ABSTRACT
BACKGROUND: Up to 85% of breast cancer patients report sexual health concerns, but their concerns are not adequately addressed by providers. Sexual dysfunction among breast cancer patients remains understudied. We aimed to investigate the impact of breast-conserving therapy (BCT) and postmastectomy breast reconstruction (PMBR) on the sexual health of breast cancer patients and frequency of sexual medicine consultation in postoperative care. METHODS: We conducted a retrospective analysis of patients who underwent BCT or PMBR and completed the Sexual Well-being of the BREAST-Q BCT and Reconstruction modules from January 2010 to October 2022. We compared Sexual Well-being scores between BCT and PMBR patients overtime up to 5-years postoperatively, delineated associated demographic and clinical factors with Sexual Well-being, and evaluated the frequency of sexual medicine consultations. RESULTS: Of 15,857 patients, 8,510 (53.7%) underwent BCT and 7,347 (46.3%) underwent PMBR. PMBR patients had significantly lower Sexual Well-being scores than BCT patients from preoperative to 5-year postoperative. Regression analyses showed that PMBR patients scored 7.6 points lower at 1-year than BCT patients. Separated marital status, higher body mass index, cardiovascular disease, hyperlipidemia, psychiatric diagnosis, and neoadjuvant chemotherapy were associated with significantly lower Sexual Well-being. 299 (3.5%) of BCT and 400 (5.4%) of PMBR patients received sexual medicine consultations. CONCLUSION: Sexual health concerns must be considered in breast cancer care, particularly among patients who undergo PMBR. Although many patients experience sexual dysfunction, most do not receive a sexual medicine consultation, suggesting an opportunity for providers to improve breast cancer patients' sexual health.
ABSTRACT
BACKGROUND: Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns. AIM: The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo. METHODS: Participants were part of NRG Oncology's NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical trial evaluating bupropion (150 vs 300 mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates. OUTCOMES: The primary outcome of NRG Oncology's NRG-CC004 (NCT03180294) randomized phase II dose-finding trial was change from baseline to 9 weeks on the FSFI desire subscale score. Similar to the parent study, the primary outcome for this ancillary data study was the FSFI desire subscale score at 5 and 9 weeks. RESULTS: Overall, 230 participants completed the FSFI at baseline and 189 at 9 weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho = 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain.The impact of various covariates on the FSFI score for desire at 9 weeks demonstrated that participants of non-White race (odds ratio [OR], 0.42; 95% CI, 0.21-0.81; P = .010), with a high lubrication score (OR, 0.36; 95% CI, 0.21-0.61; P = .0002), with a high pain score (less pain) (OR, 0.50; 95% CI, 0.29-0.87; P = .014), or with prior pelvic surgery (OR, 0.38; 95% CI, 0.23-0.63; P = .0002) had lower odds of having low desire. CLINICAL IMPLICATIONS: Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention. STRENGTHS AND LIMITATIONS: This secondary analysis was not powered to examine all variables. CONCLUSION: Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire.
Subject(s)
Breast Neoplasms , Bupropion , Cancer Survivors , Genital Neoplasms, Female , Libido , Humans , Female , Bupropion/therapeutic use , Cancer Survivors/psychology , Middle Aged , Genital Neoplasms, Female/drug therapy , Genital Neoplasms, Female/complications , Breast Neoplasms/drug therapy , Breast Neoplasms/complications , Libido/drug effects , Adult , Double-Blind Method , Sexual Dysfunction, Physiological/drug therapy , AgedABSTRACT
PURPOSE: Sexual health concerns are common in breast cancer surgery but often overlooked. Yet, breast cancer patients want more sexual health information from their providers. We aimed to share ways for providers to address sexual health concerns with their breast cancer patients at different stages of the treatment process. METHODS: Experts in breast cancer treatments, surgeries, and sexual health at Memorial Sloan Kettering Cancer Center assembled to review the literature and to develop the recommendations. RESULTS: Providers should provide sexual health information for their breast cancer patients throughout the continuum of care. Conversations should be initiated by the providers and can be brief and informative. Whenever appropriate, patients should be referred to Sexual Medicine experts and/or psychosocial support. There are various recommendations and tools that can be utilized at diagnosis, endocrine and chemotherapy, and breast surgery to identify patients with sexual health concerns and to improve their sexual functioning. CONCLUSION: In this paper, we sought to provide providers with some insights, suggestions, and tools to address sexual health concerns. We encourage healthcare providers to initiate the conversation throughout the continuum of care beginning as early as diagnosis and refer patients to additional services if available.
