Figure it out on your own: a mixed-method study on pelvic health survivorship care after gynecologic cancer treatments.

PURPOSE: Pelvic health issues after treatment for gynecological cancer are common. Due to challenges in accessing physiotherapy services, exploring virtual pelvic healthcare is essential. This study aims to understand needs, preferences, barriers, and facilitators for a virtual pelvic healthcare program for gynecological cancer survivors. METHODS: A multi-center, sequential mixed-methods study was conducted. An anonymous online survey (N=50) gathered quantitative data on pelvic health knowledge, opportunities, and motivation. Focus groups (N=14) explored patient experiences and consensus on pelvic health interventions and virtual delivery. Quantitative data used descriptive statistics, and focus group analyses employed inductive thematic analysis. Findings were mapped to the capability, opportunity, and motivation (COM-B) behavior change model. RESULTS: Participants reported lacking knowledge about pelvic health interventions and capability related to the use of vaginal dilators and continence care. Barriers to opportunity included lack of healthcare provider-initiated pelvic health discussions, limited time in clinic with healthcare providers, finding reliable information, and cost of physical therapy pelvic health services. Virtual delivery was seen favorably and may help to address motivational barriers related to embarrassment and frustration with care. CONCLUSION: Awareness of pelvic healthcare is lacking among people treated for gynecological cancer. Virtual delivery of pelvic health interventions is perceived as a solution to enhance access while minimizing travel, cost, embarrassment, and exposure risks. IMPLICATIONS FOR CANCER SURVIVORS: A better understanding of the pelvic health needs of individuals following gynecological cancer treatments enables the development of tailored virtual pelvic health rehabilitation interventions which may improve access to pelvic health survivorship care.

Implementation of individually tailored treatment plans in a group-based intervention for women with mixed vulvo-vaginal and sexual health concerns following cancer treatment: A feasibility study.

PURPOSE: This study evaluated a professionally-led, group-based vulvo-vaginal and sexual health (VSH) workshop for women diagnosed with cancer. The study goals were to: (1) implement and assess a novel group intervention for diverse VSH concerns; (2) explore post-workshop changes in symptom bother, motivation to use VSH treatments, and frequency of VSH treatment use; (3) examine post-workshop changes in sexual well-being. METHODS: A group-based educational workshop to address a variety of VSH concerns was developed and implemented. During the workshop, participants created an individualized treatment plan by selecting from various VSH treatment options presented. Treatment plan follow-ups were administered online at one-, two-, and three-months post-workshop. At baseline and three-month follow-up, participants completed online questionnaires to assess self-reported vulvo-vaginal symptoms, sexual function, sexual distress, and use of VSH strategies. RESULTS: 195 participants (age 20-81) attended workshops over a 2.5-year period. Individualized treatment plans were effectively completed by most participants (92%). Preliminary results show decreases in bother severity associated with VSH concerns post-workshop, stabilizing after 2 months. At three-month follow-up, participants reported increased use of VSH treatment strategies. Sexual satisfaction, sexual distress, and emotional impact of vulvovaginal symptoms also improved. CONCLUSIONS: Workshop attendance was associated with increased uptake of VSH treatment strategies and improvements in several parameters of sexual well-being. Findings indicate that individualized treatment plans can be implemented effectively in a group setting and that a one-time, group-based educational workshop can meaningfully impact VSH-related behavior change, reduce vulvo-vaginal symptom bother and promote sexual well-being in patients with diverse VSH concerns.

Overall Severe Morbidity After Chemo-Radiation Therapy and Magnetic Resonance Imaging-Guided Adaptive Brachytherapy in Locally Advanced Cervical Cancer: Results From the EMBRACE-I Study.

