Accrual and retention of diverse patients in psychosocial cancer clinical trials.

Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers. Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored. Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation. Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.

Impacts of Cognitive Behavioral Therapy for Insomnia and Pain on Sleep in Women with Gynecologic Malignancies: A Randomized Controlled Trial.

Insomnia is an adverse cancer outcome impacting mood, pain, quality of life, and mortality in cancer patients. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment for diverse psychophysiological disorders, including pain and insomnia. Primarily studied in breast cancer, there is limited research on CBT within gynecology oncology. This study examined CBT effects on subjective and behavioral sleep outcomes: Sleep Efficiency (SE), Sleep Quality (SQ), Total Wake Time (TWT), Sleep Onset Latency (SOL), and Wake After Sleep Onset (WASO). Thirty-five women with insomnia status/post-surgery for gynecologic cancer were randomized to CBT for insomnia and pain (CBTi.p., N = 18) or Psychoeducation (N = 17). Sleep was assessed via sleep diaries and wrist-worn actigraphy at baseline (T1), post-intervention (T2), and two-month follow-up (T3). Intent-to-treat analyses utilizing mixed linear modeling examined longitudinal group differences on sleep controlling for age and advanced cancer. All participants demonstrated improved (1) subjective SE (0.5, p < .01), SOL (-1.2, p < .01), TWT (-1.2, p < .01), and (2) behavioral SE (0.1, p = .02), TWT (-1.2, p = .03), WASO (-0.8, p < .01) across time. Group-level time trends were indicative of higher subjective SE (6.8, p = .02), lower TWT (-40.3, p = .01), and lower SOL (-13.0, p = .05) in CBTi.p. compared to Psychoeducation. Supplemental analyses examining clinical significance and acute treatment effects demonstrated clinical improvements in SE (T1), TWT (T2, T3), and SOL (T3). Remaining effects were not significant. Despite lacking power to detect interaction effects, CBTi.p. clinically improved sleep in women with gynecologic cancers and insomnia during the active treatment phase. Future research will focus on developing larger trials within underserved populations.

Robotic-assisted interval cytoreductive surgery in ovarian cancer: a feasibility study.

OBJECTIVE: The primary objective was to assess the feasibility of robotic-assisted interval cytoreductive surgery for achieving complete cytoreduction for patients with advanced-stage ovarian cancer. The secondary objective was to examine the perioperative outcomes. METHODS: A retrospective study of 12 patients with stage IIIC or IV ovarian, fallopian tube, and primary peritoneal carcinoma who underwent interval cytoreductive surgery after neo-adjuvant chemotherapy. RESULTS: Optimal cytoreduction was achieved in 100% of selected patients. Complete cytoreductive surgery was achieved in 75% of patients. The estimated mean blood loss was 100 mL. The median length of hospital stay was 2 days. Perioperative complication and 30-day readmission rates were 8.3% (1 patient). The median follow-up time was 9.5 months. CONCLUSION: Robotic-assisted interval cytoreductive surgery in ovarian cancer is safe and feasible and may be an alternative to standard laparotomy in selected patients.

Germline PALB2, ATM variants in a patient with breast and ovarian cancer at risk for familial cancer syndrome: Is there a role for risk-reducing salpingo-oophorectomy?

A 50-year-old non-Hispanic white Caucasian female was diagnosed with breast cancer and was subsequently found to possess the tumorigenic ataxia telangiectasia mutated (ATM) and PALB2 variants but not the BRCA1 and BRCA2 variants. She visited the gynecologic oncology office for routine counseling about risk-reducing salpingo-oophorectomy (RRSO). Although the patient was asymptomatic, an adnexal mass was discovered in the physical examination performed by palpation. Upon using pre-operative imaging techniques, an 8 cm complex adnexal mass was identified. Her CA-125 level was elevated. She underwent complete cytoreductive surgery. Pathological analysis showed a stage IC clear cell carcinoma of the left ovary; subsequently, she received 6 cycles of adjuvant chemotherapy with a combination of carboplatin and paclitaxel. The patient exhibited no signs ovarian cancer in a follow-up appointment after 32 months of treatment. However, bilateral RRSO is not recommended for patients positive for ATM and PALB2. Breast cancer patients with PALB2 and ATM mutations should extensively discuss the risks and benefits of RRSO in light of current data.

Associations Among Sleep Latency, Subjective Pain, and Thermal Pain Sensitivity in Gynecologic Cancer.

