Confirmatory Factor Analysis of the Sexual Adjustment and Body Image Scale in Women With Gynecologic Cancer

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1 Confirmatory Factor Analysis of the Sexual Adjustment and Body Image Scale in Women With Gynecologic Cancer Sarah E. Ferguson, MD 1 ; Sara Urowitz, PhD 2,3 ; Christine Massey, MSc 4 ; Marie Wegener, MD 1 ; NaaKwarley Quartey, BSc 4 ; David Wiljer, PhD 3,5 ; and Catherine C. Classen, PhD 2 BACKGROUND: There is evidence that treatment of gynecologic cancer (GC) negatively affects body image and sexuality. The Sexual Adjustment and Body Image Scale (SABIS-G) was developed to assess disturbances after diagnosis of GC. The objective of this study was to confirm the factor structure using a confirmatory factor analysis (CFA). METHODS: Women with a history of GC completed the SABIS-G, a 9-item self-report measure. Ninety randomly selected participants were used for the exploratory factor analysis (EFA). CFA was performed on the remaining participants (n ¼ 204) to confirm the factor structure developed in the EFA against a one-factor model. Test-retest reliability between baseline and follow-up scores was assessed using the intraclass correlation coefficient. RESULTS: A total of 614 eligible patients were approached to participate: 398 (65%) consented to the study and 294 (74%) completed the SABIS-G. The median age was 53 years (range, years) and the primary site of disease was: 120 (41%) uterine, 85 (29%) ovary, 82 (28%) cervix, and 7 (2%) other. A 2-factor structure was favored in the EFA, and the CFA fit indices indicated an excellent fit for the 2-factor measurement model (standardized root-mean-square residual ¼ 0.05, non-normed fit index ¼ 0.97, comparative fit index ¼ 0.98). Internal consistency reliability was high for the Body Image (0.88) and Sexual Adjustment (0.91) subscales, as was test-retest reliability (0.89). CONCLUSIONS: These results confirm the 2-factor structure of the SABIS-G and provide evidence that this is a valid and reliable instrument to measure changes in body image and sexuality in women after a diagnosis of GC. Cancer 2012;118: VC 2011 American Cancer Society. KEYWORDS: gynecologic cancer, sexuality, body image, psychometrics, questionnaire. The survival rates for women with gynecologic malignancies have improved significantly with advances in cancer treatment, resulting in a growing population of gynecologic cancer (GC) survivors. 1 It is estimated that there are greater than 1 million women in North America who are alive and who have been diagnosed and treated for a primary gynecologic malignancy within the last 20 years, making this the second largest group of female cancer survivors. 2,3 These women are often left with treatment-related adverse side effects which negatively impact their quality of life, including changes in sexuality and body image. Disturbances in sexuality and body image have been well documented in various patient populations with different types of GC and may be one of the most important factors impacting the quality of life for these women. 4-7 Up to 50% of women diagnosed with a gynecologic malignancy will have some aspect of sexual dysfunction after initial diagnosis, with more than 30% having long-term sexual dysfunction. 8 Whether a patient will experience distress due to these changes depends on both physical as well as psychosocial factors. The level of sexual functioning before cancer diagnosis, sexual self-schema, current history of depression and anxiety, and whether a patient has a supportive partner all may affect a patient s ability to adapt to these changes. 5,9,10 Corresponding author: Sarah E. Ferguson, MD, Assistant Professor, Department of Obstetrics and Gynecology, University of Toronto, Division of Gynecologic Oncology, Princess Margaret Hospital/University Health Network, 610 University Avenue, M-700, Toronto, Ontario, M5G 2M9, Canada; Fax: (416) ; Sarah. Ferguson@uhn.ca 1 Division of Gynecologic Oncology, Princess Margaret Hospital/Department of Obstetrics and Gynecology, University of Toronto, Toronto, Canada; 2 Department of Psychiatry, University of Toronto, Toronto, Canada; 3 Survivorship and Education, Princess Margaret Hospital, Toronto Canada; 4 Department of Biostatistics, Princess Margaret Hospital, Toronto, Canada; 5 Department of Radiation Oncology, Princess Margaret Hospital, Toronto, Canada. We thank Gerald Devins and Kenneth Mah for their statistical consultation and support. DOI: /cncr.26632, Received: July 26, 2011; Accepted: September 26, 2011, Published online December 2, 2011 in Wiley Online Library (wileyonlinelibrary.com) Cancer June 15,