PURPOSE: To evaluate overall severe late morbidity (grade ≥3) in patients with locally advanced cervical cancer treated with chemo-radiation therapy and magnetic resonance image guided adaptive brachytherapy within the prospective EMBRACE-I study, and to compare the results with published literature after standard radiograph based brachytherapy (BT). METHODS AND MATERIALS: From 2008 to 2015 the EMBRACE-I study enrolled 1416 patients. Morbidity was assessed (Common Terminology Criteria for Adverse Events version 3.0) every 3 months the 1st year, every 6 months the second and third year, and yearly thereafter and 1251 patients had available follow-up on late morbidity. Morbidity events (grade 3-5) were summarized as the maximum grade during follow-up (crude incidence rates) and actuarial estimates at 3 and 5 years. To compare with the published literature on standard radiograph based BT, Common Terminology Criteria for Adverse Events scores from the EMBRACE-I study were retrospectively converted into a corresponding score in the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer system. RESULTS: In total, 534 severe events occurred in 270 patients; 429 events were grade 3 and 105 were grade 4 events. Actuarial estimates for grade ≥3 gastrointestinal (GI), genitourinary (GU), vaginal and fistula events at 5 years were 8.5% (95% confidence interval [CI], 6.9%-10.6%), 6.8% (95% CI, 5.4%-8.6%), 5.7% (95% CI, 4.3%-7.6%), and 3.2% (95% CI, 2.2%-4.5%), respectively. The 5-year actuarial estimate for organ-related events (GI, GU, vaginal, or fistula) was 18.4% (95% CI, 16.0%-21.2%). The 5-year actuarial estimate when aggregating all G≥3 endpoints (GI, GU, vaginal, fistulas, and non-GI/GU/vaginal) was 26.6% (95% CI, 23.8%-29.6%). Thirteen patients had a treatment-related death, 8 of which were associated with GI morbidity. CONCLUSIONS: This report assesses severe morbidity from the largest prospective study on chemo-radiation therapy and image guided adaptive brachytherapy for locally advanced cervical cancer to date. Severe late morbidity was limited per endpoint and organ category, but considerable when aggregated across organs and all endpoints. The late morbidity results in the EMBRACE-I study compare favorably with published literature on standard radiograph based BT for GI morbidity, vaginal morbidity, and fistulas.

Preferences, barriers and facilitators regarding virtual pelvic healthcare in individuals with gynaecological cancers: protocol for a patient-oriented, mixed-methods study.

INTRODUCTION: Vaginal pain during intercourse and urinary incontinence are common complaints after gynaecological cancer treatments. Pelvic health physiotherapy treatments aim at optimising function through education on the use of vaginal moisturisers, dilation therapy programme and pelvic floor muscle training. Given that barriers such as time, travel, and costs are known to limit access to physiotherapy services, a virtual pelvic health physiotherapy programme may help to facilitate access. The primary objective of this study is to identify preferences, barriers and facilitators from individuals with gynaecological cancer regarding virtual pelvic healthcare survivorship care. METHODS AND ANALYSIS: This patient-oriented, mixed-methods study will involve an online cross-sectional survey data (phase I) and qualitative data from a series of virtual focus groups (phase II). PHASE I: an anonymous survey will be used to assess the demographics, health status, prevalence of urogenital symptoms, as well as knowledge, barriers and facilitators to pelvic health services of people with gynaecological cancer. A total of N=50 participants from Canada will be recruited through convenience and self-selection sampling. PHASE II: a series of virtual semi-structured focus groups will be conducted with 10-15 participants on key topics related to virtual pelvic healthcare. Interviews will be audio-recorded and transcribed, from which key themes and quotes will be identified. An interpretive description qualitative method will guide analysis and implementation of results. ETHICS AND DISSEMINATION: Approval from the Health Research Ethics Board of Alberta-Cancer Committee (HREBA.CC-21-0498) and of the CISSS Bas-Saint-Laurent (CISSSBSL-2021-10) have been obtained. Informed, electronically signed consent will be required from all participants. Results from this work will be published in a peer-reviewed journal and will be used to inform the development and implementation of a new Pelvic eHealth Module for individuals treated for gynaecological cancers. This module will be incorporated into a comprehensive educational and exercise programme offered by a web-based application.

Association of persistent morbidity after radiotherapy with quality of life in locally advanced cervical cancer survivors.

PURPOSE: To quantify the association of persistent morbidity with different aspects of quality of life (QOL) in locally advanced cervical cancer (LACC) survivors. MATERIAL AND METHODS: Longitudinal outcome from the EMBRACE-I study was evaluated. Patient-reported symptoms and QOL were prospectively scored (EORTC-C30/CX24) at baseline and regular follow-ups. Physician-assessed symptoms were also reported (CTCAEv.3). Persistent symptoms were defined if present in at least half of the follow-ups. QOL items were linearly transformed into a continuous scale. Linear mixed-effects models (LMM) were applied to evaluate and quantify the association of persistent symptoms with QOL. Overall QOL deterioration was evaluated by calculating the integral difference in QOL over time obtained with LMM for patients without and with persistent symptoms. RESULTS: Out of 1416 patients enrolled, 741 with baseline and ≥ 3 late follow-ups were analyzed (median 59 months). Proportions of persistent EORTC symptoms ranged from 21.8 % to 64.9 % (bowel control and tiredness). For CTCAE the range was 11.3-28.6 % (limb edema and fatigue). Presence of any persistent symptom was associated with QOL, although with varying magnitude. Role functioning and Global health/QOL were the most impaired aspects. Fatigue and pain showed large differences, with reductions of around 20 % for most of the QOL aspects. Among organ-related symptoms, abdominal cramps showed the largest effect. CONCLUSION: Persistent symptoms are associated with QOL reductions in LACC survivors. Organ-related symptoms showed smaller differences than general symptoms such as fatigue and pain. In addition to optimizing treatment to minimize organ-related morbidity, effort should be directed towards a more comprehensive and targeted morbidity management.

