Abstract
Background
Women at high risk for breast and ovarian cancer have two major management options to reduce their risk of ovarian cancer, periodic screening (PS) or risk-reducing salpingo-oophorectomy (RRSO). Little is known regarding patient satisfaction levels with risk-reduction strategy. Thus, we sought to determine levels of patient satisfaction with PS versus RRSO and identify factors which may influence satisfaction.
Methods
As part of a larger study, women who received BRCA1/2 testing were sent a follow-up questionnaire packet to explore issues related to cancer risk-reduction. We report on the results of a variety of validated instruments including the Satisfaction With Decision (SWD) scale, focused on the choice between PS and RRSO.
Results
A total of 544 surveys were mailed and 313 responses were received (58%). The overall satisfaction rate among respondents was high. Median SWD score was significantly higher in patients in the RRSO group compared to the PS group (p<.001). BRCA mutation carriers had higher median SWD scores, regardless of management type (p=.01). Low satisfaction scores were associated with high levels of uncertainty and the perception that the decision between PS and RRSO was difficult to make (p=.001). Satisfaction was unrelated to demographics, clinical factors, or concerns of cancer risk.
Conclusion
In our study, the majority of women at high risk for breast and ovarian cancer were satisfied with their choice of risk-reduction strategy. Difficulty with decision making was associated with lower satisfaction levels. Improved education and support through the decision-making process may enhance overall levels of satisfaction.
Keywords: BRCA, Risk-Reduction, Ovarian Cancer, Breast Cancer, Satisfaction
Introduction
In 2009, ovarian cancer was the second most common gynecologic cancer in the United States, with an estimated incidence of 21,550 cases1. Of these new diagnoses, up to 10% are attributable to hereditary causes, including patients with known mutations in the BRCA 1 and BRCA 2 genes2–4. The lifetime risk of ovarian cancer for the general population is approximately 1.5%5. In contrast, BRCA mutation carriers have a lifetime risk of ovarian cancer which ranges between 16 – 50%, depending on the specific mutation4, 6. Additionally, women with a strong family history of breast and/or ovarian cancer who test negative for a known genetic mutation are at increased risk for this disease7. Thus, identification and treatment of women at high risk for ovarian cancer provides a significant opportunity for cancer prevention strategies.
Women at high risk for ovarian cancer are offered two major options for risk reduction, periodic screening (PS) or risk-reducing salpingo-oophorectomy (RRSO). PS consists of biannual pelvic examination with transvaginal ultrasound and serum CA-125 determination. To date, the efficacy of this risk-reduction strategy has not been clearly demonstrated8. RRSO is a surgical procedure involving removal of both ovaries and fallopian tubes and has been shown to have a definitive impact on cancer risk reduction. In general, RRSO provides an average ovarian cancer risk reduction of 80–96% and an additional breast cancer risk reduction of 50–60%9–12. However, many women do not choose this option due to desire for future fertility or concerns over adverse effects of early oophorectomy, such as menopausal symptoms.
Thus, exploration of the issues of quality of life and satisfaction in women undergoing RRSO is paramount. Current literature indicates overall quality of life is quite similar among high risk patients regardless of choice of risk-reduction strategy, PS versus RRSO13, 14. However, there are conflicting data which demonstrate that despite reporting equivalent overall satisfaction, PS patients have higher levels of regret when compared to RRSO patients14. These data reveal a pressing need for the use of a validated instrument to assess patient satisfaction with risk-reduction strategy. Previously, our group has published on clinical factors associated with risk-reduction strategy choice among women known to be BRCA mutation positive as well as all women who were tested for BRCA mutations at our institution15, 16. The information from these studies was utilized to design the current study.
The assessment of patient satisfaction with PS versus RRSO is an area which would provide necessary information to appropriately guide and counsel women at high risk for breast and ovarian cancer regarding risk reduction options. To our knowledge, no study has directly measured satisfaction with ovarian cancer risk reduction strategies using a validated instrument. The satisfaction with decision (SWD) scale addresses six key aspects of decision-making and has been validated to assess overall satisfaction with medical decisions17. Therefore, we surveyed a cohort of women at high risk for breast and ovarian cancer to determine level of satisfaction with risk reduction management strategy and identify factors associated with level of satisfaction.
Patients and Methods
Patients
Women at high risk for hereditary breast and ovarian cancer are referred to genetic counselors at The University of Texas M. D. Anderson Cancer Center (MDACC) that specialize in hereditary cancers unique to the female population. These women are identified based on established referral criteria from the Society of Gynecologic Oncologists18. If women choose to pursue genetic testing, they receive extensive pre- and post-test counseling. As part of a multi-departmental effort among members of the Departments of Gynecologic Oncology, Breast Medical Oncology and Behavioral Science, our group conducted a follow-up study to assess quality of life concerns and satisfaction with risk reduction strategy in women who previously underwent genetic testing for high risk of developing breast and ovarian cancer.
