Baseline Characteristics and Concerns of Female Cancer Patients/Survivors Seeking Treatment at a Female Sexual Medicine Program

Introduction

With the US population of cancer survivors expected to grow to 18 million by 2020 [1], quality of life (QOL), including issues of sexual function and vaginal health, will require more attention [2–4].

Substantial sexual/vaginal health concerns have been identified in recent surveys [5–8]. Although the normal aging process prompts physical changes that influence sexual function and vaginal health, with more than half of all women experiencing vulvovaginal atrophy after menopause, cancer and its treatment can compound these issues or induce symptoms earlier. The loss of genital tissue elasticity and lubrication often causes vaginal dryness and discomfort, and can lead to pain with gynecologic examinations—a crucial component of cancer surveillance. These changes can also cause dyspareunia in some women and consequent loss of sexual desire [9–11]. Estrogen deprivation and/or menopause triggered by cancer treatment is typically abrupt, with more intense and/or prolonged symptoms, including hot flashes, vaginal dryness, and dyspareunia [12–15]. When women are treated for cancer with pelvic radiation, systemic chemotherapy, and/or endocrine therapies such as aromatase inhibitors, vaginal atrophy is often more severe [15]. Female cancer patients and survivors report interest in sexual and vaginal health resources but few receive care [5,8].

The Female Sexual Medicine and Women’s Health Program (FSMWHP) at Memorial Sloan Kettering Cancer Center (MSKCC) was established to address the consequences of cancer treatment on vaginal health and sexuality. The goal of the FSMWHP is to provide information, strategies, and support to improve vaginal symptoms and enhance confidence about sexual/vaginal health while simultaneously promoting evidence-based research. It was designed to be a two-clinician program consisting of a PhD clinical psychologist (certified as a sexual therapist) and a nurse practitioner (NP). Each new visit consists of a consultation with both the PhD and NP together, including a formal intake reviewing medical and psychosexual history and specific information about the patient’s sexual/vaginal health symptoms and concerns, followed by a targeted pelvic examination by the NP and finishing with a final discussion consisting of sexual/vaginal health promotion strategies and a treatment plan for the patient. This model enables the provision of comprehensive, quality care addressing both the emotional and physical effects of cancer in a clinically feasible and timely manner. Women are mainly referred to the program by their medical team, although some are self-referred. All women seen at the program are patients who received or are currently receiving treatment for their cancer at MSKCC.

The objectives of this clinical care assessment study are to characterize those seeking treatment at the FSMWHP, to examine the severity of patients’ sexual health issues and concerns identified at their initial consultation, and to compare patient demographic and medical characteristics between patient groups defined by select sexual and vaginal health outcomes of interest. This information will be helpful in understanding patterns of need and referrals to the FSMWHP in order to assist in patient outreach efforts and tailored clinical interventions for women diagnosed with cancer.

Materials and Methods

A limited waiver of authorization was obtained to evaluate new-visit data collected on an FSMWHP clinical assessment form from 02/2011 to 07/2013. Of 509 new-visit patients, 493 (97%) completed the form.

The FSMWHP clinical assessment form consists of both clinician- and patient-completed portions. Vaginal health is assessed by clinician-rated (PhD/NP) physical vaginal characteristics based on the clinical pelvic/gynecological exam (agglutination, scarring/adhesions, pH, moisture, rugosity, elasticity, length, thickness, epithelial integrity, and vascularity [defined in Table 3]), as well as by the Vaginal Assessment Scale (VAS)—a 4-item measure in which the clinician asks patients to classify their perceptions of vaginal dryness, soreness, irritation, and dyspareunia as None, Mild, Moderate, or Severe. Each item is transformed to a numeric scale (0=None to 3=Severe). The VAS Composite score (range, 0–3) is formed by taking the mean of the items and is calculated only when at least 2/4 items are not missing. Due to NP staff changes, only 253 women received a pelvic examination. Similarly, the VAS was added to the FSMWHP clinical assessment form as of 02/2012 and was administered to 265 women at their initial consultation.