2 Table 1. Sexual Adjustment and Body Image Scale (SABIS-G) This questionnaire was designed to help identify whether you have been negatively impacted by a change in your body image and sexuality since your gynecologic cancer diagnosis and treatment. BI1. After having cancer, how satisfied are you with your physical attractiveness? BI2. After having cancer, how comfortable are you with showing your body to others? BI3. How comfortable are you with the changes in your body after having cancer? SA1. After having cancer, how satisfied are you with your sex life? a SA2. After having cancer, how confident do you feel about yourself as a sexual partner? a SA3. How has having gynecologic cancer affected your desire for sexual contact? SA4. How has having gynecologic cancer affected your sexual relationship(s)? SA5. How has having gynecologic cancer affected how often you initiate sexual contact? SA6. How has having gynecologic cancer affected your sexual satisfaction when you have sex? a These two items were dropped from measure due to significant cross-loading on exploratory factor analysis. There is growing recognition among health care professionals of the impact of GC and its treatment on a woman s sexuality and body image. 11,12 Although the majority of health care providers believe sexuality is an important issue for women, fewer than half discuss these issues with their patients for multiple reasons, including lack of time and expertise. 11,12 Furthermore, identifying women who suffer from distress related to sexual dysfunction is challenging. Currently, there are no tools to help health care professionals identify women who have been negatively impacted by a change in their sexuality, and who may benefit from appropriate referral to sexual health experts or participation in intervention trials. Self-report measures exist to identify sexual dysfunction and sexual distress in women; however, these have been validated in populations who do not have cancer A body image scale for use in cancer patients has been developed to assess changes in body image for patients from all cancer sites; however, this was validated primarily in women with breast cancer. 18 The lack of a suitable scale to identify women adversely affected by changes in sexuality and body image due to GC led to the development and validation of a unique self-report measure based on a comparable tool developed for and validated in patients with breast cancer. 19 The primary objective of our study was to develop and validate the Sexual Adjustment and Body Image Scale for women with GC (SABIS-G) in order to identify women who have been negatively impacted by their diagnosis and treatment. MATERIALS AND METHODS Participants This study was a cross-sectional observational study approved by the Research Ethics Board at Princess Margaret Hospital/University Health Network, Toronto, Canada. Consecutive women were recruited from the gynecologic oncology outpatient clinics at Princess Margaret Hospital between June 2008 and January 2011 and informed consent was obtained. Eligibility criteria included adiagnosisofgc,noclinicalevidenceofdisease,noton active treatment or on treatment within the last 3 months, age >18 years and the ability to read and speak English. Patients were excluded if they had any major psychiatric illness or if they had current suicidal ideation. Demographic data such as age, ethnicity, education, and level of employment were obtained from each participant. They were asked to identify themselves as heterosexual, homosexual, or bisexual and if they were currently in a sexual relationship. Clinical data such as disease site and stage of disease, treatment, menopausal status, and use of hormonal replacement therapy before and after cancer diagnosis was obtained from the medical record. Scale Development The Sexuality and Body Image Scale for women with GC (SABIS-G) was modified from the validated SABIS for women with breast cancer. 19 Questions related to breast cancer surgery were removed, because these were not relevant to our patient population. All items in this modified version were reviewed for content by 2 psychotherapists with expertise in sexual functioning and 2 physicians with expertise in treating women with GC. The final version of the SABIS-G used for this analysis consisted of a 9-item measure with 3 items related to body image and 6 related to sexual adjustment (Table 1). Study Procedures Once informed consent was obtained, participants were asked to complete the self-report measures either in the outpatient clinic, or if they chose to complete at a later time, pre-paid envelops were provided to return the questionnaires by mail. If the questionnaires were not received 3096 Cancer June 15, 2012