Approval for this study was obtained through the Institutional Review Board at our institution. Women who underwent testing for BRCA 1 or BRCA 2 mutations at our institution or were seen for genetic counseling for a known mutation from January 1997 through July 2005 were identified through the MDACC Tumor Registry and Genetics Database. We created a questionnaire packet which ascertained demographic and clinical information as well as quality of life and beliefs regarding issues pertinent to women at high risk for developing breast and ovarian cancer. These sections provided subjects with a variety of statements to describe their perceptions about screening, chemoprevention strategies, and risk-reducing surgery using Likert-based scales. Several validated instruments to address health and well-being, cancer-related anxiety, and satisfaction were also included. Additional demographic and clinical data were obtained from the electronic medical record and genetic counseling charts.
The questionnaire packet was mailed to potential participants. Non-responders received a follow up phone call one month after the initial mailing. A second mailing was performed at the six-month time point and was followed up by a final phone call one month after the second mailing. After one year, participants who did not return the questionnaire were classified as non-responders. Women who returned surveys received a $10 gift card to a book store for their participation. All participants provided implied written consent based on survey completion.
We report the data from women who chose between the risk reduction strategies of PS and RRSO. Women with prior diagnosis of ovarian cancer or who underwent oophorectomy for benign indications were excluded. Subjects who did not complete the SWD were ineligible, given this was our primary outcome measure.
Measures
The Cancer Worry Scale (CWS) was utilized to determine level of anxiety related to developing cancer19. This instrument consists of 4 statements evaluated on a Likert-type scale addressing frequency of cancer-related worry, impact of worry on mood and functioning, and overall level of cancer-related worry. Scores range from 1 to 16, with higher scores indicating higher level of worry19. The CWS was used to assess anxiety associated with development of both ovarian and breast cancer, given that RRSO is known to impact the risk of both cancer types.
We also included the Endocrine Subscale of the Functional Assessment of Cancer Therapy (FACT-ES), a tool validated to assess symptoms commonly experienced by women after natural, surgical, or medically-induced menopause20. This scale consists of 18 items which address menopausal and sexual symptoms, including hot flashes. Low scores indicate higher level of symptoms in a range from 0 to 7220.
Sexual function was measured using the Sexual Activity Questionnaire, a validated instrument that assesses relationship status, reasons for sexual inactivity (if applicable) and a 10-item scale that describes sexual functioning in terms of activity (habit), pleasure, and discomfort21. High scores for pleasure reflect high satisfaction, and high scores for discomfort indicate higher levels of dryness and pain21.
The modified Body Image Scale is a 4-item scale which includes questions related to body appearance and scarring22. It has been validated for use in patients with cancer who have undergone surgery that involves major alteration of body image. This includes loss of a body part or disfigurement that may occur with surgeries such as mastectomy22, colorectal surgery23, and hysterectomy24. Scores range from 0 to 16, where lower scores indicate lower levels of distress about body image22.
The Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire was developed to address distress after receipt of genetic testing results25. This validated scale includes a variety of questions which explore psychosocial issues which arise after genetic testing. For the purposes of this study, we examined the three subscales within the general scale which cover specific issues regarding distress, uncertainty, and positive experiences after genetic testing. The distress, uncertainty, and positive experiences subscales are scored from 0 – 30, 0 – 45, and 0 – 20, respectively. Of note, for the distress and uncertainty scales, higher scores represent a more negative impact of the genetic testing result. Conversely, in the positive experiences subscale, higher scores represent a positive experience after disclosure of results25.
Finally, patients without a diagnosis of ovarian cancer were asked to complete the SWD for their current ovarian cancer risk-reduction strategy, PS or RRSO. This validated scale consists of 6 questions addressing components of satisfaction and decision-making, and has a score range of 6 – 30. Higher scores indicate higher level of satisfaction with decision. The SWD underwent initial validation in a population of peri-menopausal women facing the decision of whether or not to take hormone replacement therapy17. This scale has been employed to measure satisfaction in patients receiving treatment for depression26 and prostate cancer27. The SWD has also been utilized to predict compliance with head and neck surgery28. In this study, the SWD was utilized to determine the overall patient satisfaction with risk-reduction strategy.
Statistical Analysis
The SWD score was compared between the PS and RRSO cohorts. In addition, analyses of those patients with low satisfaction scores were performed to determine the impact of demographics, clinical factors, or personal beliefs on satisfaction level. We also evaluated the association of level of satisfaction with the quality of life measures previously described.