Subject(s)
Breast Neoplasms , Sexual Health , Female , Humans , Breast Neoplasms/therapy , Breast Neoplasms/psychology , Breast Neoplasms/surgery , Sexual Dysfunction, Physiological/etiology , Sexual Dysfunction, Physiological/therapyABSTRACT
PURPOSE: Patients recovering from ambulatory cancer surgery at home may find it difficult to determine whether their postoperative symptoms are normal or potentially serious. We developed the Recovery Tracker to help patients navigate such issues. The Recovery Tracker is a 10-day, web-based electronic survey that monitors symptoms daily and provides feedback as to whether reported symptoms are expected or require follow-up. We sought to examine patient perceptions using this tool. METHODS: Semistructured interviews were conducted from August 2017 to September 2019 with a convenience sample of patients from a larger randomized controlled trial of the Recovery Tracker. Patients undergoing surgery at an ambulatory cancer center dedicated to the surgical treatment of breast, gynecologic, urologic, head, and neck cancers and benign tumors were included. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software. Recruitment was conducted iteratively until thematic saturation. RESULTS: Forty-three patients were interviewed. Interview responses were organized into five main themes: (1) The Recovery Tracker led to more seamless communication with the care team; (2) symptoms not expected or not listed on the Recovery Tracker caused stress; (3) the Recovery Tracker was perceived as an extension of care, prompting reflection about symptoms and recovery; (4) Enhanced Feedback provided reassurance and helped set expectations; and (5) the Recovery Tracker was easy to use. CONCLUSION: The patient experience of electronic symptom monitoring and feedback is congruent with the aims of such monitoring and feedback. Further qualitative research is required in more diverse populations.
Subject(s)
Neoplasms , Humans , Female , Qualitative Research , Surveys and Questionnaires , Patients , Patient Outcome AssessmentABSTRACT
PURPOSE: Cancer impacts caregivers as well as patients. Ambulatory oncology surgeries requiring a short hospital stay place additional responsibility on informal caregivers as they help patients navigate their post-operative recovery at home, and determine if symptoms are expected or emergent. Our objective was to explore the experience of informal caregivers during patients' ambulatory cancer surgery and then recovery at home with remote monitoring of symptoms via web-based patient-reported outcomes questionnaire ("Recovery Tracker"). METHODS: Semi-structured interviews were conducted with caregivers from a larger sample participating in a randomized trial of the Recovery Tracker. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software (QSR International Inc.). Recruitment was conducted iteratively to ensure a heterogenous sample and thematic saturation. RESULTS: Twenty-three semi-structured interviews were conducted. Four main themes emerged: (1) Predictability reduced stress among caregivers; (2) Unexpected events caused stress for caregivers; (3) The importance of a caregiver being present during the recovery process; and (4) Caregiver involvement in remote monitoring of symptoms was minimal. CONCLUSION: Caregivers report not being overly burdened by the ambulatory surgery process, but they are very sensitive to any deviations from what they expected to happen. Further research and clinical practice on caregivers in the ambulatory setting should focus on how to set expectations and avoid unexpected events.
Subject(s)
Caregiver Burden , Neoplasms , Ambulatory Surgical Procedures , Caregivers , Humans , Neoplasms/surgery , Qualitative Research , Surveys and QuestionnairesABSTRACT
PURPOSE: To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data. MATERIALS AND METHODS: The GST was developed on the basis of a comprehensive review of the literature, multidisciplinary expert opinion, and feedback from women with a history of gynecologic cancer. It is composed of 17 questions addressing six main categories-gynecologic health (abnormal bleeding/pain), lymphedema, vaginal/vulvar dryness, sexual health, menopause (hot flushes/sleep difficulties), and bowel/urinary issues. An electronic version using the Memorial Sloan Kettering Cancer Center Engage platform was piloted in two clinics for patients with endometrial or cervical cancer. Health information was generated into clinical summaries and identified concerns for actionable response. Associations of symptom and survey time point were assessed by longitudinal models using generalized estimating equations. RESULTS: From January 1, 2019, to February 29, 2020, 3,357 GST assessments were assigned to 1,405 patients, with a 71% completion rate (90% within 5 minutes). Sixty-eight percent were performed at home via a patient portal, 32% at follow-ups using a clinic iPad. The most common symptoms were bowel problems, swelling/fluid, pain during examination, vaginal or vulvar dryness, and vaginal bleeding. Implementation challenges included improving patient compliance and ensuring that reports were reviewed by all clinical teams. We developed screening e-mails detailing patients whose assessments were due, planned training sessions for multidisciplinary teams, and incorporated feedback on methods for reviewing symptoms reports. CONCLUSION: The GST demonstrated feasibility, a high completion rate, and minimal time commitment. It was an effective electronic reporting mechanism for patients, enabling the medical team to develop specific strategies for alleviating bothersome symptoms during follow-up.