3 Sexuality Scale for Gynecologic Cancer/Ferguson et al within 2 weeks, participants received a follow-up telephone call to remind them to mail in their questionnaires. Instruments The questionnaires completed at initial assessment included the SABIS-G, the Revised Female Sexual Distress Scale (FSDS-R), the Female Sexual Functioning Index (FSFI), Hospital Anxiety and Depression Scale (HADS), and Illness Intrusiveness Ratings Scale (IIRS). In addition, participants were asked to complete the SABIS-G 4 weeks after initial assessment in order to determine the test-retest reliability of this measure. Sexual distress was assessed using the FSDS-R which is a 13-item self-report scale that measures sexually-related personal distress in women. The FSDS-R has high testretest reliability (>0.74) and internal consistency (>0.86). 16 Higher scores indicate high sexual distress. Sexual functioning was measured using the FSFI, which is a 19-item multiple-choice questionnaire assessing 5 domains of sexual function in women. 15 Validation studies on sexually dysfunctional and matched control women have demonstrated excellent internal consistency ( ) and test-retest reliability ( ). High scores indicate better functioning. Anxiety and depression were assessed using the HADS, which is a 14-item self-report measure that has been found to be reliable and valid in a hospital outpatient setting. 20 The IIRS was used to assess the extent to which one s illness and or its treatment interferes with each of 13 life domains important to quality of life. 21 It has high internal consistency ( ), test-retest reliability (>0.79), and good validity. 22 Statistical Analyses An exploratory factor analysis (EFA) was performed on a random subset of the total sample to identify the initial factor structure. The necessary sample size for the EFA was based on a minimum of 10 participants per item and therefore the sample size was determined to be 90 for this 9-item measure. 23 The EFA was performed using a maximum-likelihood analysis with Promax (oblique) rotation. The number of factors was determined by interpretability, scree plots, retaining factors with eigenvalues greater than 1, and chi-square tests. Loading on a particular factor was considered adequate if it exceeded 0.3 and did not load significantly on other factors. Cronbach s coefficient alpha was calculated as a measure of internal consistency reliability for subscales. TheinitialfactorstructureidentifiedintheEFAprovided the hypothesized factor structure for the separate Maximum-likelihood CFA of covariance to be performed on the remaining participants. An adequate sample size for CFA is estimated to be approximately Acceptable fit of the model was defined as: the root-mean-square error of approximation (RMSEA) < 0.1, the standardized rootmean-square residual (SRMR) < 0.08 and all the goodness-of-fit indices >0.9, which include Bentler and Bonett s Non-Normed Fit Index (NNFI), Bentler s Comparative Fit Index (CFI), Goodness of Fit Index (GFI), and Adjusted Goodness of Fit (AGFI). Residuals were also examined with the expectation that a well-fitting model would have reasonably small and approximately normally distributed values. A chi-square test was implemented comparing the hypothesized model against a one-factor model, to test for evidence that the SABIS-G is measuring 2 distinct correlated constructs. Composite reliability was calculated for each subscale using the method described by Bollen as an additional measure of internal consistency and reliability. 25 The test-retest reliability was estimated using the intraclass correlation coefficient (ICC). Spearman correlation coefficients between the SABIS-G and the other instruments were calculated as measures of construct validity. To test concurrent validity, the SABIS-G was correlated with FSDS-R, which is an instrument that measures theoretically similar constructs. In addition, an item from the IIRS that asks how the illness and its treatment interferes with their sex life was used to assess concurrent validity. Measures that assessed theoretically related constructs were used to test convergent validity by correlating them with the SABIS-G. These measures included the HADS, the FSFI, and the relationship with partner item from the IIRS. Discriminant validity was tested by correlating the SABIS-G with a selected item from the IIRS that measures a theoretically unrelated construct (religion). The proportion of women who met the clinical cutoff for sexual distress by the FSDS-R (11) and for sexual dysfunction by the FSFI (26) was determined and the median SABIS-G scores for those 2 groups were compared. Known-groups validity was assessed using the Wilcoxon rank sum test (for binary variables) or the Kruskal-Wallis test to determine if SABIS-G scores vary with patient- and treatment-related variables. RESULTS A total of 627 patients were identified and approached for the study. Thirteen were not eligible due to evidence Cancer June 15,