A low satisfaction score was defined as a score in the lowest 10th percentile and high satisfaction was defined as a score in the remaining 90th percentile. These levels were chosen based on the median value of the SWD scale within our population. There is no known cutoff level for satisfaction based on existing literature incorporating the SWD scale. Group comparisons of categorical variables were evaluated with chi-square and Fisher’s Exact tests. Group comparisons of continuous variables were evaluated using t-tests and Mann-Whitney tests. Linear regression analyses was performed to determine the impact of key variables on satisfaction score. All analyses were performed utilizing SPSS 17.0 (Chicago, IL). A p-value less than 0.05 was considered statistically significant.
Results
Population
The questionnaire was mailed to 544 eligible women. Three hundred and thirteen (58%) responded within the study time frame of 12 months. Of those, 131 (42%) were excluded from the current study due to history of prior oophorectomy or incomplete SWD score, leaving 182 (58%) valid questionnaires for analysis. The group of patients excluded from analysis had a higher median age and proportion who were parous and menopausal. Otherwise, there were no significant differences between the patients included in the analysis and those excluded in their race, education level, insurance status, and marital status.
A comparison of the key demographic and clinical features between the two risk-reducing cohorts is presented in Table 2. Of note, subjects in the PS group were significantly younger than RRSO women (47.2 years vs. 50.1 years, p = 0.02) and less likely to be menopausal (48.3 vs. 64.9%, p = 0.05). In addition, patients who underwent RRSO for ovarian cancer risk reduction were significantly more likely to have a BRCA mutation (53.2% vs. 22.5%, p < 0.001) than those who underwent PS. Women who underwent RRSO did so a median of 25.2 months prior to completing our questionnaire packet. Women in the study population received genetic testing results a median of 21.2 months prior to completing the study packets.
Table 2.
Demographic and clinical characteristics of study population (N=182)
| Characteristic | PS n = 120 | RRSO n = 62 | p value |
|---|---|---|---|
| Median Age, (years) | 47.2 | 50.1 | 0.02 |
| Range | (22 – 85) | (40 – 76) | |
|
| |||
| Race, n (%) | |||
| White | 97 (80.8) | 55 (88.7) | 0.40 |
| Hispanic | 13 (10.8) | 4 (6.5) | |
| Asian | 7 (5.8) | 2 (3.2) | |
| Black | 3 (2.5) | 0 (0.0) | |
| Other | 0 (0.0) | 1 (1.6) | |
|
| |||
| Menopausal, n (%)* | 56 (48.3) | 37(64.9) | 0.04 |
|
| |||
| Married/Living with partner, n (%) | 96 (80.0) | 46 (74.2) | 0.37 |
|
| |||
| Educational Level, n (%) | |||
| Some High School | 3 (1.7) | 0 (0) | 0.56 |
| High School Grad/GED | 13 (7.6) | 5 (7.4) | |
| Some College/Tech School | 44 (25.6) | 14 (20.6) | |
| College Grad/Higher Degree | 112 (65.1) | 49 (72.1) | |
|
| |||
| Parous, n (%) | 89(74.2) | 46 (74.2) | 1.0 |
|
| |||
| Ashkenazi Jewish, n (%)** | 17 (14.5) | 11 (18.6) | 0.48 |
|
| |||
| BRCA 1, 2 Mutation, n (%) | 27 (22.5) | 33 (53.2) | <0.001 |
|
| |||
| Any Family History | |||
| Breast Ca, n (%) | 99 (82.5) | 55 (88.7) | 0.27 |
| Ovarian Ca, n (%) | 39 (32.5) | 24 (38.7) | 0.40 |
|
| |||
| Personal History | 0.64 | ||
| Breast Ca, n (%) | 89 (74.2) | 48 (77.4) | |
Data missing for 9 patients,
Data missing for 6 patients. Continuous variables compared with Mann-Whitney Test, Categorical variables were compared with Chi-Square and Fisher’s Exact tests.
Patient Satisfaction
Overall satisfaction levels in all women at high risk for breast and ovarian cancer were high in this study; with a median SWD score of 29 (range 14–30). Women who chose RRSO as their risk-reduction strategy were more satisfied when compared with women who chose PS (30.0 vs. 26.5, median SWD, p<.001). BRCA-positive women also demonstrated higher satisfaction levels regarding their decision compared to their BRCA-negative counterparts regardless of risk-reduction strategy (30 vs. 28, p=.01). Further comparison of the SWD scale between the PS and RRSO groups revealed that a higher number of women in the PS group were ambivalent in terms of each component of satisfaction with risk-reduction strategy (Table 3).
Table 3.