The clinician also asks patients how often they use vaginal health promotion strategies (vaginal lubricant, internal vaginal moisturizers, pelvic floor exercises, and dilators), and notes the frequency of use on the FSMWHP clinical assessment form, as well as whether the strategy was recommended at the visit as part of the patient’s FSMWHP treatment plan.

The remainder of the FSMWHP clinical assessment form is patient-completed and includes the following validated patient-reported outcome (PRO) measures:

Female Sexual Function Index (FSFI) – a brief self-report of female sexual function [16] recently validated in female cancer survivors [17]. It is a 19-item questionnaire assessing six domains of sexual function: 1) desire, 2) subjective arousal, 3) lubrication, 4) orgasm, 5) satisfaction, and 6) pain/discomfort. A total score greater than 26.55 indicates no sexual dysfunction.

Sexual Activity Questionnaire (SAQ) – a short and discrete screening tool for sexual activity and sexual function [18]. It is a 14-item self-report instrument assessing whether women are engaging in sexual activity with someone, reasons for any reported inactivity, and sexual feelings and experiences over the previous month [19].

Sexual Self-Schema Scale (SSS) – a self-rated assessment about the sexual aspects of one’s sexual self [20]. It contains 26 scored trait adjectives (i.e., cautious, loving, open-minded) plus 24 adjective fillers (i.e., generous, practical, kind) that are rated from 0 (not at all descriptive of me) to 6 (very descriptive of me). The items measure three dimensions: 1) loving-romantic, 2) direct-open, and 3) embarrassment-conservatism. The total score is the sum of the first two dimensions minus the third. Internal consistency for the total score is 0.75. Scores are stable over time, with 2-week and 2-month test-retest reliability estimates of 0.89 and 0.88, respectively. A score above 59 indicates a positive sexual self schema [21].

Exploratory items addressing sexual/vaginal health were also included:

“Do you feel confident about sexual activity in the future?” (Yes/No), and

“How concerned or worried are you about your sexual function and your vaginal health?” (0–10 visual analogue scale with anchors at 0=Not at all, 5=Somewhat, and 10=Very).

We classified women as sexually active/inactive using two distinct methods. The first classifies women as sexually active if they answered “Yes” to SAQ item #3: “Do you engage in sexual activity with anyone at the moment?” The second classifies women as sexually active/inactive according to their FSFI responses. Patients who skipped or responded “not sexually active” to at least half of the 15 FSFI items with this response option were considered sexually inactive [17,22]. We refer to the versions as sexual activity (SAQ) and sexual activity (FSFI) in the remainder of the manuscript. The former definition (SAQ) is direct, but precludes self-stimulation and assesses sexual activity during an ambiguous timeframe (i.e., “at the moment”). The latter definition (FSFI) includes self-stimulation, assesses activity during a clear timeframe (i.e., “over the past 4 weeks”), and may be more sensitive to small changes in sexual activity.

We calculated descriptive statistics (frequencies and percentages for categorical variables, means, and standard deviations for continuous variables) for demographic, medical, and clinical assessment form variables. In an exploratory analysis, we also compared these characteristics between groups defined by four dichotomous variables of interest: sexual activity (FSFI), pain during pelvic exam, confidence about sexual activity in the future, and satisfaction with sexual relationship with partner (defined as responses to FSFI #15 of “very satisfied” or “moderately satisfied” versus “about equally satisfied and dissatisfied”, “moderately dissatisfied”, or “very dissatisfied”). Statistical significance of group differences was evaluated using Fisher’s exact test (categorical variables) and two-sample t-tests (continuous variables). Significance tests with p<0.05 were considered statistically significant, and those with p<0.10 were considered marginally significant. All statistical analysis was conducted in R 3.0.2 [23].