4 Figure 1. Diagram shows the process by which study participants were selected and excluded. of recurrent disease, currently being on active treatment, or did not have a diagnosis of GC (Fig. 1). Six hundred and fourteen women were approached and were eligible for the study, and 398 (64.8%) consented to participate in the study. Of the 398 who consented to the study, 90 (22.6%) women did not return the questionnaires and therefore were considered to have dropped out of the study, and 308 (77.4%) returned the questionnaires; however, only 294 (73.8%) had completed all items of the SABIS-G and these participants were used for the final analysis. Of those women who returned the completed questionnaires, 210 (71.4%) returned the 4-week SABIS-G. The demographic and clinical characteristics of the participants are presented in Tables 2 and 3. There were no clinically significant differences in these characteristics between the participants in the EFA compared to those in the CFA. To ensure that patients who completed the questionnaires were not systematically different from those who dropped out, we compared the clinical characteristics between participants who consented to the study Table 2. Demographic Characteristics of Study Participants Variable Total Cohort N EFA N 5 90 CFA N Median age (range), y 53.3 ( ) 52.7 ( ) 54.3 ( ) Language in the home N ¼ 293 (%) N ¼ 90 (%) N ¼ 203 (%) English only 216 (73.7) 60 (66.7) 156 (76.8) English and other 77 (26.3) 30 (33.3) 47 (23.2) Ethnicity N ¼ 293 (%) N ¼ 90 (%) N ¼ 203 (%) White 239 (81.6) 72 (80.0) 167 (82.3) Asian 20 (6.8) 7 (7.8) 13 (6.4) Black 10 (3.4) 5 (5.6) 5 (2.5) Other 24 (8.2) 6 (6.7) 18 (8.9) Educational level N ¼ 293 (%) N ¼ 90 (%) N ¼ 203 (%) Some postgraduate 46 (15.7) 14 (15.6) 32 (15.8) Some college/university 175 (59.7) 51 (56.7) 124 (61.1) Some high school 65 (22.2) 23 (25.6) 42 (20.7) Other 7 (2.4) 2 (2.2) 5 (2.5) Partner/spouse N ¼ 294 (%) N ¼ 90 (%) N ¼ 204 (%) Yes 240 (81.6) 76 (84.4) 164 (80.4) No 54 (18.4) 14 (15.6) 40 (19.6) Sexual orientation N ¼ 275 (%) N ¼ 82 (%) N ¼ 193 (%) Heterosexual 260 (94.5) 77 (93.9) 183 (94.8) Homosexual 3 (1.1) 0 3 (1.6) Bisexual 4 (1.5) 1 (1.2) 3 (1.6) Do not want to answer 8 (2.9) 4 (4.9) 4 (2.1) Currently sexually active N ¼ 294 (%) N ¼ 90 (%) N ¼ 204 (%) Yes 196 (66.7) 60 (66.7) 136 (66.7) No 98 (33.3) 30 (33.3) 68 (33.3) 3098 Cancer June 15, 2012

5 Sexuality Scale for Gynecologic Cancer/Ferguson et al Table 3. Clinical Characteristics of the Study Participants Variable Total Cohort (%) N EFA (%) N 5 90 CFA (%) N Primary disease site Endometrium/uterus 120 (40.8) 33 (36.7) 87 (42.6) Ovary/FT/PPC 85 (28.9) 27 (30) 58 (28.4) Cervix 82 (27.9) 30 (33.3) 52 (25.5) Other 7 (2.4) 0 7 (2.4) FIGO stage I 193 (65.6) 56 (62.2) 137 (67.2) II 54 (18.4) 17 (18.9) 37 (18.1) III 42 (14.3) 14 (15.6) 28 (13.7) IV 5 (1.7) 3 (3.3) 2 (1) Surgery Yes 252 (85.7) 74 (82.2) 178 (87.3) No 42 (14.3) 16 (17.8) 26 (12.7) Radiation Yes 138 (46.9) 43 (47.8) 95 (46.6) No 156 (53.1) 47 (52.2) 109 (53.4) Chemotherapy Yes 135 (45.9) 50 (55.6) 85 (41.7) No 159 (54.1) 40 (44.4) 119 (58.3) Treatment Surgery alone 105 (35.7) 28 (31.1) 77 (37.7) Surgery/RT 52 (17.7) 11 (12.2) 41 (20.1) Surgery/chemotherapy/RT 48 (16.3) 16 (17.8) 32 (15.7) Surgery/chemotherapy 47 (16) 19 (21.1) 28 (13.7) Chemotherapy and RT 36 (12.2) 15 (16.7) 21 (10.3) Chemotherapy alone 4 (1.4) 0 4 (2.0) RT alone 2(<1) 1 (1.1) 1 (0.5) Menopausal before treatment Yes 137 (46.6) 40 (44.4) 97 (47.5) No 157 (53.4) 50 (55.6) 107 (52.5) Menopausal after treatment Yes 264 (89.8) 85 (94.4) 179 (87.7) No 30 (10.2) 5 (5.6) 25 (12.3) Hormone replacement therapy N ¼ 290 N ¼ 89 N ¼ 201 after treatment Yes 54 (18.6) 23 (25.8) 31 (15.4) No 236 (81.4) 66 (74.2) 170 (84.6) Abbreviations: CFA, confirmatory factor analysis; EFA, exploratory factor analysis; FIGO, International Federation of Gynecology and Obstetrics; FT, fallopian tube; PP, primary peritoneal; RT, radiotherapy. but did not complete the SABIS-G (dropouts, N ¼ 90) and those that did complete the SABIS-G (N ¼ 294) (data not shown). There were no statistically significant differences in the clinical characteristics between the study population and the dropouts (all P values >.05). The median age of the entire cohort at the time of diagnosis of their GC was 50.3 (range, ) with the median age at time of consenting to the study of 53.3 (range, ). There was a median of 2.1 years (range, ) from time of GC diagnosis to participation in the study. The majority of patients had early stage disease (247, 84%) and there was a good distribution of disease site, with 120 (40.8%) having endometrial/uterine cancer, 85 (28.9%) having ovarian cancer, and 82 (27.9%) having cervical cancer. The majority of women had multimodality therapy (183, 62%), and 127 (43.2%) had treatment-induced menopause. Most women were heterosexual (94.5%) and had a partner (81.6%); however, only two-thirds were currently sexually active. There were 64.6% (184/285) of women who had sexual distress Cancer June 15,