Ambivalence on Satisfaction With Decision (SWD) scale based on risk-reduction strategy
| Statement from SWD | Neither Agree Nor Disagree | p value* | |
|---|---|---|---|
| PS n = 120 | RRSO n = 62 | ||
| I am satisfied that I was adequately informed about the issues important to my decision, n (%) | 6 (5.0) | 4 (6.5) | 0.74 |
|
| |||
| The decision I made was the best decision possible for me personally, n (%) | 19 (15.8) | 1 (1.6) | 0.002 |
|
| |||
| I am satisfied that my decision was consistent with my personal values, n (%) | 17 (14.2) | 0 (0.0) | 0.001 |
|
| |||
| I expect to successfully carry out (or continue to carry out) the decision I made, n (%) | 19 (15.8) | 0 (0.0) | <0.001 |
|
| |||
| I am satisfied that this was my decision to make, n (%) | 11 (9.2) | 0 (0.0) | 0.02 |
|
| |||
| I am satisfied with my decision, n (%) | 14 (11.7) | 1 (1.6) | 0.02 |
Variables were compared with Chi-Square and Fisher’s Exact tests.
An analysis was performed to determine if any demographic, clinical, or personal factors were associated with lower satisfaction levels (SWD score less than the 10th percentile). There were no demographic or clinical features significantly associated with satisfaction in this study including race, parity, menopausal status, or marital status at the time of questionnaire completion (data not shown). After adjusting for age, parity, and risk reduction strategy, the only significant predictor of high level of satisfaction with decision was RRSO as the risk-reduction strategy (B=3.1; 95% CI 1.86, 4.33; p<.001).
In the questionnaire, patients were given an opportunity to express feelings and perceptions regarding their BRCA diagnoses and options for risk-reduction strategies. The complete list of statements provided is available in Table 4. Interestingly, low satisfaction scores were associated with the patient perception that the decision between RRSO and PS was difficult to make (Table 4).
Table 4.
Association of personal perceptions regarding risk-reduction with level of satisfaction with risk-reduction strategy.
| Statement | Low Satisfaction | High Satisfaction | p Value* |
|---|---|---|---|
| Agree, n (%) | Agree, n (%) | ||
| “It is hard for me to decide whether I should do ovarian cancer screening or have prophylactic (preventive) surgery to remove my ovaries.” (n=157) | 8 (61.5) | 25 (17.4) | 0.001 |
| “Having my ovaries removed is the only way to reduce my worry of developing breast cancer.” (n=137) | 2 (20.0) | 12 (9.4) | 0.27 |
| “The best way for me to lower my risk of getting breast cancer is to have prophylactic surgery to remove my ovaries.” (n=139) | 3 (30.0) | 51 (39.5) | 0.74 |
| “Prophylactic surgery to remove the ovaries is too drastic a measure to prevent cancer.” (n=153) | 0 (0.0) | 20 (14.4) | 0.22 |
| “I avoid having ovarian cancer screening because the procedures are painful.” (n=162) | 0 (0.0) | 2 (1.4) | 1.0 |
| “I am reluctant to undergo ovarian cancer screening because the procedures are embarrassing.” (n=169) | 0 (0.0) | 4 (2.7) | 1.0 |
| “It is difficult to get ovarian cancer screening because my insurance may not pay for the tests.” (n=146) | 0 (0.0) | 19 (14.8) | 0.13 |
| “Having ovarian cancer screening is hard for me because I worry about getting abnormal results.” (n=164) | 2 (11.1) | 24 (16.4) | 0.74 |
Low satisfaction defined as a SWD score in the lowest 10th percentile (21).
Subjects were given the option to omit questions, thus, participation number for each statement is given. Variables were compared with Chi-Square and Fisher’s Exact tests.
We also assessed the impact of anxiety about future risk of cancer on patient satisfaction with risk-reduction strategy. There was no association between level of satisfaction and degree of breast or ovarian cancer-related worry (Table 5). Based on analysis of the MICRA instrument, stress level after genetic test disclosure was not associated with low satisfaction. However, higher levels of uncertainty after genetic test result disclosure were associated with lower levels of satisfaction (p=0.02; Table 5).
Table 5.
Association of QOL instrument score with level of satisfaction with risk-reduction strategy.
| Median QOL Instrument Score | Low Satisfaction | High Satisfaction | p Value* |
|---|---|---|---|
|
| |||
| Ovarian Cancer Worry Score (n=175) | 6.0 | 6.0 | 0.10 |
|
| |||
| Breast Cancer Worry Score (n=175) | 8.0 | 7.5 | 0.93 |
|
| |||
| Functional Assessment of Cancer Therapy- Endocrine (n=181) | 60.0 | 59.0 | 0.71 |
|
| |||
| Sexual Activity Questionnaire | |||
| Pleasure (n=130) | 8.0 | 10.0 | 0.25 |
| Discomfort (n=127) | 3.5 | 3.0 | 0.44 |
| Habit (n=119) | 1.0 | 1.0 | 0.37 |
|
| |||
| Body Image Scale (n=144) | 8.0 | 4.0 | 0.05 |
|
| |||
| MICRA Scale | |||
| Distress (n=176) | 1.0 | 2.0 | 0.91 |
| Positive Experiences (n=175) | 7.0 | 6.0 | 0.68 |
| Uncertainty (n=173) | 16.5 | 12.0 | 0.02 |
Low satisfaction defined as a SWD score in the lowest 10th percentile (21).
