A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study.

OBJECTIVES: Male rectal and anal cancer patients demonstrate high rates of sexual dysfunction. This pilot randomized controlled trial tested a psychoeducational intervention designed to improve psychosexual adjustment. METHODS: Rectal or anal cancer patients were randomized to a Sexual Health Intervention for Men (intervention) or to a referral and information control (control). The intervention included control activities plus 4 sexual health intervention sessions every 4-6 weeks and 3 brief telephone calls timed between these sessions. Assessments were completed pre-intervention (baseline) and 3 months (follow-up 1) and 8 months (follow-up 2) post-intervention. Differences were assessed with statistical significance and Cohen's d effect sizes (d = 0.2, small effect; d = 0.5, moderate effect; d = 0.8, large effect). RESULTS: Ninety subjects enrolled. Forty-three participants completed at least 1 follow-up assessment (intervention, n = 14; control n = 29). At follow-up 1, men in intervention, compared to control, improved on all domains of the International Index of Erectile Function (IIEF) (p < 0.001 to p < 0.05) and demonstrated large effects (d = 0.8 to d = 1.5). Similarly, at follow-up 2, changes in all domains of the IIEF except the orgasm domain were either statistically significant or marginally statistically significant (p = 0.01 to p = 0.08) and demonstrated moderate to large treatment effects for intervention versus control (d = 0.5 to d = 0.8). Men in the intervention, compared to control, demonstrated decreased sexual bother at follow-up 1 (p = 0.009, d = 1.1), while Self-Esteem and Relationship (SEAR) total scores and the SEAR sexual relationship subscale demonstrated moderate increases for intervention versus control (d = 0.4 to d = 0.6). SIGNIFICANCE OF RESULTS: This study provides initial evidence for combining a psychoeducational intervention with medical interventions to address sexual dysfunction following rectal and anal cancer. Trials register number: NCT00712751 (date of registration: 7/10/2008).

Effect of acupuncture versus usual care on sleep quality in cancer survivors with chronic pain: Secondary analysis of a randomized clinical trial.

BACKGROUND: Chronic pain negatively affects sleep; it is unclear whether pain relief from acupuncture contributes to sleep quality improvements in cancer survivors. This study aimed to evaluate the effect of acupuncture versus usual care on sleep quality among cancer survivors with comorbid sleep disturbance and chronic musculoskeletal pain. METHODS: Sleep outcome data from the Personalized Electroacupuncture Versus Auricular Acupuncture Comparative Effectiveness (PEACE) randomized clinical trial were analyzed. Electroacupuncture or auricular acupuncture was compared with usual care for sleep quality improvement over 10 weeks of treatment among cancer survivors with clinically significant sleep disturbance and chronic musculoskeletal pain at baseline. Sleep quality was measured with the Pittsburgh Sleep Quality Index (PSQI) global score. RESULTS: Among 268 participants (mean [standard deviation (SD)] age, 61.4 [12.6] years; 191 women [71.3%]; mean [SD] baseline PSQI global score, 10.3 [3.3] points), electroacupuncture and auricular acupuncture resulted in greater reductions in the PSQI global score from baseline to 10 weeks in comparison with usual care: 1.42 points (95% confidence interval [CI], 0.45-2.38; p = .004) and 1.59 points (95% CI, 0.62-2.55; p = .001), respectively. The improvement in sleep quality for the acupuncture groups was sustained for 24 weeks from randomization. Furthermore, a greater proportion of patients in the electroacupuncture and auricular acupuncture groups had clinically meaningful improvement in sleep quality compared to the usual care group (41.0% and 42.9% vs. 21.4%; p = .044). CONCLUSIONS: Among cancer survivors with comorbid sleep disturbance and chronic pain, electroacupuncture and auricular acupuncture produced a clinically relevant and persistent improvement in sleep quality. These findings suggest that acupuncture may be an evidence-based nonpharmacologic intervention to improve sleep health for cancer survivors with pain. PLAIN LANGUAGE SUMMARY: This study analyzed the sleep quality data from a published randomized clinical trial that evaluated the effect of electroacupuncture or auricular acupuncture versus usual care on pain relief among people who survived cancer. This analysis included a prespecified subgroup of 268 participants with co-occurring sleep disturbance and chronic musculoskeletal pain at baseline and found that patients who used acupuncture for pain relief demonstrated greater improvements in sleep quality compared with patients who received usual care. Sleep quality improvement by acupuncture was sustained after the treatment ended.

Mechanistic and thermal characterization of acupuncture for chemotherapy-induced peripheral neuropathy as measured by quantitative sensory testing.