Predictors of axillary node response in node-positive patients undergoing neoadjuvant chemotherapy for breast cancer.

BACKGROUND: The ability to accurately predict which patients will achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy could help identify those who could safely be spared the potential morbidity of axillary lymph node dissection. We performed a retrospective analysis of a cohort of clinically node-positive patients managed with neoadjuvant chemotherapy with the goal of identifying predictors of axillary pCR. METHODS: Eligible patients were aged 18 years or older, had clinical T1-T4, N1-N3, M0 breast cancer and received neoadjuvant chemotherapy followed by surgical axillary lymph node staging between 2001 and 2017 at Misericordia Hospital, Edmonton, Alberta. Patient data, including tumour characteristics, details of neoadjuvant chemotherapy, imaging results before and after neoadjuvant chemotherapy, and final pathologic analysis, were collected from the appropriate provincial electronic data repositories. We summarized the data using descriptive statistics. We characterized associations between clinical/tumour characteristics and pCR using univariate and multivariate regression analysis. RESULTS: Of the 323 patients included in the study, 130 (40.2%) achieved axillary pCR. Absence of residual disease in the breast was associated with axillary pCR (odds ratio 6.74, 95% confidence interval 2.89-15.67). HER2-positive, triple-negative and ER-positive/PR-negative/HER2-negative tumours were significantly associated with a pCR on univariate analysis; the association trended toward significance on multivariate analysis. CONCLUSION: Our findings support the routine use of neoadjuvant chemotherapy and sentinel lymph node biopsy in patients with an absence of residual disease in the breast, and potentially in those with HER2-positive or triple-negative subtypes, and highlight the ER-positive/PR-negative biomarker subtype as a potential predictor of nodal response.

Severity and Persistency of Late Gastrointestinal Morbidity in Locally Advanced Cervical Cancer: Lessons Learned From EMBRACE-I and Implications for the Future.

PURPOSE: The purpose was to evaluate patient- and treatment-related risk factors for physician-assessed and patient-reported gastrointestinal (GI) symptoms after radio(chemo)therapy and image guided adaptive brachytherapy in locally advanced cervical cancer. METHODS AND MATERIALS: Of 1416 patients from the EMBRACE-I study, 1199 and 1002 were prospectively evaluated using physician-assessed (Common Terminology Criteria for Adverse Events [CTCAE]) and patient-reported (European Organization for Research and Treatment of Cancer [EORTC]) GI symptoms, respectively. CTCAE severe grade (grade [G] ≥3) events were pooled according to the location in the GI tract (anus/rectum, sigmoid, and colon/small bowel). CTCAE G ≥2 and EORTC "very much" and "quite a bit" plus "very much" scores (≥ "quite a bit") were analyzed for individual symptoms with Cox regression. Logistic regression was used for persistent G ≥1 and EORTC ≥ "quite a bit" symptoms, defined if present in at least half of follow-ups. RESULTS: The incidence of G ≥3 events was 2.8%, 1.8%, and 2.3% for G ≥3 anus/rectum, sigmoid, and colon/small bowel events, respectively. Among G ≥2 symptoms, diarrhea and flatulence were the most prevalent (8.5% and 9.9%, respectively). Among patient-related factors, baseline morbidity, increasing age, smoking status, and low body mass index were associated with GI symptoms to varying degrees. Among treatment-related factors, rectum D2cm3 and the International Commission on Radiation Units and Measurements recto-vaginal reference point (ICRU RV-RP) correlated with G ≥3 anus/rectum events and moderate/persistent diarrhea, proctitis, bleeding, abdominal cramps, and difficulty in bowel control. Bowel D2cm3 correlated with G ≥3 sigmoid and colon/small bowel events and moderate/persistent diarrhea and flatulence. For external beam radiation therapy (EBRT), prescription dose correlated with G ≥3 anus/rectum, diarrhea, and difficulty in bowel control. Patients with large lymph-node boost (V57Gy) were at higher risk for G ≥3 sigmoid events, moderate/persistent diarrhea, proctitis, and cramps. CONCLUSIONS: The analysis showed that both EBRT and image guided adaptive brachytherapy contribute to GI symptoms after locally advanced cervical cancer treatment. Rectum D2cm3, ICRU RV-RP , and bowel D2cm3 are risk factors for GI morbidity. The risk for various symptoms was lower with an EBRT prescription of 45 Gy than 50 Gy and increased with larger V57Gy.