Subjects were given the option to omit questions, thus, participation number for each instrument is given. Continuous variables compared with Mann-Whitney Test, Categorical variables were compared with Chi-Square and Fisher’s Exact tests.
Given the impact of sexual functioning and endocrine-related symptoms on quality of life in prior studies of women at high risk for breast and ovarian cancer13, 29–31, we assessed the association between satisfaction level and median score from the SAQ subscales, FACT-endocrine, and BIS (Table 5). None of the SAQ subscale scores were significantly associated with satisfaction level. In addition, patients with low SWD scores had similar FACT-endocrine scores when compared to those with high SWD scores. Patients with lower satisfaction levels did have a higher median score on the BIS, indicating higher levels of distress with respect to body image (8 vs. 4, p=.05).
Discussion
The main finding from our study was that women at high risk for breast and ovarian cancer were very satisfied with their choice of risk-reduction strategy. To date, a review of the literature reveals our study is the first to demonstrate this with a validated instrument to measure satisfaction. Interestingly, patients who chose RRSO demonstrated higher levels of satisfaction when compared to patients that chose PS. High satisfaction has also been demonstrated in several studies of women undergoing mastectomy for breast cancer risk reduction32.
Lower satisfaction levels in women who had PS compared to women who underwent RRSO may be partially due to difficulty with decision-making in regards to a high-risk management strategy. Certainly, RRSO is the more definitive option and allows no further room for ambivalence or conflict. As a surgical procedure, RRSO offers a permanent outcome, one that cannot be reversed. In contrast, women who undergo PS can theoretically still opt for RRSO at some point in the future. The possibility of being able to switch from PS to RRSO may introduce some level of uncertainty in women who chose PS, possibly contributing to less overall satisfaction in knowing that a woman has made the “correct choice”. Response shift, or the change in one’s internal evaluation of well-being, may be another reason for high satisfaction levels in women who chose RRSO. It makes sense intuitively that once a woman has undergone RRSO, her thinking would “recalibrate” to accept and validate her choice of risk-reducing strategy33.
Women in the low satisfaction group also reported higher levels of uncertainty after disclosure of genetic test results on the MICRA. The uncertainty subscale of the MICRA covers a broad range of topics including uncertainty about risk of cancer, impact of genetic test result on family, and frustration regarding uncertain guidelines for cancer risk reduction25. Patients in the PS group demonstrated conflicted feelings about their choice of risk-reduction strategy and lack of a definitive plan of action. The finding of higher levels of ambivalence on each component of the SWD scale among women who chose PS suggests that these women may still be considering their options for risk-reduction.
Furthermore, BRCA positive respondents had higher levels of satisfaction than respondents who were BRCA negative. If uncertainty is a cause for low satisfaction levels, the higher satisfaction seen among BRCA mutation carriers may be attributed to the clear set of guidelines for risk reduction provided to this population. Conversely, women with uninformative negative BRCA results are left without a concrete explanation for their high-risk status. This result is by no means a definitive negative, and women with this result are often left with no clear idea if they are free of risk or if they are high risk carriers of a mutation not yet discovered. Thus, they may choose PS as a risk-reduction strategy but experience uncertainty regarding their decision.
Quality of life assessment after choice of risk-reduction strategy has focused mainly on the sequelae of RRSO. In general, RRSO appears to positively impact cancer-related anxiety and overall perception of risk while negatively impacting sexual functioning and endocrine-related symptoms13, 29–31. Therefore, we theorized that higher satisfaction levels found in patients who chose RRSO might be related to decreased levels of cancer-related anxiety. Interestingly, this was not the case in our patient population. Furthermore, the adverse effects associated with RRSO, including endocrine-related symptoms and sexual dysfunction, were not significantly associated with level of satisfaction. Our data suggest that women who chose RRSO were willing to accept the trade-offs of increased likelihood of experiencing endocrine-related symptoms and sexual dysfunction with a decreased risk of developing ovarian cancer.
We also hypothesized that factors associated with regret after tubal sterilization would also be important in regret after surgical risk-reduction. Based on literature from the United States, young age is a key factor implicated in regret after sterilization34–36. Therefore, we thought that younger women who had not yet completed childbearing would have lower satisfaction levels with RRSO. This theory was not supported by our data, as the median age of women who underwent RRSO was older, indicating that patients completed childbearing prior to their surgery. In addition, after adjusting for age, parity and type of risk reduction strategy, only RRSO was associated with higher satisfaction levels.