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy. Acupuncture is a promising non-pharmacological intervention for CIPN. However, the physiological effects of acupuncture treatment remain poorly understood. We examined the effects of acupuncture on CIPN using semi-objective quantitative sensory testing (QST). METHODS: We conducted a randomized controlled trial of real acupuncture (RA) and sham acupuncture (SA) compared to usual care (UC) in cancer survivors with moderate-to-severe CIPN. Treatment response was assessed with QST measures of tactile and vibration detection thresholds in hands and feet, thermal detection, and pain thresholds at weeks 0, 8, and 12. Constrained linear mixed model (cLMM) regression was used for statistical analysis. RESULTS: 63 patients completed QST testing. At week 8, vibrational detection thresholds in feet were significantly lower in RA and SA (p = 0.019 and p = 0.046) than in UC, with no difference between RA and SA (p = 0.637). Both RA and SA also showed significantly higher cool thermal detection than UC (p = 0.008 and p = 0.013, respectively), with no difference between RA and SA (p = 0.790). No differences in tactile detection, vibrational detection in hands, warm thermal detection, and thermal pain thresholds were detected among the three arms at weeks 8 and 12. CONCLUSION: QST demonstrated different patterns in RA, SA, and UC. After eight weeks of RA, we observed significant improvements in the vibrational detection threshold in feet and cool thermal detection threshold in hands compared to UC. No significant differences were seen when compared to SA. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03183037); June 9, 2017.

Electro-acupuncture versus battle field auricular acupuncture in breast cancer survivors with chronic musculoskeletal pain: subgroup analysis of a randomized clinical trial.

PURPOSE: Chronic musculoskeletal pain is common and debilitating among breast cancer survivors. The PEACE trial demonstrated that electro-acupuncture (EA) and battle field auricular acupuncture (BFAA) both reduced pain more than usual care (UC) in cancer survivors. However, the comparative effectiveness between EA and BFAA among breast cancer survivors is unknown. METHODS: EA and BFAA received ten weekly treatments. UC was offered ten EA treatments after week 12. The primary endpoint was change in mean Brief Pain Inventory (BPI) pain severity from baseline to week 12. We analyzed the subset of 165 (46%) trial participants with a breast cancer primary diagnosis. We conducted constrained linear mixed model analyses, which constrained all arms to a common pre-randomization baseline mean. Model-based mean estimates at weeks 12 and 24 were compared between arms using model contrasts. RESULTS: Among 165 breast cancer survivors, common pre-randomization mean pain severity was 5.35 [95% Confidence Interval (CI) 5.04, 5.66]. At week 12, BPI pain severity score was 2.69 (2.26. 3.13) in EA, 3.60 (3.17, 4.02) in BFAA, and 5.06 (4.47, 5.65) in UC. EA reduced pain severity significantly more than BFAA at weeks 12 [- 0.90 (- 1.45, - 0.36), p = 0.001] and 24 [- 0.82, (- 1.38, - 0.27), p = 0.004]. EA and BFAA significantly improved both Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health physical health and mental health component scores at week 12 compared to UC. Mild toxicities were reported. CONCLUSION: EA was more effective than BFAA at reducing pain severity, but both similarly improved physical and mental health scores. Breast cancer survivors with chronic musculoskeletal pain may consider EA before BFAA. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02979574. https://clinicaltrials.gov/ct2/show/NCT02979574.

ASO Visual Abstract: Patient-Reported Outcome Measures in Patients with Clinical T4 Breast Cancer Treated with Mastectomy With and Without Reconstruction.

AIM: Do patient-reported outcome measures differ among clinical T4 patients undergoing mastectomy with and without reconstruction? FINDINGS: Neither reconstruction nor timing of reconstruction were associated with superior outcomes for breast satisfaction, physical well-being of the chest, or psychosocial well-being at any timepoint.

Patient-Reported Outcome Measures for Patients Who Have Clinical T4 Breast Cancer Treated via Mastectomy with and Without Reconstruction.