Impact of Vaginal Symptoms and Hormonal Replacement Therapy on Sexual Outcomes After Definitive Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: Results from the EMBRACE-I Study.

PURPOSE: To evaluate patient-reported sexual outcomes after chemoradiation therapy and image-guided adaptive brachytherapy for locally advanced cervical cancer in the observational, prospective, multicenter EMBRACE-I study. METHODS AND MATERIALS: Sexual outcomes were assessed prospectively with the European Organization for Research and Treatment of Cancer Qualify of Life Questionnaire (EORTC-QLQ-CX24) at baseline and follow-up. Crude incidence and prevalence rates of sexual activity, vaginal functioning problems (dryness, shortening, tightening, pain during intercourse), and sexual enjoyment were evaluated. Associations between pain during intercourse and vaginal functioning problems or sexual enjoyment were calculated, pooling observations over all follow-ups (Spearman correlation coefficient). In patients who were frequently sexually active (≥50% of follow-ups), the effects of regular hormonal replacement therapy (HRT) on vaginal functioning problems were evaluated (Pearson χ2). RESULTS: The analysis involved 1045 patients with a median follow-up of 50 months. Sexual activity was reported by 22% of patients at baseline and by 40% to 47% of patients during follow-up (prevalence rates). Vaginal functioning problems in follow-up were dryness (18%-21%), shortening (15%-22%), tightening (16%-22%), pain during intercourse (9%-21%), and compromised enjoyment (37%-47%). Pain during intercourse was significantly associated with vaginal tightening (r = 0.544), shortening (r = 0.532), and dryness (r = 0.408) and negatively correlated with sexual enjoyment (r = -0.407). Regular HRT was associated with significantly less vaginal dryness (P = .015), shortening (P = .024), pain during intercourse (P = .003), and borderline higher sexual enjoyment (P = .062). CONCLUSIONS: Vaginal functioning problems are associated with pain and compromised sexual enjoyment. Further effort is required for the primary prevention of vaginal morbidity with dose optimization and adaptation. Secondary prevention strategies, including HRT for vaginal and sexual health after radiation therapy in locally advanced cervical cancer, should be considered and sexual rehabilitation programs should be developed further.

DUCHESS: an evaluation of the ductal carcinoma in situ score for decisions on radiotherapy in patients with low/intermediate-risk DCIS.

BACKGROUND: Identification of women with DCIS who have a very low risk of local recurrence risk (LRR) after breast-conserving surgery (BCS) is needed to de-escalate therapy. We evaluated the impact of 10-year LRR estimates after BCS, calculated by the integration of a 12-gene molecular expression assay (Oncotype Breast DCIS Score®) and clinicopathological features (CPFs), on its ability to change radiation oncologists' recommendations for RT after BCS for DCIS. METHODS: Prospective cohort study of women with DCIS treated with BCS. Eligibility criteria were as follows: age > 45 years, tumor ≤ 2.5 cm, and margins ≥ 1 mm. Radiation oncologists provided 10-year LRR estimates without RT and recommendation for RT pre- and post-assay. Primary outcome was change in RT recommendation. RESULTS: 217 patients were evaluable, with mean age = 63 years, mean tumor size = 1.1 cm, and mean DCIS Score = 32; 140 (64%) were in the low-risk (<39), 32 (15%) were in the intermediate-risk (39-54), and 45 (21%) were in the high-risk groups (≥55). The assay led to a change in treatment recommendation in 76 (35.2%) (95%CI 29.1-41.8%) patients. RT recommendations decreased from 79% pre-assay to 50% post-assay (difference = 29%; 95%CI 22-35%) due to a significant increase in the proportion of patients with a predicted low LRR (< 10%) post-assay and recommendations to omit RT for those with a low predicted risk. The assay was associated with improved patient satisfaction and reduced decisional conflict. CONCLUSION: The DCIS Score assay combined with CPFs identified more women with an estimated low (<10%) 10-yr LR risk after BCS, leading to a significant decrease in recommendations for RT compared to estimates based on CPFs alone.

The Oncology and Sexuality, Intimacy, and Survivorship Program Model: An Integrated, Multi-disciplinary Model of Sexual Health Care within Oncology.