Overall, there is a paucity of data addressing quality of life and satisfaction in this group of patients. A prospective study comparing the quality of life of 38 RRSO patients to 37 PS patients revealed decreased physical and sexual functioning at a one month time point. This difference was negligible at a six month time point37. The largest study comparing quality of life between these two risk reduction strategies found no difference in overall quality of life between RRSO and PS respondents at a non-specified time point. Despite reporting decreased sexual functioning and increased vasomotor symptoms, 86% of women in that study stated they would choose RRSO for risk reduction if given the choice again13. This led us to hypothesize that there were factors other than sexual functioning and vasomotor symptoms which impact satisfaction with decision of risk-reduction strategy.
In 2001, Swisher and colleagues reported on patient satisfaction and regret associated with the management strategy of 60 women at high risk for ovarian cancer14. The Swisher interview study and our study are the only two published studies comparing satisfaction between the two risk-reduction strategies. In their study, Swisher et al. found that 93% (28/30) of women who chose RRSO were satisfied compared to 90% (27/30) of women who chose PS for their risk-reduction strategy. However, this study also demonstrated that only 2 women (7%) in the RRSO group expressed regret about their decision while 15 (50%) women expressed regret regarding the decision to pursue PS14. Of note, there was no validated instrument used for the measurement of satisfaction. In the Swisher study, regret appeared to be related to inconsistent recommendations for screening. This correlates well with our finding that uncertainty after genetic test disclosure was associated with low levels of satisfaction with risk-reduction strategy.
The strengths of our study include the use of a validated instrument to measure satisfaction, large sample size, and an excellent response rate. In addition, we are fortunate to have an excellent genetic counseling department which provided consistent information to all patients regarding risk reduction options. However, our study is limited due to lack of baseline data regarding anxiety and baseline functioning. In addition, data collection was not conducted prospectively, and our data present the symptoms and feelings of patients at a single point in time. Despite these issues, our findings reveal a potential opportunity to intervene at the time a woman makes her decision between the risk-reduction strategies by providing the information and support necessary to insure patient satisfaction with choice of risk-reduction strategy.
In conclusion, our study demonstrates that there exists a subset of women who are unsatisfied with their decision to pursue PS for risk reduction. Prospective studies and focus groups will be essential to determine the optimal method to improve patient satisfaction levels after risk-reduction management decision.
Table 1.
Society of Gynecologic Oncologists criteria for BRCA mutation testing18
| Personal history of both breast and ovarian/primary peritoneal/fallopian tube cancer |
| Women with ovarian cancer and a close relative (first, second, or third degree relative) with breast cancer at ≤50 years, or ovarian cancer at any age |
| Women of Ashkenazi Jewish ancestry with ovarian cancer at any age |
| Women with breast or ovarian cancer at any age and ≥2 close relatives with breast cancer at any age, particularly if at least 1 breast cancer ≤50 years |
Acknowledgments
Funding: NIH T32 Training Grant 5T32CA10164202 (SW, RL)
Footnotes
This research was presented at the 44th Annual Meeting of the American Society for Clinical Oncology, June 1–5, 2007, Chicago, IL.
References
- 1.Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009;59(4):225–49. doi: 10.3322/caac.20006. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19474385. [DOI] [PubMed] [Google Scholar]
- 2.Risch HA, McLaughlin JR, Cole DE, Rosen B, Bradley L, Kwan E, et al. Prevalence and penetrance of germline BRCA1 and BRCA2 mutations in a population series of 649 women with ovarian cancer. Am J Hum Genet. 2001;68(3):700–10. doi: 10.1086/318787. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11179017. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Pal T, Permuth-Wey J, Betts JA, Krischer JP, Fiorica J, Arango H, et al. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer. 2005;104(12):2807–16. doi: 10.1002/cncr.21536. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16284991. [DOI] [PubMed] [Google Scholar]
- 4.Lux MP, Fasching PA, Beckmann MW. Hereditary breast and ovarian cancer: review and future perspectives. J Mol Med. 2006;84(1):16–28. doi: 10.1007/s00109-005-0696-7. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16283147. [DOI] [PubMed] [Google Scholar]