BACKGROUND: Patients with clinical T4M0 breast cancer are recommended to undergo neoadjuvant chemotherapy, modified radical mastectomy, and postmastectomy radiotherapy. This study determined whether BREAST-Q scores differ by decision to pursue reconstruction or timing of reconstruction. METHODS: This retrospective, single-institutional study analyzed cT4 breast cancer patients from 2014 to 2021 without evidence of distant metastatic disease undergoing mastectomy with or without reconstruction. As routine care, BREAST-Q was administered preoperatively, then 6 months, 1 year, and 2 years postoperatively. Satisfaction and quality-of-life domains were compared between mastectomy with no reconstruction (NR), immediate reconstruction (IR), and delayed reconstruction (DR) groups. RESULTS: Of the 144 patients eligible for this study, 71 (49%) had NR, 36 (25%) had DR, and 37 (26%) had IR. The patients undergoing reconstruction were younger and more likely to elect contralateral prophylactic mastectomy. Timing of reconstruction was not associated with significant differences in satisfaction with breasts (SATBR) at any time point. For the patients who had DR, breast satisfaction increased over time after reconstructive surgery. Physical well-being of the chest (PWB-CHEST) did not significantly differ among IR, DR, and NR at any time point. The patients who underwent DR experienced improvement in PWB-CHEST scores from preoperative scores. The patients with IR and NR experienced PWB-CHEST decline over time. Psychosocial well-being (PSWB) did not differ significantly across time or by subgroup. CONCLUSIONS: The patients with T4 breast cancer who elected reconstruction did not differ in patient-reported outcomes based on timing of reconstruction. In the DR cohort, SATBR significantly improved after reconstructive surgery. These data can help inform breast reconstructive decision-making for patients facing the choice among DR, IR, and NR.

What Proportion of Patients With Musculoskeletal Sarcomas Demostrate Symptoms of Depression or Anxiety?

BACKGROUND: It is estimated that the 12-month prevalence of depression in the United States is 8.6%, and for anxiety it is 2.9%. Although prior studies have evaluated depression and anxiety in patients with carcinoma, few have specifically evaluated patients with sarcoma, who often have unique treatment considerations such as mobility changes after surgery. QUESTIONS/PURPOSES: We evaluated patients with sarcoma seen in our orthopaedic oncology clinic to determine (1) the proportion of patients with depression symptoms, symptom severity, how many patients triggered a referral to mental health professionals based upon our prespecified cutoff scores on the nine-item Patient Health Questionnaire (PHQ-9), and if their symptoms varied by disease state; (2) the proportion of patients with anxiety symptoms, symptom severity, how many patients triggered a referral to mental health professionals based upon our prespecified cutoff scores on the seven-item Generalized Anxiety Disorder Scale (GAD-7), and if they symptoms varied by disease state; (3) whether other factors were associated with the proportion and severity of symptoms of anxiety or depression, such as tumor location in the body (axial skeleton, upper extremity, or lower extremity), general type of tumor (bone or soft tissue), specific diagnosis, use of chemotherapy, length of follow-up (less than 1 year or greater than 1 year), and gender; and (4) what proportion of patients accepted referrals to mental health professionals, when offered. METHODS: This study was a cross-sectional survey study performed at a single urban National Cancer Institute-designated Comprehensive Cancer Center from April 2021 until July 2021. All patients seen in the orthopaedic clinic 18 years of age and older with a diagnosis/presumed diagnosis of sarcoma were provided the PHQ-9 as well as the GAD-7 in our clinic. We did not track those who elected not to complete the surveys. Surveys were scored per survey protocol (each question was scored from 0 to 3 and summed). Specifically, PHQ-9 scores the symptoms of depression as 5 to 9 (mild), 10 to 14 (moderate), 15 to 19 (moderately severe), and 20 to 27 (severe). The GAD-7 scores symptoms of anxiety as 5 to 9 (mild), 10 to 14 (moderate), and 15 to 21 (severe). Patients with PHQ-9 or GAD-7 scores of 10 to 14 were referred to social work and those with scores 15 or higher were referred to psychiatry. Patients with thoughts of self-harm were referred regardless of score. Patients were divided based on disease state: patients during their initial management; patients with active, locally recurrent disease; patients with active metastatic disease; patients with prior recurrence or metastatic lesions who were subsequently treated and now have no evidence of disease (considered to be patients with discontinuous no evidence of disease); patients with no evidence of disease; and patients with an active, noncancerous complication but otherwise no evidence of disease. We additionally looked at the association of gender, chemotherapy administration, and tumor location on survey responses. Data are summarized using descriptive statistics. Differences across categories of disease state were tested for statistical significance using Kruskal-Wallis tests for continuous variables and Fisher exact tests for categorical variables as well as pairwise Wilcoxon rank sum tests. RESULTS: Overall, symptoms of depression were seen in 35% (67 of 190) of patients, at varying levels of severity: 19% (37 of 190) had mild symptoms, 9% (17 of 190) had moderate symptoms, 6% (12 of 190) had moderately severe symptoms, and 1% (1 of 190) had severe symptoms. Depresssion symptoms severe enough to trigger a referral were seen in 17% (32 of 190) of patients overall. Patients scored higher on the PHQ-9 during their initial treatment or when they had recurrent or metastatic disease, and they were more likely to trigger a referral during those timepoints as well. The mean PHQ-9 was 5.7 ± 5.8 during initial treatment, 6.1 ± 4.9 with metastatic disease, and 7.4 ± 5.2 with recurrent disease as compared with 3.2 ± 4.2 if there was no evidence of disease (p = 0.001). Anxiety symptoms were seen in 33% (61 of 185) of patients: 17% (32 of 185) had mild symptoms, 8% (14 of 185) had moderate symptoms, and 8% (15 of 185) had severe symptoms. Anxiety symptoms severe enough to trigger a referral were seen in 16% (29 of 185) of patients overall. Patients scored higher on the GAD-7 during initial treatment and when they had recurrent disease or an active noncancerous complication. The mean GAD-7 was 6.3 ± 3.2 in patients with active noncancerous complications, 6.8 ± 5.8 in patients during initial treatment, and 8.4 ± 8.3 in patients with recurrent disease as compared with 3.1 ± 4.2 in patients with no evidence of disease (p = 0.002). Patients were more likely to trigger a referral during initial treatment (32% [9 of 28]) and with recurrent disease (43% [6 of 14]) compared with those with no evidence of disease (9% [9 of 97]) and those with discontinuous no evidence of disease (6% [1 of 16]; p = 0.004). There was an increase in both PHQ-9 and GAD-7 scores among patients who had chemotherapy. Other factors that were associated with higher PHQ-9 scores were location of tumor (upper extremity versus lower extremity or axial skeleton) and gender. Another factor that was associated with higher GAD-7 scores included general category of diagnosis (bone versus soft tissue sarcoma). Specific diagnosis and length of follow-up had no association with symptoms of depression or anxiety. Overall, 22% (41 of 190) of patients were offered referrals to mental health professionals; 73% (30 of 41) accepted the referral. CONCLUSION: When treating patients with sarcoma, consideration should be given to potential concomitant psychiatric symptoms. Screening, especially at the highest-risk timepoints such as at the initial diagnosis and the time of recurrence, should be considered. Further work should be done to determine the effect of early psychiatric referral on patient-related outcomes and healthcare costs. LEVEL OF EVIDENCE: Level III, therapeutic study.