Cancer-related sexual dysfunction is documented as one of the most distressing and long-lasting survivorship concerns of cancer patients. Canadian cancer patients routinely report sexuality concerns and difficulty getting help. In response to this gap in care, clinical practice guidelines were recently published in the Journal of Clinical Oncology. A sweeping trend is the creation of specialized clinics for patients' sexual health concerns. However, this much-needed attempt to address this service gap can be difficult to sustain without addressing the cancer care system from a broader perspective. Herein, we describe the implementation of a tiered systemic model of cancer-related sexual health programming in a tertiary cancer center. This program follows the Permission, Limited Information, Specific Suggestions, Intensive Therapy (PLISSIT) model, used previously for guiding individual practitioners. Visually, the model resembles a pyramid. The top 2 levels, corresponding to Intensive Therapy and Specific Suggestions, are comprised of group-based interventions for common cancer-related sexual concerns and a multi-disciplinary clinic for patients with complex concerns. The bottom 2 levels, corresponding to Permission and Limited Information, consist of patient education and provider education and consultation services. We describe lessons learned during the development and implementation of this program, including the necessity for group-based services to prevent inundation of referrals to the specialized clinic, and the observation that creating specialized resources also increased the likelihood that providers would inquire about patients' sexual concerns. Such lessons suggest that successful sexual health programming requires services from a systemic approach to increase sustainability.

Dose-Volume Effects and Risk Factors for Late Diarrhea in Cervix Cancer Patients After Radiochemotherapy With Image Guided Adaptive Brachytherapy in the EMBRACE I Study.

PURPOSE: To evaluate patient- and treatment-related risk factors associated with incidence and persistence of late diarrhea after radiochemotherapy and image guided adaptive brachytherapy (IGABT) in locally advanced cervical cancer. MATERIALS AND METHODS: Of 1416 patients from the EMBRACE I study, 1199 were prospectively evaluated using physician-reported (Common Terminology Criteria for Adverse Events version 3 [CTCAEv3]) assessment for diarrhea; median follow-up 48 months. Patient-reported outcome (EORTC) was available in 900 patients. Incidence of CTCAE G≥2, G≥3, and EORTC "very much" diarrhea was analyzed with Cox proportional hazards regression. Binary logistic regression was used for analysis of persistent G≥1 and EORTC "quite a bit" - "very much" (≥"quite a bit") diarrhea, defined if present in at least half of all follow-ups. RESULTS: Crude incidences of G≥2 and G≥3 diarrhea were 8.3% and 1.5%, respectively, and 8% of patients reported "very much" diarrhea. Persistent G≥1 and ≥"quite a bit" diarrhea was present in 16% and 7%, respectively. Patient-related risk factors were baseline diarrhea, smoking, and diabetes with hazard ratios of 1.4 to 7.3. Treatment-related risk factors included prescribed dose, V43 Gy, V57 Gy (lymph node boost), and para-aortic irradiation for external beam radiation therapy (EBRT). G≥2 diarrhea at 3 years increased from 9.5% to 19.9% with prescribed dose 45 Gy versus 50 Gy, 8.7% to 14.0% with V43 Gy <2500 cm3 versus >3000 cm3 and 9.4% to 19.0% with V57 Gy <165 cm3 versus ≥165 cm3. Brachytherapy-related bowel and rectum D2cm3 were also associated with diarrhea. CONCLUSION: Dose and volume effects have been established for late diarrhea after radiochemotherapy and IGABT in both CTCAE and EORTC reporting. The risk of diarrhea was lower with a pelvic EBRT prescription of 45 Gy, and higher with larger lymph node boosts volumes (ie, ≥165 cm3). The importance of EBRT volumes as determinants of late toxicity underline the need for continuous quality assurance of target contouring, dose planning, and conformity. The findings of brachytherapy dosimetric factors related to the intestines may become more important with highly conformal EBRT.

Adjuvant breast radiotherapy, endocrine therapy, or both after breast conserving surgery in older women with low-risk breast cancer: Results from a population-based study.

BACKGROUND AND PURPOSE: The relative benefit of adjuvant radiotherapy (RT) alone in older women with low-risk early breast cancer (EBC) remains unclear. It is hypothesized that adjuvant RT-alone can improve outcomes of older patients with low-risk EBC, similar to endocrine therapy (ET) alone or combination of RT + ET. METHODS: In this population based study, we identified all women aged ≥70 with T1-2, N0, ER+ve, Her-2/neu-ve EBC treated with breast conserving surgery (BCS), followed by adjuvant treatments (RT-alone, ET-alone, or RT + ET combination) from 2005 to 2015. Primary outcome measures were recurrence-free survival (RFS), overall survival (OS), and breast cancer specific survival (BCSS). Treatment details were collected and Charlson Comorbidity Index (CCI) was calculated. RESULTS: A total of 1166 patients were identified. Median follow-up was 76.5 months. Adjuvant treatments: BCS only 130 (11%), RT 378 (32.5%), ET 161 (14%), and RT + ET 497 (42.5%). Less than 60% of women completed 5-years of ET. Compared to BCS alone, RT resulted in significant improvement in RFS (HR = 0.174; p < 0.001), similar to ET (HR = 0.414; p = 0.007) and RT + ET (HR = 0.236; p < 0.001). Determinants of OS were age, tumor grade, comorbidities, and adjuvant therapy. Increased comorbidity scores (0 vs. 1; 0 vs. ≥2) were associated with reduced OS (HR = 1.40; p = 0.013 and HR = 1.98; p < 0.001), without impact on RFS or BCSS. CONCLUSIONS: Adjuvant RT-alone is a reasonable alternative to ET or RT + ET for older women with biologically favorable EBC. No difference in RFS or BCSS was noted between RT, ET, and RT + ET. Comorbidity was independently associated with reduced overall survival.