- 5.Ries LAG, Harkins D, Krapcho M, Mariotto A, Miller BA, Feuer EG, et al. SEER Cancer Statistics Review, 1975–2003. Vol. 2008. Bethesda, MD: National Cancer Institute; 2006. [Google Scholar]
- 6.Boyd J. Specific keynote: hereditary ovarian cancer: what we know. Gynecol Oncol. 2003;88(1 Pt 2):S8–10. doi: 10.1006/gyno.2002.6674. discussion S11–3. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12586076. [DOI] [PubMed] [Google Scholar]
- 7.Stratton JF, Pharoah P, Smith SK, Easton D, Ponder BA. A systematic review and meta-analysis of family history and risk of ovarian cancer. Br J Obstet Gynaecol. 1998;105(5):493–9. doi: 10.1111/j.1471-0528.1998.tb10148.x. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=9637117. [DOI] [PubMed] [Google Scholar]
- 8.Bell R, Petticrew M, Sheldon T. The performance of screening tests for ovarian cancer: results of a systematic review. Br J Obstet Gynaecol. 1998;105(11):1136–47. doi: 10.1111/j.1471-0528.1998.tb09966.x. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=9853761. [DOI] [PubMed] [Google Scholar]
- 9.Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van’t Veer L, Garber JE, et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002;346(21):1616–22. doi: 10.1056/NEJMoa012158. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12023993. [DOI] [PubMed] [Google Scholar]
- 10.Kauff ND, Satagopan JM, Robson ME, Scheuer L, Hensley M, Hudis CA, et al. Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002;346(21):1609–15. doi: 10.1056/NEJMoa020119. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12023992. [DOI] [PubMed] [Google Scholar]
- 11.Finch A, Beiner M, Lubinski J, Lynch HT, Moller P, Rosen B, et al. Salpingo-oophorectomy and the risk of ovarian, fallopian tube, and peritoneal cancers in women with a BRCA1 or BRCA2 Mutation. Jama. 2006;296(2):185–92. doi: 10.1001/jama.296.2.185. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16835424. [DOI] [PubMed] [Google Scholar]
- 12.Rebbeck TR, Kauff ND, Domchek SM. Meta-analysis of risk reduction estimates associated with risk-reducing salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers. J Natl Cancer Inst. 2009;101(2):80–7. doi: 10.1093/jnci/djn442. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19141781. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Madalinska JB, Hollenstein J, Bleiker E, van Beurden M, Valdimarsdottir HB, Massuger LF, et al. Quality-of-life effects of prophylactic salpingo-oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. J Clin Oncol. 2005;23(28):6890–8. doi: 10.1200/JCO.2005.02.626. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16129845. [DOI] [PubMed] [Google Scholar]
- 14.Swisher EM, Babb S, Whelan A, Mutch DG, Rader JS. Prophylactic oophorectomy and ovarian cancer surveillance. Patient perceptions and satisfaction. J Reprod Med. 2001;46(2):87–94. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11255821. [PubMed] [Google Scholar]
- 15.Schmeler KM, Sun CC, Bodurka DC, White KG, Soliman PT, Uyei AR, et al. Prophylactic bilateral salpingo-oophorectomy compared with surveillance in women with BRCA mutations. Obstet Gynecol. 2006;108(3 Pt 1):515–20. doi: 10.1097/01.AOG.0000228959.30577.13. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16946209. [DOI] [PubMed] [Google Scholar]
- 16.Uyei A, Peterson SK, Erlichman J, Broglio K, Yekell S, Schmeler K, et al. Association between clinical characteristics and risk-reduction interventions in women who underwent BRCA1 and BRCA2 testing: a single-institution study. Cancer. 2006;107(12):2745–51. doi: 10.1002/cncr.22352. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17109443. [DOI] [PubMed] [Google Scholar]
- 17.Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, et al. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996;16(1):58–64. doi: 10.1177/0272989X9601600114. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=8717600. [DOI] [PubMed] [Google Scholar]
- 18.Lancaster JM, Powell CB, Kauff ND, Cass I, Chen LM, Lu KH, et al. Society of Gynecologic Oncologists Education Committee statement on risk assessment for inherited gynecologic cancer predispositions. Gynecol Oncol. 2007;107(2):159–62. doi: 10.1016/j.ygyno.2007.09.031. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17950381. [DOI] [PubMed] [Google Scholar]
- 19.Lerman C, Daly M, Masny A, Balshem A. Attitudes about genetic testing for breast-ovarian cancer susceptibility. J Clin Oncol. 1994;12(4):843–50. doi: 10.1200/JCO.1994.12.4.843. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=8151327. [DOI] [PubMed] [Google Scholar]
- 20.Fallowfield LJ, Leaity SK, Howell A, Benson S, Cella D. Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B. Breast Cancer Res Treat. 1999;55(2):189–99. doi: 10.1023/a:1006263818115. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10481946. [DOI] [PubMed] [Google Scholar]