6 Table 4. Exploratory Factor Analysis: Factor Loadings Rotated Factor Pattern (Standardized Regression Coefficients) Variable Factor 1 Factor 2 SABIS-G-BI SABIS-G-BI SABIS-G-BI SABIS-G-SA SABIS-G-SA SABIS-G-SA SABIS-G-SA Abbreviations: BI, body image; SA, sexual adjustment; SABIS-G, Sexual Adjustment and Body Image Scale for women with gynecologic cancer. as measured by the FSDS-R and 76.1% (204/268) who had sexual dysfunction as measured by the FSFI based on clinical cutoffs determined in noncancer populations. Exploratory Factor Analysis The EFA revealed a 2-factor solution based on the criteria of retaining factors with eigenvalues greater than one, the scree plot, interpretability, and chi-square tests. A chisquare test rejected the hypothesis that there were no underlying factors and did not reject the hypothesis that 2 factors were sufficient. Two constructs were suggested with 3 variables related most strongly to disturbances in body image (BI1 to BI3) and 6 variables related most strongly to disturbances in sexual adjustment (SA1 to SA6) (Table 1). Most variables had quite high loadings on one factor and quite low loadings on the other factor. However, one of the sexual adjustment variables (SA2) loaded significantly on both factors with a coefficient of 0.65 for one factor and 0.31 on the second factor, suggesting that it may be measuring components of both sexual adjustment and body image. Another variable (SA1) did not behave as cleanly as the remaining items, with coefficients of 0.65 and A 3-factor maximum likelihood analysis was performed for exploratory purposes and this analysis revealed SA1 to be loading significantly on its original factor (coefficient ¼ 0.4) as well as a third factor (coefficient ¼ 0.58), implying that it may be measuring not just sexual adjustment but another unidentified factor. Based on the significant cross-loading of these 2 sexual adjustment variables (SA1 and SA2) they were removed and the analysis was performed with the remaining 7 variables (BI 1 to BI3 and SA3 to SA6). The EFA again revealed a 2-factor solution with the same three body image variables and four sexual adjustment variables loading highly together without evidence of cross loading (Table 4). The average intervariable correlation for the body image subscale was 0.72 (range, ), and for the sexual adjustment subscale was 0.71 (range, ). Both subscales demonstrated good internal consistency, with Cronbach s alpha of 0.88 for body image and 0.91 for sexual adjustment. Confirmatory Factor Analysis The CFA was performed on 204 participants using the revised 7-item SABIS-G and the defined model which demonstrated an excellent fit to the data (RMSEA ¼ 0.08, SRMR ¼ 0.05). All the goodness of fit indices were greater than 0.9 (NNFI ¼ 0.97, CFI ¼ 0.98, GFI ¼ 0.96, and AFGI ¼ 0.91). The Student t tests for factor loading were all highly significant (P <.001) In addition, the 2- factor model provided significantly better fit over a 1-factor model (P <.001) suggesting that the SABIS-G is measuring 2 correlated but distinct constructs, and there were no large residuals. The estimated composite reliability for body image was 0.82 and sexual adjustment The estimated correlation between the body image and sexual adjustment subscale was 0.40 (95% CI, , P <.001) for the 7-item SABIS-G. SABIS-G Scoring To score the SABIS-G each variable was scored from 1 to 5, with 5 as the best outcome. The body image subscale sum ranges from 3 to 15 and the sexual adjustment subscale sum ranges from 4 to 20. To calculate the SABIS-G overall score, we first created a weighted sum of the 2 subscale sums by multiplying the body image subscale sum by 4, the sexual adjustment subscale sum by 3, and adding the 2 results. This way, both subscales range between 12 to 60 and the weighted sum ranges between 24 and 120. Next, we applied a linear transformation so that the weighted sum ranges between 0 and 100, in order to facilitate interpretation of SABIS-G scores. This is accomplished by subtracting the minimum possible score (24) from the weighted sum, then dividing this new value by the range (96), and finally multiplying the result by 100. Higher scores indicate better outcomes. The median score in our total population was 41.7 (range, 0-100). The median SABIS-G score for women who met the clinical cutoff of sexual distress as measured by the FSDS-R was 33.3 (range, 0-76) compared to 50 (range, ) in those who did not meet this clinical cutoff (P <.0001). The SABIS-G scores for women who had clinical cutoff score on the FSFI of 26 was 36.5 (range, 0-76), which was significantly lower than the SABIS-G score of 54.2 (range, ) in women who 3100 Cancer June 15, 2012