Augmented Reality Guided Needle Biopsy of Soft Tissue: A Pilot Study.

Percutaneous biopsies are popular for extracting suspicious tissue formations (primarily for cancer diagnosis purposes) due to the: relatively low cost, minimal invasiveness, quick procedure times, and low risk for the patient. Despite the advantages provided by percutaneous biopsies, poor needle and tumor visualization is a problem that can result in the clinicians classifying the tumor as benign when it was malignant (false negative). The system developed by the authors aims to address the concern of poor needle and tumor visualization through two virtualization setups. This system is designed to track and visualize the needle and tumor in three-dimensional space using an electromagnetic tracking system. User trials were conducted in which the 10 participants, who were not medically trained, performed a total of 6 tests, each guiding the biopsy needle to the desired location. The users guided the biopsy needle to the desired point on an artificial spherical tumor (diameters of 30, 20, and 10 mm) using the 3D augmented reality (AR) overlay for three trials and a projection on a second monitor (TV) for the other three trials. From the randomized trials, it was found that the participants were able to guide the needle tip 6.5 ± 3.3 mm away from the desired position with an angle deviation of 1.96 ± 1.10° in the AR trials, compared to values of 4.5 ± 2.3 mm and 2.70 ± 1.67° in the TV trials. The results indicate that for simple stationary surgical procedures, an AR display is non-inferior a TV display.

Quality improvement in sexual health care for oncology patients: a Canadian multidisciplinary clinic experience.

PURPOSE: With the goal of improving the quality of sexual health care provision at our tertiary cancer centre, we developed, implemented, and assessed a multidisciplinary sexuality in an oncology program, to identify patient needs and apply interventions that could be effective in a broader oncology care context. METHODS: The establishment of our institution's first oncology-focused sexual health program is described within a quality improvement framework. A complementary retrospective chart review was performed to evaluate clinicodemographic data, including responses to validated sexual health questionnaires, from a 2-year clinical pilot. RESULTS: A sexual health program was introduced for cancer patients identified by health care providers or self-referred, receiving 130 referrals and conducting 64 consultation and 75 follow-up visits within a 2-year pilot period. Patients attending the program were 75% female, of mean age 52 years, and had most often breast (33%) or hematologic (30%) malignancies. Most (84%) had completed curative-intent treatment, with no evidence of disease, with 34% on ongoing endocrine therapy. The most frequent reasons for referral were sexual pain (38%), decreased libido (35%), and vaginal dryness (35% of females). All female patients demonstrated sexual dysfunction on the Female Sexual Function Index, and 80% of male patients demonstrated moderate to severe erectile dysfunction on the Sexual Health Inventory for Men. Patients waited a median of 63 days (SD 107, range 3-516) from referral to consultation, suggesting that demand for multidisciplinary sexual health care overwhelmed existing resources. CONCLUSIONS: We have demonstrated unmet sexual health needs across a diverse oncology patient population and have presented a framework for addressing these issues, highlighting the challenges encountered and proposing improvements. Insights emerging from a quality improvement perspective included the role of group-based sexual health support to improve accessibility and the need for staff education to encourage proactive intervention before referral for specialized care is needed.

Informal caregiver quality of life in a palliative oncology population.