- 21.Thirlaway K, Fallowfield L, Cuzick J. The Sexual Activity Questionnaire: a measure of women’s sexual functioning. Qual Life Res. 1996;5(1):81–90. doi: 10.1007/BF00435972. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=8901370. [DOI] [PubMed] [Google Scholar]
- 22.Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001;37(2):189–97. doi: 10.1016/s0959-8049(00)00353-1. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11166145. [DOI] [PubMed] [Google Scholar]
- 23.da Silva GM, Hull T, Roberts PL, Ruiz DE, Wexner SD, Weiss EG, et al. The effect of colorectal surgery in female sexual function, body image, self-esteem and general health: a prospective study. Ann Surg. 2008;248(2):266–72. doi: 10.1097/SLA.0b013e3181820cf4. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18650637. [DOI] [PubMed] [Google Scholar]
- 24.Gorlero F, Lijoi D, Biamonti M, Lorenzi P, Pulle A, Dellacasa I, et al. Hysterectomy and women satisfaction: total versus subtotal technique. Arch Gynecol Obstet. 2008;278(5):405–10. doi: 10.1007/s00404-008-0615-6. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18338177. [DOI] [PubMed] [Google Scholar]
- 25.Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, et al. A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol. 2002;21(6):564–72. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12433008. [PubMed] [Google Scholar]
- 26.Wills CE, Holmes-Rovner M. Preliminary validation of the Satisfaction With Decision scale with depressed primary care patients. Health Expect. 2003;6(2):149–59. doi: 10.1046/j.1369-6513.2003.00220.x. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12752743. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Berry DL, Ellis WJ, Russell KJ, Blasko JC, Bush N, Blumenstein B, et al. Factors that predict treatment choice and satisfaction with the decision in men with localized prostate cancer. Clin Genitourin Cancer. 2006;5(3):219–26. doi: 10.3816/CGC.2006.n.040. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17239276. [DOI] [PubMed] [Google Scholar]
- 28.Parhiscar A, Rosenfeld RM. Can patient satisfaction with decisions predict compliance with surgery? Otolaryngol Head Neck Surg. 2002;126(4):365–70. doi: 10.1067/mhn.2002.123445. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11997774. [DOI] [PubMed] [Google Scholar]
- 29.Elit L, Esplen MJ, Butler K, Narod S. Quality of life and psychosexual adjustment after prophylactic oophorectomy for a family history of ovarian cancer. Fam Cancer. 2001;1(3–4):149–56. doi: 10.1023/a:1021119405814. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=14574171. [DOI] [PubMed] [Google Scholar]
- 30.Robson M, Hensley M, Barakat R, Brown C, Chi D, Poynor E, et al. Quality of life in women at risk for ovarian cancer who have undergone risk-reducing oophorectomy. Gynecol Oncol. 2003;89(2):281–7. doi: 10.1016/s0090-8258(03)00072-6. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12713992. [DOI] [PubMed] [Google Scholar]
- 31.Tiller K, Meiser B, Butow P, Clifton M, Thewes B, Friedlander M, et al. Psychological impact of prophylactic oophorectomy in women at increased risk of developing ovarian cancer: a prospective study. Gynecol Oncol. 2002;86(2):212–9. doi: 10.1006/gyno.2002.6737. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12144830. [DOI] [PubMed] [Google Scholar]
- 32.Lostumbo L, Carbine N, Wallace J, Ezzo J. Prophylactic mastectomy for the prevention of breast cancer. Cochrane Database Syst Rev. 2004;(4):CD002748. doi: 10.1002/14651858.CD002748.pub2. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=15495033. [DOI] [PubMed]
- 33.Barclay-Goddard R, Epstein JD, Mayo NE. Response shift: a brief overview and proposed research priorities. Qual Life Res. 2009;18(3):335–46. doi: 10.1007/s11136-009-9450-x. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19241143. [DOI] [PubMed] [Google Scholar]
- 34.Peterson HB. Sterilization. Obstet Gynecol. 2008;111(1):189–203. doi: 10.1097/01.AOG.0000298621.98372.62. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18165410. [DOI] [PubMed] [Google Scholar]
- 35.Moseman CP, Robinson RD, Bates GW, Jr, Propst AM. Identifying women who will request sterilization reversal in a military population. Contraception. 2006;73(5):512–5. doi: 10.1016/j.contraception.2005.11.005. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16627036. [DOI] [PubMed] [Google Scholar]
- 36.Curtis KM, Mohllajee AP, Peterson HB. Regret following female sterilization at a young age: a systematic review. Contraception. 2006;73(2):205–10. doi: 10.1016/j.contraception.2005.08.006. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16413851. [DOI] [PubMed] [Google Scholar]
- 37.Fang CY, Cherry C, Devarajan K, Li T, Malick J, Daly MB. A prospective study of quality of life among women undergoing risk-reducing salpingo-oophorectomy versus gynecologic screening for ovarian cancer. Gynecol Oncol. 2009;112(3):594–600. doi: 10.1016/j.ygyno.2008.11.039. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19141360. [DOI] [PMC free article] [PubMed] [Google Scholar]