Subject(s)
Genital Neoplasms, Female , Uterine Cervical Neoplasms , Female , Genital Neoplasms, Female/diagnosis , Genital Neoplasms, Female/therapy , Humans , Pain , Surveys and Questionnaires , SurvivorshipABSTRACT
Exposure to images of idealized bodies in the media has been shown to increase body dissatisfaction among women. One of the mechanisms through which exposure influences body dissatisfaction is appearance-based comparison with the people in the images. The present study tested the hypothesis that individuals low in self-concept clarity (i.e., individuals who lack a clear sense of their own identity) would be more likely to compare themselves to images of thin models, and would consequently experience greater body dissatisfaction. White female participants (N = 489) were exposed to either images featuring idealized bodies or neutral control images, and then indicated the extent to which they compared their appearance to that of the targets and reported their level of body dissatisfaction. A moderated-mediation model showed that the effect of exposure condition on body dissatisfaction via appearance comparison to the targets depended on the participant's level of self-concept clarity. Those with lower self-concept clarity engaged in greater comparison when exposed to idealized images relative to control images, leading to greater post-exposure body dissatisfaction. These findings suggest that low self-concept clarity might increase vulnerability to the negative effects of exposure to idealized media images.
Subject(s)
Body Dissatisfaction , Social Media , Body Image/psychology , Female , Humans , Personal Satisfaction , Self Concept , Social ComparisonABSTRACT
PURPOSE: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities. METHODS: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test. RESULTS: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups. CONCLUSION: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.
Subject(s)
Breast Neoplasms/therapy , Bupropion/administration & dosage , Cancer Survivors/psychology , Dopamine Uptake Inhibitors/administration & dosage , Genital Neoplasms, Female/therapy , Sexual Behavior/drug effects , Sexual Dysfunctions, Psychological/drug therapy , Adult , Aged , Bupropion/adverse effects , Delayed-Action Preparations , Dopamine Uptake Inhibitors/adverse effects , Double-Blind Method , Female , Humans , Middle Aged , Patient Reported Outcome Measures , Patient Satisfaction , Postmenopause , Sexual Dysfunctions, Psychological/diagnosis , Sexual Dysfunctions, Psychological/psychology , Time Factors , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Only 8-23% of advanced epithelial ovarian cancer patients survive for 10 years or longer. Given the need for targeted interventions to improve survival, we interviewed this relatively rare survivor population to gain personalized insights into the reasons for their survival. The aim of this study was to characterize subjective attributions of survival and specific coping mechanisms long-term survivors of ovarian cancer. METHODS: Twenty-two semi-structured, qualitative interviews assessing survival attributions and coping strategies were conducted from April to November 2014. Data were analyzed in a multistep process using ATLAS.ti.8: codes were identified during review of the transcripts and refined with literature review; the frequency of codes and code co-occurrence was calculated, and codes were grouped into themes. Resulting themes were checked by a national leader of an ovarian cancer advocacy organization and compared against available literature. RESULTS: Thematic analysis found that participants credited their long-term survival to a variety of factors including medical, social, religious/spiritual, and lifestyle/personal characteristics. Some participants rejected these same attributions, concluding that the reason for survival was due to luck or unknowable. Several of Carver et al.'s theoretical dimensions of coping were evident in our sample: planning, positive reinterpretation, social support, religion and acceptance whereas three relatively new strategies were uncovered: conserving emotional energy, value-based activity coping, and self-care. CONCLUSIONS: Long-term survivors' perspectives were largely consistent with those of newly diagnosed ovarian cancer patients and ovarian cancer survivors of shorter duration. However, the long-term survivors were also willing to reject conventional attributions for survival and recognized the importance of disciplined self-preservational coping strategies.
