 4.73 to 8.45) for the Internet group but did not change for the control group (16.27 [95% CI, 14.61 to 17.94] to 15.50 [95% CI, 13.64 to 17.36]) (F(1,42) = 29.64; P < .001). The Internet group maintained their gains at the 6-month follow-up. Internet participants also achieved significant decreases in wake after sleep onset (55% [95% CI, 34% to 76%]) and increases in sleep efficiency (16% [95% CI, 9% to 22%]) compared with the nonsignificant control group changes of wake after sleep onset (8% [95% CI, -17% to 33%) and sleep efficiency (3%; 95% CI, -4% to 9%). Participants who received the Internet intervention for insomnia significantly improved their sleep, whereas the control group did not have a significant change. The Internet appears to have considerable potential in delivering a structured behavioral program for insomnia. clinicaltrials.gov Identifier: NCT00328250.
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                Author and article information

                Contributors
                L.hummel@nki.nl
                Jacques.vanLankveld@ou.nl
                h.oldenburg@nki.nl
                d.hahn@nki.nl
                e.broomans@virenze.nl
                n.aaronson@nki.nl
                Journal
                BMC Cancer
                BMC Cancer
                BMC Cancer
                BioMed Central (London )
                1471-2407
                28 April 2015
                28 April 2015
                2015
                : 15
                : 321
                Affiliations
                [ ]Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
                [ ]Faculty of Psychology and Educational Sciences, Open University, Valkenburgerweg 177, 6419 AT, Heerlen, The Netherlands
                [ ]Department of Surgical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
                [ ]Department of Psychosocial Counseling, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
                [ ]Department of Adult Care, Virenze Institute of Mental Health Care, ‘t Goylaan 7, 3525 AA, Utrecht, The Netherlands
                Article
                1320
                10.1186/s12885-015-1320-z
                4423483
                25927495
                d5934cfc-d97a-43a4-b8a0-352685801097
                © Hummel et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 4 February 2015
                : 16 April 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Oncology & Radiotherapy
                breast cancer,sexual dysfunction,intimacy,cognitive behavioral therapy,internet-based,randomized controlled trial

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