PURPOSE: Many patients with advanced cancer receive primary supports from informal caregivers (IC). As patient health deteriorates, IC assume increasing responsibility, often accompanied by distress. We investigated the quality of life (QOL) of IC of patients referred to a palliative radiotherapy (PRT) program. METHODS: IC accompanying patients to a dedicated PRT clinic completed a survey based on the validated Caregiver Quality of Life Index-Cancer (CQOLC). Demographics, burden, and engagement in support services were evaluated. Summary statistics were calculated, and parameters were assessed for association with CQOLC scores by a generalized linear model. RESULTS: Two hundred one surveys were analyzed representing 197 unique patients. The mean age was 68.3 years, with predominantly lung (25.0%) and prostate (19.3%) malignancies. 24.4% had been in hospital/long-term care within the previous 7 days. IC were 60.8% female, and 60.6% were the patient's spouse. 69.5% lived with the patient and 38.3% were additionally employed. IC spent a daily mean of 6.6 h (SD 7) assisting with instrumental (72.5%) and basic (37.5%) activities of daily living. Mean CQOLC score was 82.1/140 (SD 20). 63.8% of IC had previously accessed support service(s), most commonly home care (37.2%) and pharmacy (29.1%). 55.9% indicated interest in services not yet accessed. Multivariate analysis revealed additional employment, cohabitation, poor patient performance status, and interest in accessing more support services significantly correlated with higher IC burden. CONCLUSIONS: Employing the CQOLC to screen IC of patients referred to a PRT program permits early identification of vulnerable IC to facilitate linkage with appropriate supports.

MRI-based interstitial brachytherapy for vaginal tumors: A multi-institutional study on practice patterns, contouring, and consensus definitions of target volumes.

PURPOSE: Interstitial brachytherapy (ISBT) can be effective for vaginal tumors due to its ability to deliver conformal treatment with 3D planning. As there is no consensus for 3D vaginal brachytherapy (BT) contouring, the goals of this study are to evaluate the variability in practices and contouring, and to develop consensus concepts on target definitions. METHODS: A survey/contouring study was conducted with 16 radiation oncologists from 10 Canadian academic centers. The study included three vaginal ISBT cases. Participants were provided staging, prebrachytherapy (pre-BT), and BT MRIs. Participants responded to a questionnaire and contoured on the provided images. Agreement between contours was analyzed. A meeting was held to develop consensus definitions of targets. RESULTS: Median ISBT experience was 3.5 years. All 16 participants regularly contour with MRI, whereas three also plan on MRI. For the three cases, there was variation into how CTVHR and CTVIR was defined. Kappa statistics showed higher agreement with bulky tumors (mean 0.59) as compared with small residual tumors (mean 0.29). For all cases, kappa was highest in pre-BT GTVres as compared with BT GTVres (mean 0.58, 0.46). Consensus concepts to define targets were developed. CONCLUSIONS: Variations exist in how ISBT targets are defined for vaginal tumors. Highest contouring variability was seen with small residual at BT. Contouring is more consistent on pre-BT MRI as compared with BT MRI suggesting a needle distortion effect. Consensus CTVHR and CTVIR definitions have been developed and further work is warranted to establish international standards.

Physician assessed and patient reported lower limb edema after definitive radio(chemo)therapy and image-guided adaptive brachytherapy for locally advanced cervical cancer: A report from the EMBRACE study.

BACKGROUND/PURPOSE: To evaluate the pattern of manifestation and risk factors for lower limb edema (LLE) within the prospective, observational, multi-center EMBRACE study on radiochemotherapy and MRI-guided brachytherapy in locally advanced cervical cancer (LACC). MATERIAL/METHODS: LLE was prospectively assessed according to the physician-reported CTCAE v.3 and patient-reported EORTC QLQ-CX24 questionnaire at baseline and regular follow-up. RESULTS: In total, 1176 patients were evaluated with a median follow-up of 27 months. Actuarial analyses revealed 3/5-year estimates of 27%/31% of CTCAE G ≥ 1, 6.1%/6.6% of G ≥ 2 and 0.5%/0.5% for G ≥ 3. Prevalence rates for G ≥ 1 LLE at 3 months, 1, 3 and 5 years after end of treatment were 7%, 12%, 12%, 15% for physician-assessed and 25%, 30%, 30%, 34% for any patient-reported symptoms and showed a steady increase over time. Invasive lymph node staging and obesity at diagnosis are independent significant risk factors for G ≥ 1 LLE, whereas nodal boost has no impact. Extended radiation fields including para-aortic and/or inguinal nodes show a tendency to increase the risk. CONCLUSION: Severe LLE after definitive radiochemotherapy in LACC is rare. However, the risk for mild LLE is considerable, and related to patient-, diagnostic- and treatment characteristics. Less invasive diagnostic surgical procedures or non-invasive assessment, less invasive radiotherapy management and active rehabilitation are important pathways for future developments.

The role of adjuvant therapy in stage IA serous and clear cell uterine cancer: A multi-institutional pooled analysis.

