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Purpose A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers. Methods Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale. Results Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia ( P  = 0.07) and sexual distress ( P  = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score ( P  = 0.04). Conclusions Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months. Implications for Cancer Survivors This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

Background Endometrial cancer survivors are at an increased risk of poor quality of life outcomes. Physical activity is positively associated with general quality of life in this population, however, little is known about how changes in physical activity may be associated with changes in specific aspects of quality of life. The aim of this secondary data analysis was to explore the relationships between change in physical activity and change in physical, mental, social, and other aspects of quality of life in endometrial cancer survivors receiving a physical activity intervention. Methods Endometrial cancer survivors ( N  = 100) participated in a telephone-based physical activity intervention for six months. At baseline and post-intervention we measured physical activity via accelerometry and ecological momentary assessment, and quality of life via the Short Form Health Survey (SF-36), the Quality of Life of Adult Cancer Survivors instrument, the Brief Symptom Inventory, the Pittsburgh Sleep Quality Index, and the Perceived Stress Scale. We conducted structural equation modeling path analyses to investigate how physical activity post-intervention was associated with the quality of life measures’ subscales post-intervention, adjusting for baseline levels and potentially confounding covariates. Results Increasing physical activity was positively associated with improvements in general health ( p  = .044), role limitation due to physical health ( p  = .005), pain ( p  = .041), and somatic distress ( p  = .023). There was no evidence to indicate that change in physical activity was associated with change in other aspects of quality of life. Conclusions Endometrial cancer survivors are at higher risk for suffering from challenges to physical quality of life, and findings from this study suggest that increasing physical activity may alleviate some of these problems. Further research is needed to determine whether other aspects of quality of life are linked to change in physical activity. Trial registration Trial registration number: NCT00501761 Name of registry: clinicaltrials.gov Date of registration: July 16, 2007. Date of enrollment: June 16, 2005.

The purpose of this electronic daily diary study was to examine the relation of pain to smoking and quit attempts among 34 cancer patients with pain enrolled in a smoking cessation program. Electronic daily diary assessments of pain and smoking were collected at the end of each day for a 2-week period during smoking cessation treatment. Pain experienced throughout the day was measured on a scale from 1 to 5, from \"no pain\" to \"pain as bad as you can imagine.\" Smoking was defined as the number of cigarettes smoked per day. Linear multilevel modeling was used in examining associations between pain and smoking. A within-person pain and smoking association was found, such that greater daily pain was linked to greater daily smoking within individuals, controlling for baseline symptoms, nicotine dependence, smoking urge, age, and gender. No between-person pain and smoking association was observed. Additionally, cancer patients with higher average pain across the 2-week assessment period were less likely to make a quit attempt (defined as a day on which participants smoked no cigarettes) during the study period. The findings of this study add to a nascent literature on pain and smoking by providing initial evidence that pain may be a barrier to quitting among cancer patients who smoke and have pain. Future research examining the effectiveness of integrated pain and smoking cessation treatment in this population may be warranted.

Introduction: The human papillomavirus (HPV) vaccine is recommended by the U.S. Centers for Disease Control and Prevention for routine vaccination of boys and girls to protect against HPV-related cancers and genital warts. To meet the Healthy People 2020 target for HPV vaccination, health care providers must understand the importance of strongly recommending the HPV vaccine to all eligible adolescents. We sought to determine HPV vaccination patterns among employees at a tertiary cancer center and their children and attitudes regarding HPV vaccination among the employees. Methods: All employees at a tertiary cancer center were invited to participate in a cross-sectional survey administered online during July and August 2015. The survey included questions about HPV vaccination of participants and their children, including reasons why vaccine-eligible employees and children had not been vaccinated. Results: Of those eligible, 13% of male and 33% of female employees and 44% of daughters and 24% of sons of employees had completed the vaccine series. The main reasons for not completing the series or not having one’s son completing the series were not knowing that the vaccine was needed and vaccine not recommended by a health care provider. The main reasons for not having one’s daughter complete the series were the two aforementioned reasons and daughter not yet sexually active. Conclusion: Opportunities exist to educate health care workers about the benefits of the HPV vaccine and to increase the number of providers who recommend HPV vaccination to their patients.