Subject(s)
Cancer Survivors , Ovarian Neoplasms , Adaptation, Psychological , Female , Humans , Qualitative Research , SurvivorsABSTRACT
BACKGROUND: Tools for diagnosing sexual dysfunction and for tracking outcomes of interest include clinician interviews, physical exam, and patient self-report. Limited work has described relationships among these three sources of information regarding female sexual dysfunction and vulvovaginal health. AIM: We describe correlations among data collected from clinician interviews, clinical gynecological examination, and patient self-report. METHODS: Data are from a single-site, single-arm, prospective trial in 100 postmenopausal patients with a history of breast or endometrial cancer who sought treatment for vulvovaginal symptoms. The trial collected a standardized clinical gynecologic exam, clinician-reported outcome (ClinRO) measures of vulvovaginal dryness and pain, and patient-reported outcome (PRO) measures of sexual function, including PROMIS Sexual Function and Satisfaction (SexFS) lubrication, vaginal discomfort, labial discomfort, and clitoral discomfort and Female Sexual Function Index (FSFI) lubrication and pain. We examined polyserial correlations between measures with bootstrapped 95% confidence intervals from the baseline and 12-14-week timepoints. RESULTS: All of the relationships between the ClinRO variables and the PRO variables were in the expected direction (ie, positive), but the strength of the relationships varied substantially. At 12-14 weeks, there were medium-to-large correlations between ClinRO vaginal dryness and SexFS Lubrication (0.64), ClinRO vulvar dryness and SexFS Lubrication (0.46), ClinRO vulvar discomfort and SexFS Labial Discomfort (0.70), and ClinRO vulvar discomfort and SexFS Clitoral Discomfort (0.43). With one exception, the correlations between the exam variables and the corresponding PRO scores were small (range 0.01-0.27). STRENGTHS & LIMITATIONS: Our study included a comprehensive, standardized gynecologic exam designed specifically to evaluate sexual dysfunction as well as established PRO measures with significant evidence for validity. A limitation of our findings is that the sample size was relatively small, and our sample was restricted to women who received cancer treatments known to have dramatic effects on vulvovaginal tissue quality. CONCLUSION: Patient- and clinician-reported vulvovaginal dryness and discomfort were moderately correlated with each other but not with clinical gynecologic exam findings. Understanding the relationships among these different types of data highlights the distinct contributions of each to understand vulvovaginal tissue quality and patient sexual function after cancer. Flynn KE, Lin L, Carter J, et al. Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer. J Sex Med 2021;18:1768-1774.
Subject(s)
Neoplasms , Sexual Dysfunction, Physiological , Vulvodynia , Female , Humans , Patient Reported Outcome Measures , Prospective Studies , Self Report , Sexual Dysfunction, Physiological/diagnosis , Sexual Dysfunction, Physiological/etiologyABSTRACT
OBJECTIVE: We implemented routine daily electronic monitoring of patient-reported outcomes (PROs) for 10âdays after discharge after ambulatory cancer surgery, with alerts to clinical staff for worrying symptoms. We sought to determine whether enhancing this monitoring by adding immediate automated normative feedback to patients regarding expected symptoms would further improve the patient experience. SUMMARY OF BACKGROUND DATA: PRO monitoring reduces symptom severity in cancer patients. In ambulatory cancer surgery, it reduces potentially avoidable urgent care center (UCC) visits, defined as those UCC visits without readmission. METHODS: Patients undergoing ambulatory cancer surgery (n = 2624) were randomized to receive standard PRO monitoring or enhanced feedback. The primary study outcome was UCC visits without readmission within 30âdays; secondary outcomes included patient anxiety and nursing utilization. RESULTS: There was no significant difference in the risk of a potentially avoidable UCC visit [1.0% higher in enhanced feedback, 95% confidence interval (CI) -0.2-3.1%; P = 0.12]. There were similarly no significant differences in UCC visits with readmission or readmission overall (P = 0.4 for both). Patients randomized to enhanced feedback demonstrated a quicker reduction in anxiety (P < 0.001) and required 14% (95% CI 8-19%; P < 0.001) and 10% (95% CI 5-16%, P < 0.001) fewer nursing calls over 10 and 30âdays postoperatively. CONCLUSIONS: Providing patients with feedback about symptom severity during recovery from ambulatory cancer surgery reduces anxiety and nursing workload without affecting UCC visits or readmissions. These results support wider incorporation of normative feedback in systems for routine PRO monitoring.