7 Sexuality Scale for Gynecologic Cancer/Ferguson et al Table 5. Spearman Correlation Between SABIS-G and Other Instruments Instrument N Range of Possible Values Mean Score SD Spearman Correlation Coefficient Lower 95% CI Upper 95% CI FSDS-R FSFI HADS (anxiety) HADS (depression) IIRS IIRS (sex life) IIRS (relationship with spouse) IIRS (religious expression) Abbreviations: CI, confidence interval; FSFI, Female Sexual Functioning Index; FSDS-R, Revised Female Sexual Distress Scale; HADS, Hospital Anxiety and Depression Scale; IIRS, Illness Intrusiveness Ratings Scale; SD, standard deviation; SABIS-G, Sexual Adjustment and Body Image Scale for women with gynecologic cancer. did not meet this clinical cutoff for sexual dysfunction (P <.0001). The test-retest reliability of the SABIS-G measured by the ICC was The median time between baseline SABIS-G completion and the four week followup SABIS-G was 1.25 months (range, ). Validity Testing All the correlations between the SABIS-G scores and the other instruments administered are statistically significant and in the expected direction (P <.01). The estimated correlation between the SABIS-G and the FSDS-R is 0.61 which demonstrates concurrent validity (Table 5). The estimated correlation between how their illness interferes with their sex life from the IIRS and the SABIS-G was 0.68, which also demonstrates concurrent validity (Table 5). The moderate correlations between the SABIS-G and the FSFI, the anxiety and depression subscales of the HADS and the relationship with spouse/partner item from the IIRS demonstrate convergent validity (Table 5). The lower correlations with the religion item from the IIRS demonstrate discriminant validity (Table 5). To test for known-groups validity, the overall SABIS-G scores were compared between different patient groups (Table 6). There were significant differences in the overall SABIS-G scores between women undergoing different treatment regimens. For women who had combination radiation with chemotherapy with or without surgery, the median SABIS-G score was 34.9 (range, 0-74) which was significantly lower than the median SABIS-G score of 42.7 (range, 0-100) in women who had other treatment combinations that included surgery alone, surgery and chemotherapy, or surgery and radiotherapy (P ¼.01). The SABIS-G scores in women were significantly different depending on the primary site of disease. Women with cervical cancer had significantly lower scores than all other cancer sites (Table 6). Women with cervical cancer that was treated with concurrent radiation and chemotherapy or surgery followed by concurrent radiation and chemotherapy had SABIS-G score of 32.3 (N ¼ 49; range, ). This was significantly lower than the SABIS-G score of 41.7 (N ¼ 245; range, 0-100, P ¼.03) for all other patients regardless of disease site or treatment. Women who experienced treatment-induced menopause had significantly lower overall SABIS-G scores compared with women who had no change in their menopausal status (Table 6). DISCUSSION Although the negative impact of GC on sexuality and body image is known, there has been a lack of a measure to assess sexual disturbances in this population. The SABIS-G was developed specifically for this unique group of cancer survivors to identify women with disturbances in their sexuality secondary to this diagnosis and its associated treatments. The SABIS-G was evaluated in women with all types of GC who were currently not on treatment and without disease recurrence. The initial exploratory factor analysis identified 2 problematic items which were subsequently removed. EFA on the modified measure showed that the items clustered into 2 distinct but correlated constructs that corresponded to changes in a woman s body image and sexuality. The new 7-item measure was evaluated in a new population of GC survivors and the hypothesized 2-factor model was confirmed using CFA. The SABIS-G was found to have excellent internal consistency reliability and retest reliability. The moderate positive correlation with other measures such as the FSDS-R, which measures sexually related personal distress, and the FSFI, which measures sexual dysfunction in women without a cancer diagnosis, Cancer June 15,