BackgroundAdjuvant ICIs are approved for melanoma, but challenges persist regarding irAEs and their long-term impact on quality of life (QOL). Existing data from clinical trials are limited to highly selected populations and predetermined endpoints, failing to capture real-world experiences and symptom variability. The pathogenesis of irAEs and associated symptoms remains poorly understood. This longitudinal prospective study (NCT04990726) aims to investigate irAEs, symptom burden, and immune/genetic biomarkers in adjuvant ICI-treated melanoma patients in real-world settings.MethodsA total of 240 surgically resected stage II/III/IV melanoma patients initiating adjuvant nivolumab/pembrolizumab, without prior systemic therapy or autoimmune diseases will be enrolled. An additional 35 patients undergoing active surveillance will serve as a comparative reference. Assessments and blood collection occur at baseline, months 1, 3, 6, 12, 18, and 24, and at the occurrence of irAEs. Patient-reported outcomes (PROs) are collected using validated questionnaires for QOL, fatigue, depression, and sleep disturbance. Real-time symptom reporting is facilitated through mobile technology. Primary outcomes include clinical characterization of irAEs (incidence, phenotypes, timing, severity) and quantifying symptom burden. Secondary outcomes focus on identifying immune pathways, therapeutic targets, and immune/genetic biomarkers. Bone health is assessed using dual-energy X-ray absorptiometry (DXA) and biomarkers.ResultsTo date, 47 patients were enrolled (table 1); follow-up ranged from 1–33 months; 30% of patients on adjuvant ICIs experienced ≥ grade 2 irAEs (hepatitis, pneumonitis, arthritis, polymyalgia rheumatica, hypothyroiditis, adrenal insufficiency, immune thrombocytopenic purpura), leading to treatment hold/discontinuation in 21% without treatment-related deaths. Tumor recurrence occurred in 33%. PROs assessment showed i) a significant decline in EORTC QLQ-C30 physical function scale from 3 to 6 months post ICIs (P=0.007), and cognitive functioning scale between 3 and 12 months (P=0.025), ii) significantly worse FACIT fatigue scale between baseline and 1 month (P=0.013) and 3 months (P=0.024), then trended towards less fatigue, iii) no significant differences in depression, anxiety, or stress scales between all timepoints in DASS-21, and iv) trend towards higher levels of sleep impairment in PROMIS score at 1 and 3 months and less impairment at 6 months (P=0.066) but no significant differences in sleep disturbance between all timepoints (P=0.348). Of 11 patients who underwent baseline DXA, 6 completed follow-ups at 12 months and none had osteoporosis. Biomarker analyses are pending.ConclusionsPreliminary findings show 30% experiencing irAEs, leading to treatment modifications but no treatment-related deaths. Fluctuations in physical function, cognitive functioning, fatigue, and sleep are observed, along with preserved bone health. Immune analysis will provide further insights.AcknowledgementsThis work receives support from Dr. Noha Abdel-Wahab’s National Institute of Health K01 Award (K01AI163412), the University of Texas MD Anderson Cancer Center Institutional Research Grant, the Division of Internal Medicine Developmental Award, the Bridge funding award, and the Cancer Survivorship Seed fund.Trial RegistrationNCT04990726Ethics ApprovalThe study obtained ethics approval from the institutional review board at the University of Texas MD Anderson Cancer Center (Protocol 2019–0390). All participants gave informed consent before taking part of this study.Abstract 444 Table 1Patient demographics and baseline characteristics

Spouses offer a primary source of support and may provide critical assistance for behavior change. A diet-exercise intervention previously found efficacious in improving cancer survivors’ lifestyle behaviors was adapted to utilize a couples-based approach. The aims were to test the feasibility of this couples-based (CB) intervention and compare its efficacy to the same program delivered to the survivor-only (SO). Twenty-two survivor-spouse couples completed baseline assessments and were randomized to the CB or SO interventions. The study surpassed feasibility benchmarks; 91% of survivors and 86% of spouses completed a 6-month follow-up. Survivors and spouses attended 94% and 91% of sessions, respectively. The SO survivors showed significant improvements on the 30-s chair stand and arm curl tests, weight, and fruit and vegetable (F and V) consumption. The CB survivors showed significant improvements on the 6-min walk and 2-min step tests, body weight, and fat and F and V consumption. Improvement in the 30-s chair stand and arm curl tests was significantly better for SO survivors. The SO spouses showed no significant changes in outcome measures, but the CB spouses showed significant improvements in moderate-to-strenuous physical activity, weight, and fat and F and V consumption. Weight loss was significantly greater in CB spouses compared to SO spouses. Findings demonstrate feasibility, warranting further investigation of CB approaches to promote lifestyle change among cancer survivors and spouses.

Purpose This study assessed whether the Patient-Reported Outcomes Measurement Information System (PROMIS) computer-adaptive tests (CATs) provided results similar to those of the Brief Symptom Inventory (BSI) with a low patient burden. Methods Secondary data analysis of 136 prostate cancer patients who completed the 53-item BSI and the PROMIS CATs assessing depression, anxiety, and hostility. Results The PROMIS CATs and BSI correlated significantly in measures of depression (.85), anxiety (.76), and anger/hostility (.66; p < .001 for all). Using our BSI cutoff points for depression, anxiety, and anger/hostility, ROC analysis yielded areas under the curve of .966 [standard error (SE) = .014, p < .001], .975 (SE = .012, p < .001), and .952 (SE = .027, p < .001), respectively. Conclusions PROMIS CATs were highly correlated with the BSI subscales, indicating that the CATs performed well compared with the BSI, a widely used psychosocial measure.

Toronto ONT -- Laurels and three hurrahs for Michael Valpy for three consecutive bull's eyes in his columns on immigration (July 13, 14 and 15).