Subject(s)
Ambulatory Surgical Procedures , Monitoring, Ambulatory/instrumentation , Neoplasms/surgery , Symptom Flare Up , Ambulatory Care Facilities/statistics & numerical data , Female , Humans , Male , Middle AgedABSTRACT
PURPOSE: To assess the feasibility and efficacy of a non-hormonal hyaluronic acid (HLA) vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in postmenopausal women with a history of hormone receptor-positive (HR+) cancer. METHODS: For this single-arm, prospective longitudinal trial, we identified disease-free patients with a history of HR+ breast cancer treated with aromatase inhibitors or HR+ endometrial cancer treated with surgery and postoperative radiation. Participants used HLA daily for the first 2 weeks, and then 3×/week until weeks 12-14; dosage was then increased to 5×/week for non-responders. Vulvovaginal symptoms and pH were assessed at 4 time points (baseline [T1], 4-6 weeks [T2], 12-14 weeks [T3], 22-24 weeks [T4]) with clinical evaluation, the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Female Sexual Function Index (FSFI), and Menopausal Symptom Checklist (MSCL). RESULTS: Of 101 patients, mean age was 55 years (range, 31-78), 68% (n = 69) were partnered, and 60% (n = 61) were sexually active. In linear mixed models, VAS/VuAS scores significantly improved at all assessment points (all p < 0.001). MSCL scores similarly improved (all p < 0.001). FSFI scores significantly improved from T1 to T2 (p < 0.03), T3 (p < 0.001), and T4 (p < 0.001). Severe vaginal pH (> 6.5) decreased from 26% at T1 to 19% at T4 (p = 0.18). CONCLUSIONS: HLA moisturization improved vulvovaginal health/sexual function of cancer survivors. While HLA administration 1-2×/week is recommended for women in natural menopause, a 3-5×/week schedule appears to be more effective for symptom relief in cancer survivors.
Subject(s)
Aromatase Inhibitors/therapeutic use , Cancer Survivors , Hyaluronic Acid/therapeutic use , Vagina/pathology , Vaginal Diseases/drug therapy , Vulva/pathology , Adult , Aged , Atrophy , Breast Neoplasms/pathology , Breast Neoplasms/therapy , Endometrial Neoplasms/pathology , Endometrial Neoplasms/therapy , Female , Humans , Longitudinal Studies , Middle Aged , Postmenopause/physiology , Prospective Studies , Vaginal Creams, Foams, and Jellies/therapeutic useABSTRACT
OBJECTIVE: To assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244. METHODS: The prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14 days before surgery), and at 6, 12, 18, and 24 months after surgery. Assessments of LLE symptoms and disability were completed at the time of lower limb volume measurement. A linear mixed model was applied to examine the association of PROs/QOL with a Gynecologic Cancer Lymphedema Questionnaire (GCLQ) total score incremental change ≥4 (indicative of increased LLE symptoms) from baseline, a formal diagnosis of LLE (per the GCLQ), and limb volume change (LVC) ≥10%. RESULTS: In 768 evaluable patients, those with a GCLQ score change ≥4 from baseline had significantly worse QOL (p < 0.001), body image (p < 0.001), sexual and vaginal function (p < 0.001), limb function (p < 0.001), and cancer distress (p < 0.001). There were no significant differences in sexual activity rates between those with and without LLE symptoms. CONCLUSIONS: LLE is significantly detrimental to QOL, daily function, and body image. Clinical intervention trials to prevent and manage this chronic condition after gynecologic cancer surgery are needed.