8 Table 6. SABIS-G Scores Between Different Patient Groups Clinical Variables N Median Range P Treatment Radiation/chemotherapy Surgery Surgery/chemotherapy Surgery/radiation Surgery/radiation/chemotherapy Surgery Yes No Radiation Yes No Treatment-induced menopause <.001 Yes No FIGO stage I II III IV Primary site Cervix Uterus Ovary Other Primary site Cervix All other sites Abbreviations: FIGO, International Federation of Gynecology and Obstetrics; SABIS-G, Sexual Adjustment and Body Image Scale for women with gynecologic cancer. indicates that the SABIS-G is able to measure similar and related constructs and by definition has good construct validity. The moderate correlation with these general measures of sexuality is expected, because the SABIS-G is measuring the negative effects of GC treatment on a woman s sexuality and body image specifically. This instrument has also shown it can discriminate between different groups of women treated for GC who are known to have different sexual outcomes. Women who enter menopause prematurely due to radiation, chemotherapy, or surgery often have significant persistent effects due to lack of estrogen. 26,27 These symptoms can include hot flashes, sleep disturbances, and vaginal atrophy. In our study, women who were left with treatmentinduced menopause had significantly lower SABIS-G scores than women who were already post-menopausal or did not enter the menopause secondary to cancer treatment, indicating that this measure was able to discriminate between these 2 groups that are known to have different sexual outcomes. 28 In addition, women with cervical cancer who underwent radiation combined with chemotherapy used adjuvantly after surgery or for definitive treatment had lower SABIS-G scores compared to those women with GC, regardless of primary disease site, treated with surgery alone or surgery followed by radiation or chemotherapy. These women are left with significant changes in the vagina due to radiation, such as thinning of the vaginal mucosa, vaginal dryness, and narrowing of the vagina with associated dyspareunia, and are known to have significant problems with sexual functioning that usually persists. 29,30 In addition, women with a diagnosis of cervical cancer who often undergo multimodality therapy including concurrent radiation and chemotherapy and brachytherapy had lower scores compared to women with other cancer types. These results indicate that the SABIS-G has good discriminant validity and is able to differentiate different groups of women who are more negatively affected by their cancer treatment Cancer June 15, 2012

9 Sexuality Scale for Gynecologic Cancer/Ferguson et al One of the limitations of this study is that we have yet to establish a firm clinical cutoff score for the SABIS-G. One potential method to establish a cutoff score would be to compare the SABIS-G scores before and after cancer treatment. However, this would unlikely reflect the true baseline in these women, because unlike other cancer populations, women with GC have symptoms from their cancer, such as pelvic pain and vaginal bleeding, that affect their sexual functioning long before their diagnosis and treatment. The other method would be to compare this population to an age-matched noncancer population. However, the SABIS-G would have to be significantly modified, because the questions specifically ask about changes in sexuality and body image due to the treatment of GC and would make the validity of such a comparison questionable. The range of SABIS-G scores from 0 to 100, with a score of 0 indicating worst disturbances and a score of 100 indicating no disturbances in sexuality and body image, acts like a visual analogue scale and gives some reference for the clinical significance of these disturbances in sexuality. In our population, the median score was 41.7 which shows that the diagnosis and treatment of GC negatively impacts sexuality and body image in these women. In addition, the median scores for the FSFI and FSDS-R in these women after treatment for GC met the clinical cutoffs for sexual dysfunction and sexual distress determined for women without a cancer diagnosis. 