OBJECTIVE: As the optimal adjuvant management of stage IA serous or clear cell endometrial cancer is controversial, a multi-institutional review was conducted with the objective of evaluating the appropriateness of various strategies including observation. METHODS: Retrospective chart reviews for 414 consecutive patients who underwent hysterectomy for FIGO stage IA endometrial cancer with serous, clear cell or mixed histology between 2004 and 2015 were conducted in 6 North American centers. Time-to-event outcomes were analyzed by Kaplan-Meier estimates, log-rank test, univariable and multivariable cox proportional hazard regression models. RESULTS: Post-operative management included observation (50%), chemotherapy and radiotherapy (RT) (27%), RT only (16%) and chemotherapy only (7%). The 178 RT patients received external beam (EBRT, 16%), vaginal vault brachytherapy (VVB, 56%) or both (28%). Among patients without any adjuvant treatment, 5-year local control (LC), disease free survival (DFS) and cancer-specific survival (CSS) were 82% (95% confidence interval: 74-88), 70% (62-78) and 90% (82-94), respectively. CSS in patients without adjuvant treatment was improved with adequate surgical staging (100% vs. 87% (77-92), log-rank p=0.022). Adjuvant VVB was associated with improved LC (5-year 96% (91-99) vs. 84% (76-89), log-rank p=0.007) and DFS (5-year 79% (66-88) vs. 71% (63-77), log-rank p=0.033). Adjuvant chemotherapy was associated with better LC (5-year 96% (90-98) vs. 84% (77-89), log-rank p=0.014) and DFS (5-year 84% (74-91) vs. 69% (61-76), log-rank p=0.009). On multivariable analysis, adjuvant chemotherapy and VVB were associated with improved LC while adjuvant chemotherapy and age were significant for DFS. CONCLUSIONS: In stage IA serous or clear cell uterine cancer, adjuvant RT and chemotherapy were associated with better LC and DFS. Observation may be appropriate in patients who have had adequate surgical staging.

Consensus Recommendations for Radiation Therapy Contouring and Treatment of Vulvar Carcinoma.

PURPOSE: The purpose of this study was to develop a radiation therapy (RT) contouring atlas and recommendations for women with postoperative and locally advanced vulvar carcinoma. METHODS AND MATERIALS: An international committee of 35 expert gynecologic radiation oncologists completed a survey of the treatment of vulvar carcinoma. An initial set of recommendations for contouring was discussed and generated by consensus. Two cases, 1 locally advanced and 1 postoperative, were contoured by 14 physicians. Contours were compared and analyzed using an expectation-maximization algorithm for simultaneous truth and performance level estimation (STAPLE), and a 95% confidence interval contour was developed. The level of agreement among contours was assessed using a kappa statistic. STAPLE contours underwent full committee editing to generate the final atlas consensus contours. RESULTS: Analysis of the 14 contours showed substantial agreement, with kappa statistics of 0.69 and 0.64 for cases 1 and 2, respectively. There was high specificity for both cases (≥99%) and only moderate sensitivity of 71.3% and 64.9% for cases 1 and 2, respectively. Expert review and discussion generated consensus recommendations for contouring target volumes and treatment for postoperative and locally advanced vulvar cancer. CONCLUSIONS: These consensus recommendations for contouring and treatment of vulvar cancer identified areas of complexity and controversy. Given the lack of clinical research evidence in vulvar cancer radiation therapy, the committee advocates a conservative and consistent approach using standardized recommendations.

Customized vaginal vault brachytherapy with computed tomography imaging-derived applicator prototyping.

PURPOSE: A novel customized vaginal brachytherapy mould technique has been developed for clinical use. This image-guided technique provides a brachytherapy applicator solution for irregular vaginal vault configuration and/or a wide vaginal apex relative to the vaginal introitus that would be sub-optimally treated with standard cylinders. METHODS: The customized vaginal applicator is generated by the following process: CT images are obtained with contrast-soaked vaginal packing in situ to highlight unique anatomical detail. A 3-dimensional digital model is developed from the images and subsequently converted into a custom applicator with the use of stereolithography, which is an additive manufacturing technique whereby layers 50-100 µm thick of resin are deposited and polymerized using a laser to create intricate 3-dimensional objects. The density of the applicator and the dose delivered using the custom applicator were both measured to ensure accurate dosimetry. RESULTS: The CT-based densities of a clinical vaginal cylinder and the cylinder generated using stereolithography were 1.29 ± 0.06 g/cm(3) vs 1.28 ± 0.01 g/cm(3), respectively. The mean measured dose from a representative stereolithographed applicator normalized to dose measured for a single plastic catheter was 99.8 ± 4.2%. In patient dosimetric results indicate improved coverage of the lateral aspect of vaginal vault with the custom cylinder relative to the standard cylinder; 700 cGy vs 328 cGy, respectively, at a representative lateral vaginal dose point, while simultaneously achieving relatively narrow dose distribution in the anterior/posterior direction. CONCLUSIONS: Stereolithographic applicator production was available within a clinically acceptable timeframe, and its clinical feasibility and utility has been demonstrated.