Subject(s)
Genital Neoplasms, Female/surgery , Lymphedema/physiopathology , Lymphedema/psychology , Adult , Aged , Aged, 80 and over , Female , Humans , Leg/pathology , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/physiopathology , Postoperative Complications/psychology , Prospective Studies , Quality of LifeABSTRACT
Practice changing standardization of lower extremity lymphedema quantitative measurements with integrated patient reported outcomes will likely refine and redefine the optimal risk-reduction strategies to diminish the devastating limb-related dysfunction and morbidity associated with treatment of gynecologic cancers. The National Cancer Institute (NCI), Division of Cancer Prevention brought together a diverse group of cancer treatment, therapy and patient reported outcomes experts to discuss the current state-of-the-science in lymphedema evaluation with the potential goal of incorporating new strategies for optimal evaluation of lymphedema in future developing gynecologic clinical trials.
Subject(s)
Anthropometry/methods , Genital Neoplasms, Female/therapy , Lower Extremity/pathology , Lymphedema/diagnosis , Patient Reported Outcome Measures , Chemotherapy, Adjuvant/adverse effects , Dielectric Spectroscopy/methods , Dielectric Spectroscopy/standards , Female , Genital Neoplasms, Female/complications , Gynecologic Surgical Procedures/adverse effects , Humans , Lymph Node Excision/adverse effects , Lymphedema/etiology , Lymphedema/pathology , Lymphedema/therapy , Organ Size , Radiotherapy, Adjuvant/adverse effects , Risk Factors , Sentinel Lymph Node Biopsy/adverse effects , Treatment OutcomeABSTRACT
OBJECTIVE: Ovarian suppression is recommended to complement endocrine therapy in premenopausal women with breast cancer and high-risk features. It can be achieved by either medical ovarian suppression or therapeutic bilateral salpingo-oophorectomy. Our objective was to evaluate characteristics of patients with stage I-III hormone receptor positive primary breast cancer who underwent bilateral salpingo-oophorectomy at our institution. MATERIALS AND METHODS: Premenopausal women with stage I-III hormone receptor positive primary breast cancer diagnosed between January 2010 and December 2014 were identified from a database. Patients with confirmed BRCA1/2 mutations were excluded. Distribution of characteristics between treatment groups was assessed using χ2 test and univariate logistic regression. A multivariate model was based on factors significant on univariate analysis. RESULTS: Of 2740 women identified, 2018 (74%) received endocrine treatment without ovarian ablation, 516 (19%) received endocrine treatment plus ovarian ablation, and 206 (7.5%) did not receive endocrine treatment. Among patients undergoing ovarian ablation 282/516 (55%) received medical ovarian suppression, while 234 (45%) underwent bilateral salpingo-oophorectomy. By univariate logistic analyses, predictors for ovarian ablation were younger age (OR 0.97), histology (other vs ductal: OR 0.23), lymph node involvement (OR 1.89), higher International Federation of Gynecology and Obstetrics (FIGO) stage (stage II vs I: OR 1.48; stage III vs I: OR 2.86), higher grade (grade 3 vs 1: OR 3.41; grade 2 vs 1: OR 2.99), chemotherapy (OR 1.52), and more recent year of diagnosis (2014 vs 2010; OR 1.713). Only year of diagnosis, stage, and human epidermal growth factor receptor 2 (HER-2) treatment remained significant in the multivariate model. Within the cohort undergoing ovarian ablation, older age (OR 1.05) was associated with therapeutic bilateral salpingo-oophorectomy. Of 234 undergoing bilateral salpingo-oophorectomy, 12 (5%) mild to moderate adverse surgical events were recorded. CONCLUSIONS: Bilateral salpingo-oophorectomy is used frequently as an endocrine ablation strategy. Older age was associated with bilateral salpingo-oophorectomy. Perioperative morbidity was acceptable. Evaluation of long-term effects and quality of life associated with endocrine ablation will help guide patient/provider decision-making.