17,31 The SABIS-G is a validated brief self-report measure that can be used to identify women who have found the treatment of their GC has caused significant adverse changes in their sexuality and body image. The area of sexual health in oncology is becoming an important area of survivorship research and care. Physicians are beginning to understand the importance of this persistent effect of treatment. The SABIS-G could be used as a quick screening tool that patients can complete themselves. This may facilitate proper referral to programs for sexual health offered by some cancer centers or identify women that may benefit by participating in clinical trials looking at innovative ways to help women manage changes in sexuality and body disturbance related to GC treatment. FUNDING SOURCES This research was funded by the Mount Sinai Hospital Department of Obstetrics Research Fund and the Princess Margaret Hospital Foundation, Toronto, Canada. CONFLICT OF INTEREST DISCLOSURE The authors made no disclosure. REFERENCES 1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, CA Cancer J Clin. 2010;60: Canadian Cancer Society s Steering Committee. Canadian Cancer Statistics Toronto, Canada: Canadian Cancer Society; National Cancer Institute, Division of Cancer Control and Population Sciences. Cancer Survivorship Research: Estimated U.S. Cancer Prevalence. Available at: cancer.gov/ocs/prevalence/prevalence.html#female. Accessed May 31, Andersen BL, Anderson B, deprosse C. Controlled prospective longitudinal study of women with cancer: I. Sexual functioning outcomes. J Consult Clin Psychol. 1989;57: Anderson BL. Predicting and treating the sexual difficulties of gynecologic cancer survivors. Cancer Control. 1996;3: Andersen BL. Sexual functioning complications in women with gynecologic cancer. Outcomes and directions for prevention. Cancer. 1987;60(8 suppl): Carter J, Auchincloss S, Sonoda Y, Krychman M. Cervical cancer: issues of sexuality and fertility. Oncology (Williston Park). 2003;17: Andersen BL, van Der Does J. Surviving gynecologic cancer and coping with sexual morbidity: an international problem. Int J Gynecol Cancer. 1994;4: Cleary V, Hegarty J, McCarthy G. Sexuality in Irish women with gynecologic cancer. Oncol Nurs Forum. 2011;38:E87-E Carpenter KM, Andersen BL, Fowler JM, Maxwell GL. Sexual self schema as a moderator of sexual and psychological outcomes for gynecologic cancer survivors. Arch Sex Behav. 2009;38: Wiggins DL, Wood R, Granai CO, Dizon DS. Sex, intimacy, and the gynecologic oncologists: survey results of the New England Association of Gynecologic Oncologists (NEAGO). J Psychosoc Oncol. 2007;25: Stead ML, Brown JM, Fallowfield L, Selby P. Lack of communication between healthcare professionals and women with ovarian cancer about sexual issues. Br J Cancer. 2003;88: Thirlaway K, Fallowfield L, Cuzick J. The Sexual Activity Questionnaire: a measure of women s sexual functioning. Qual Life Res. 1996;5: Stead ML, Crocombe WD, Fallowfield LJ, et al. Sexual activity questionnaires in clinical trials: acceptability to patients with gynaecological disorders. Br J Obstet Gynaecol. 1999;106: Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26: Derogatis L, Clayton A, Lewis-D Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5: Derogatis LR, Rosen R, Leiblum S, Burnett A, Heiman J. The Female Sexual Distress Scale (FSDS): initial validation Cancer June 15,

10 of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther. 2002;28: Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001;37: Dalton EJ, Rasmussen VN, Classen CC, et al. Sexual Adjustment and Body Image Scale (SABIS): a new measure for breast cancer patients. Breast J. 2009;15: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67: Devins GM, Dion R, Pelletier LG, et al. Structure of lifestyle disruptions in chronic disease: a confirmatory factor analysis of the Illness Intrusiveness Ratings Scale. Med Care. 2001;39: Devins GM. Using the illness intrusiveness ratings scale to understand health-related quality of life in chronic disease. J Psychosom Res. 2011;68: Nunnally JC. Psychometric Theory. 2nd ed. New York, NY: McGraw-Hill; Tabachnick BG, Fidell LS. Using Multivariate Statistics. 4th ed. Boston, MA: Allyn & Bacon; Bollen KA. Structural Equations With Latent Variables. New York, NY: Wiley; Ratner ES, Foran KA, Schwartz PE, Minkin MJ. Sexuality and intimacy after gynecological cancer. Maturitas. 2010;66: Krychman ML, Pereira L, Carter J, Amsterdam A. Sexual oncology: sexual health issues in women with cancer. Oncology. 2006;71: Ganz PA, Desmond KA, Belin TR, Meyerowitz BE, Rowland JH. Predictors of sexual health in women after a breast cancer diagnosis. J Clin Oncol. 1999;17: Schover LR, Fife M, Gershenson DM. Sexual dysfunction and treatment for early stage cervical cancer. Cancer. 1989;63: Bergmark K, Avall-Lundqvist E, Dickman PW, Henningsohn L, Steineck G. Vaginal changes and sexuality in women with a history of cervical cancer. N Engl J Med. 1999;340: Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31: Cancer June 15, 2012