Results

Discussion

Our investigation of the baseline characteristics and needs of women receiving care at the FSMWHP suggests that predominantly breast and gynecologic cancer patients are referred to the FSMWHP. We recognize the need for future outreach to other populations. Referrals were for sexual function concerns but also consisted of requests for assistance with vaginal health concerns, such as reducing pain with gynecologic exams or vulvovaginal discomfort.

At initial consult, women attending the FSMWHP noted symptoms of vaginal dryness and pain/dyspareunia. For many women, pelvic exams revealed signs of vaginal atrophy including elevated vaginal pH, lack of moisture, and discomfort with the examination itself. Interestingly, increased pain with exam was associated with good rugosity. Loss of vaginal rugae or folds in the vagina is a sign of aging or lower estrogen. We propose that this may be an indication of changes in lubrication and moisture before tissue decline has had time to occur, but examination of changes over time are needed to help elucidate this finding. Substantial concerns about sexual and vaginal health were expressed by women seeking treatment at the FSMWHP. Less than half of the women felt confident about future sexual activity, which corresponded with their rates of SAQ sexual activity (53%). Of the women who were sexually inactive (47%), physical problems or lack of interest were cited as the main reasons for lack of activity. Not surprising, sexual dysfunction was reported by the majority of FSMWHP participants, as per the FSFI. However, the directionality of the symptoms and sexual dysfunction, in addition to potential interactions between factors of confidence, sexual activity, interest, and relationship (satisfaction, closeness) need further investigation. For example, it is unclear if vaginal symptoms contribute to poor relationship quality or if poor relationship quality creates an unsupportive environment for addressing vaginal symptoms and declining sexual function, which then impacts confidence. Future analysis with longitudinal data will explore potential effects and patterns of directionality.

It should be noted that although sexuality is a priority for many cancer patients/survivors, for those unclear about this issue, vaginal health should remain a priority. These women represent an important group that is often forgotten. Vaginal health is crucial for comfort with gynecologic examinations—an essential component of cancer surveillance. In the general population, vulvovaginal atrophy is underreported and undertreated [24]. More than half of all women in natural menopause eventually will experience symptoms of vulvovaginal atrophy [25,26]. In a recent international survey of 3520 postmenopausal women, 45% reported vulvovaginal atrophy symptoms; and almost two-thirds (63%) did not recognize the chronicity of this condition [24]. In the setting of cancer, vulvovaginal atrophy can be more challenging with acute estrogen deprivation resulting from various cancer treatment modalities. Strategies are available to promote vaginal health, and female cancer survivors need basic advice and simple solutions.

Despite having over-the-counter options to address dryness and pain, less than one-third used lubricants routinely and less than one-quarter reported regular application of a moisturizer. These products can be extremely helpful if used with the frequency needed to address their symptoms (usually greater than the products’ recommendations), and they must be used consistently for benefit. Clinically, we have seen that relief of symptoms can contribute to increased vaginal comfort and confidence with sexual activity. Within the FSMWHP we routinely encourage women to apply moisturizer not only vaginally but also externally for overall comfort and treatment (and even prevention in some cases) of vulvovaginal atrophy symptoms.

There are several noted limitations of the study. Not all women underwent a gynecologic exam and the FSMWHP clinical assessment form underwent modifications, resulting in different denominators for some of the items. From a program development standpoint, the FSMWHP clinical assessment form modifications enhanced our ability to identify and meet the needs of our patients. It now includes greater detail assessing the internal and external genitalia both by the symptoms reported by our patients and clinical features on pelvic exam. Plans to validate this addition to our clinical assessment are underway.

Future FSMWHP evaluation will investigate differences between pre-menopausal and menopausal patients, as pain, satisfaction, loss of desire, and physical examination variables, as well as prospectively examine the compliance and benefit of sexual/vaginal health promotion strategies by assessing any potential changes over time on PROs and pelvic exam outcomes.

Supplementary Material