Subject(s)
Breast Neoplasms/surgery , Premenopause , Salpingo-oophorectomy/adverse effects , Adult , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Databases, Factual , Female , Gonadotropin-Releasing Hormone/administration & dosage , Humans , Middle Aged , Retrospective Studies , Salpingo-oophorectomy/methods , Salpingo-oophorectomy/statistics & numerical dataABSTRACT
OBJECTIVE: To evaluate the feasibility of an electronic symptom-tracking platform for patients recovering from ambulatory surgery. METHOD: We assessed user response to an electronic system designed to self-report symptoms. Endpoints included compliance, postoperative symptoms, patient satisfaction. An 8-item symptom inventory (pain, nausea, vomiting, shortness of breath, fever, swelling, discharge, redness) was developed and made available on postoperative days (POD) 2-6. Responses exceeding defined thresholds of severity triggered alerts to healthcare providers. Symptoms, alerts, actions taken, urgent care center (UCC) visits, hospital admissions were tracked until POD 30. Patient satisfaction was evaluated on POD 7. A patient was defined as "responder" if at least 5/8 items on at least 3 PODs were completed. The assessment method was deemed successful if 64/100 patients responded. RESULTS: 97/102 patients were evaluable; 65 met "responder" criteria (67% responder rate; 95% CI 57-76%). 321 surveys were completed (median 4/patient), 248 (77%) in ≤2 min. Involving caregivers and allowing additional symptom-reporting improved the responder rate to 72% (95% CI 58-84%). Most commonly-reported moderate, severe, very severe symptoms were pain, nausea, swelling; 71% reported moderate to very severe pain on POD 2. Phone calls and adjustment of medications adequately addressed most symptoms. Two patients (2%) presented at UCC before, 6 (6%) after, POD 6; 1 (1%) was admitted. Most agreed or strongly agreed that electronic symptom-tracking was helpful, easy to use, and would recommend it to others. CONCLUSION: Electronic symptom-tracking is feasible for patients undergoing ambulatory gynecologic cancer surgery. Symptom burden is high in the early postoperative period. Addressing patient-reported symptoms in a timely, automated manner may prevent severe downstream adverse events, reduce UCC visits and admission rates, and improve outcomes.
Subject(s)
Aftercare/methods , Genital Neoplasms, Female/surgery , Gynecologic Surgical Procedures/adverse effects , Internet-Based Intervention , Postoperative Complications/diagnosis , Adult , Aftercare/organization & administration , Ambulatory Surgical Procedures/adverse effects , Ambulatory Surgical Procedures/methods , Cancer Care Facilities/organization & administration , Feasibility Studies , Female , Gynecologic Surgical Procedures/methods , Humans , Middle Aged , Minimally Invasive Surgical Procedures/adverse effects , Minimally Invasive Surgical Procedures/methods , Outpatient Clinics, Hospital/organization & administration , Patient Readmission/statistics & numerical data , Patient Reported Outcome Measures , Patient Satisfaction/statistics & numerical data , Pilot Projects , Postoperative Complications/etiology , Postoperative Complications/therapy , Prospective Studies , Quality of Life , Self Report/statistics & numerical data , Treatment OutcomeABSTRACT
OBJECTIVE: To assess the efficacy of non-hormonal, hyaluronic acid (HLA)-based vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in women with a history of endometrial cancer. METHODS: For this single-arm, prospective, longitudinal trial, we enrolled disease-free women with a history of endometrial cancer who underwent surgery (total hysterectomy) and postoperative radiation. Participants used HLA daily for the first 2 weeks, and then 3×/week until weeks 12-14; dosage was then increased to 5×/week for non-responders. Vulvovaginal symptoms and pH were assessed at 4 time points (baseline [T1]; 4-6 weeks [T2]; 12-14 weeks [T3]; 22-24 weeks [T4]) with clinical evaluation, the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Female Sexual Function Index (FSFI), and Menopausal Symptom Checklist (MSCL). RESULTS: Of 43 patients, mean age was 59 years (range, 38-78); 54% (23/43) were partnered; and 49% (21/43) were sexually active. VAS, VuAS, MSCL, and SAQ (Sexual Activity Questionnaire) scores significantly improved from baseline to each assessment point (all p < .002). FSFI total mean scores significantly increased from T1 to T2 (p < .05) and from T1 to T4 (p < .03). At T1, 41% (16/39) felt confident about future sexual activity compared to 68% (17/25) at T4 (p = .096). Severely elevated vaginal pH (>6.5) decreased from 30% (13/43) at T1 to 19% (5/26) at T4 (p = .41). CONCLUSION: The HLA-based gel improved vulvovaginal health and sexual function of endometrial cancer survivors in perceived symptoms and clinical exam outcomes. HLA administration 1-2×/week is recommended for women in natural menopause; a 3-5×/week schedule appears more effective for symptom relief in cancer survivors.