OBJECTIVE: Pain is common among women with gynecologic cancer and contributes to depressed mood, sleep disturbances, and likelihood of future chronic pain. Little is known about how psychosocial factors are associated with central sensitization of pain in gynecologic cancer. This study examined relations among depressive symptoms, sleep, subjective pain, and aftersensation pain (a proxy for central sensitization of pain) in gynecologic cancer. METHODS: Participants were 42 women (mean age [SD] = 59.60 [10.11] years) enrolled in a randomized clinical trial examining psychological intervention effects on sleep, pain, mood, and stress hormones/cytokines in gynecologic cancer. Six to eight weeks after surgery, participants completed an assessment of depressive symptoms, sleep, and subjective pain and a temporal summation of pain protocol via quantitative sensory testing (QST). RESULTS: Controlling for recent chemotherapy, history of chronic pain, and analgesic medication use, regression analyses revealed that longer sleep onset latency (SOL; B = 3.112, P = 0.039, bias-corrected and accelerated (BCa) 95% confidence interval [CI] = 0.371 to 6.014) and greater sensory pain (B = 0.695, P = 0.023, BCa 95% CI = 0.085 to 1.210) were associated with greater aftersensation pain at 15 seconds. Greater sensory pain scores were associated with greater aftersensation pain at 30 seconds (B = 0.286, P = 0.045, BCa 95% CI = 0.008 to 0.513). Depression was not associated with aftersensation pain. The overall models accounted for 44.5% and 40.4% of the variance in aftersensation pain at 15 and 30 seconds, respectively. Conclusions. Longer SOL and higher subjective sensory pain were related to greater aftersensation of experimentally induced pain in women postsurgery for gynecologic cancers. Interventions that improve sleep and subjective sensory pain during the perisurgical period may reduce risk for central sensitization of pain.

Interleukin-6 and body mass index, tobacco use, and sleep in gynecologic cancers.

OBJECTIVE: Elevated body mass index (BMI), tobacco use, and sleep disturbance are common health concerns among women with gynecologic cancers. The extent to which these factors are associated with systemic inflammation in gynecologic cancers is unknown. This is a significant literature gap given that (a) chronic, systemic inflammation may mediate relationships between behavioral health factors and cancer outcomes; and (b) elevated BMI, tobacco use, and sleep disturbances can be modified via behavioral interventions. This study examined Interleukin-6 (IL-6) relations with BMI, tobacco use history, and sleep disturbances in patients undergoing surgery for suspected gynecologic cancer. METHOD: Participants were 100 women (M age = 58.42 years, SD = 10.62 years) undergoing surgery for suspected gynecologic cancer. Smoking history was determined by participant self-report. Sleep quality/disturbance was assessed via the Pittsburgh Sleep Quality Index. BMI was abstracted from electronic health records. Presurgical serum IL-6 concentrations were determined using Enzyme-Linked Immunosorbent Assay. RESULTS: Controlling for the cancer type and stage, regression analyses revealed higher BMI, ß = 0.258, p = .007, and former/current smoking status, ß = 0.181, p = .046, were associated with higher IL-6. IL-6 did not differ between former and current smokers, ß = 0.008, p = .927. Global sleep quality, sleep latency, and sleep efficiency were not associated with IL-6. CONCLUSIONS: Higher BMI and any history of tobacco use predicted higher IL-6 among women undergoing surgery for suspected gynecologic cancers. Cognitive-behavioral interventions targeting primary and secondary obesity and tobacco use prevention may reduce systemic inflammation and optimize cancer outcomes in this population. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Minimally invasive interval cytoreductive surgery in ovarian cancer: systematic review and meta-analysis.

The introduction of minimally invasive surgery in other gynecologic cancers has shown benefits with similar oncologic outcomes. However, the biology and complexity of surgery for ovarian cancer may preclude this approach for ovarian cancer patients. Our objective is to assess feasibility to achieve complete cytoreductive surgery after neoadjuvant chemotherapy for stage IIIC-IV ovarian cancer patients via minimally invasive surgery. Our data sources include PubMed, Embase, Scopus, Biosis, Clinicaltrials.gov, and the Cochrane Library. Meta-analysis was performed using the random-effects model with DerSimonian and Laird estimator for the amount of heterogeneity to estimate the pooled outcomes. A funnel plot and Egger's regression test were used to test publication bias. The Newcastle-Ottawa Quality Assessment Scale was used to assess the quality of the studies. There were 6 studies (3 prospective, 3 retrospective) that met the criteria for meta-analysis with a total of 3231 patients, 567 were in the minimally invasive group and 2664 in the laparotomy group. Both groups were similar in stage and serous histology. Complete cytoreductive surgery was achieved in 74.50% (95% CI 40.41-97.65%) and 53.10% (95% CI 4.88-97.75%) of patients in the minimally invasive and laparotomy groups, respectively. There was no statistical significant difference between these 2 pooled proportions (p = 0.52). Three studies compared minimally invasive surgery vs laparotomy. No significant difference was observed between the 2 groups in obtaining complete cytoreductive surgery [OR = 0.90 (95% CI 0.70-1.16; p = 0.43)]. A symmetrical funnel plot indicated no publication bias. The pooled proportion for grade > 2 postoperative complications was not significant among the laparoscopy group [3.11% (95% CI 0.00-10.24%; p = 0.15)]. Complete cytoreductive surgery appears feasible and safe with minimally invasive surgery in selected advanced ovarian cancer patients after neoadjuvant chemotherapy.

Bevacizumab Eligibility in Patients with Metastatic and Recurrent Cervical Cancer: A Retrospective Review.

OBJECTIVE: Bevacizumab is approved for use in combination with chemotherapy for metastatic/recurrent cervical cancer (CC), with increased survival/response rates. However, use of bevacizumab is not always feasible or safe. The purpose of this study was to identify the percentage of metastatic/recurrent CC patients at our institution who would have been eligible to receive bevacizumab. METHODS: A retrospective study was conducted to identify metastatic/recurrent CC patients treated at UFHealth between 2006 and 2016. Chart review was performed to determine if the patient met bevacizumab eligibility criteria. RESULTS: In total, 79 patients with metastatic/recurrent CC were identified; 85.5% would have been ineligible to receive bevacizumab, and 14.5% would have been eligible. The most common reason for exclusion was active bleeding (68.4%); 94% of which was vaginal. In all, 27.6% would be excluded due to poor renal function, and 23.7% due to poor performance status (PS). CONCLUSIONS: Despite improved survival, only 14.5% of metastatic/recurrent CC patients treated over a 10-year period would have been eligible to receive bevacizumab. Most patients would have been excluded due to active bleeding, most commonly vaginal bleeding, a common complication from their disease. Identifying novel therapies for metastatic/recurrent CC patients with improved safety profiles that would allow for their use in this challenging population is critical.

Endometrial Thickness as Measured by Transvaginal Ultrasound and the Corresponding Histopathologic Diagnosis in Women With Postmenopausal Bleeding.

Endometrial thickness as measured by transvaginal ultrasound (TVUS) is being increasingly used as a first-line method to evaluate patients with vaginal bleeding. Our study aims to examine correlation between the histopathologic diagnosis and the results of TVUS and find a threshold that could reliably exclude carcinoma. We included women, age 55 years and above, who presented with postmenopausal bleeding and had a TVUS within 30 days of their endometrial biopsy. Total of 304 patients met our criteria and were divided into 4 groups. Patients in group A (n=198) had benign/atrophic endometrium, group B (n=44) had polyps, group C (n=30) had hyperplasia, and group D (n=32) had carcinoma. The endometrial thickness obtained by TVUS was compared with the histopathologic finding of the endometrial biopsy. The mean endometrial thickness was 7.5, 12.1, 14.8, and 16.9 mm for groups A to D, respectively. Statistical analysis showed that very low endometrial thickness (3 to 4 mm) would be ideal to use as a threshold to maximize sensitivity. Three of 32 patients in group D had an endometrial thickness ≤4 mm. At a threshold of 4 mm, the sensitivity is 90.6% and increases to 96.9% when decreasing the threshold to 3 mm. However, other parameters such as test accuracy, specificity, and positive predictive values are very low at these thresholds. Sensitivity can be maximized to 96.9% using a threshold of 3 mm. However, this would call into question the cost-effectiveness of this method. Postmenopausal bleeding remains the most reliable indicator of endometrial pathology.

Outcomes of Definitive Radiation Therapy for Primary Vaginal Carcinoma.

OBJECTIVE(S): The aim of this study was to review treatment and outcomes of patients with primary vaginal cancer treated with definitive radiotherapy. MATERIALS AND METHODS: We retrospectively reviewed medical records of 71 patients with primary vaginal adenocarcinoma or squamous cell carcinoma treated with definitive radiotherapy with at least 2 years of follow-up (median follow-up, 6.24 y). RESULTS: Ninety-three percent of patients were treated with external-beam radiotherapy plus brachytherapy (median dose, 7540 cGy); 4 patients with stage I disease and 1 patient with stage II disease were treated with brachytherapy alone (median dose, 6000 cGy). The cause-specific 5- and 10-year survival rates, respectively, were 96% and 96% for stage I patients, 75% and 68% for stage II patients, 69% and 64% for stage III patients, and 53% and 53% for stage IVA patients. The 5- and 10-year local-regional control rates for all patients were 79% and 75%, respectively. The 5- and 10-year distant metastasis-free survival rates for all patients were 87% and 85%, respectively. Sixteen patients had tumors involving the distal one third of the vagina. Of the 7 who received elective inguinal node irradiation, 0 failed in the inguinal nodes. Of the 9 who did not receive elective inguinal node irradiation, 2 failed in the inguinal nodes. Severe complications (grades 3 to 4) occurred in 16 patients (23%). CONCLUSIONS: Radiotherapy provides excellent results as definitive treatment for primary vaginal cancer, although the risk of severe complications is high. Generally, treatment should consist of both external-beam radiation therapy and brachytherapy. Inguinal nodes should be irradiated electively when the primary tumor involves the distal one third of the vagina.