Characterization of chemotherapy-induced peripheral neuropathy using patient-reported outcomes and quantitative sensory testing.

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect in cancer survivors. This study aimed to assess the characteristics of quantitative sensory testing (QST) and its correlation with patient-reported outcomes (PROs) in cancer patients with and without CIPN. METHODS: We conducted a cross-sectional analysis using baseline data from two clinical trials in solid tumor cancer survivors with no CIPN symptoms rated < 2 on a 0-10 Numerical Rating Scale (NRS) or moderate-to-severe CIPN rated ≥ 4 on the NRS. We collected PROs (NRS, Neuropathic Pain Scale, and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity subscale at baseline. QST [Tactile Threshold (TT), Vibration Threshold (VT), Thermal Threshold (THT)] measurements were used to assess sensory fiber function; they were compared between patients with and without CIPN using Wilcoxon rank-sum tests. We used Spearman correlation coefficients to estimate associations between PROs and QST in all patients. RESULTS: Among 116 participants with CIPN (median NRS 5.00) and 10 participants without CIPN (median NRS 0.00), the median (interquartile range) TT was 3.84 (3.47, 4.12) and 3.53 (3.00, 3.84) in feet, respectively (p = 0.043). The median VT was 17.90 (9.42, 26.95) and 7.73 (5.94, 11.11) in feet, respectively (p = 0.001). Thermal cool threshold was 30.00 °C (28.90, 30.57) and 30.67 °C (30.57, 30.93), respectively (p = 0.007). Correlation coefficients between PROs and QST measures ranged between 0.02 and 0.50 in absolute magnitude. CONCLUSION: Patients with moderate-to-severe CIPN had significantly impaired tactile, vibratory, and thermal thresholds compared to patients without CIPN. QST correlates with PROs, suggesting CIPN symptom severity may correspond to sensory fiber functionality. QST may be incorporated into future CIPN research.

Longitudinal Analysis of Quality-of-Life Recovery After Gastrectomy for Cancer.

OBJECTIVE: The purpose of this study was to identify factors associated with quality-of-life recovery after gastrectomy. METHODS: Patients anticipated to undergo gastric cancer resection were invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30 and STO22 surveys in the preoperative setting and at 0-1.5 months (early), > 1.5-6 months (intermediate), and > 6-18 months (late) following resection. Quality-of-life recovery was measured as paired differences between pre- and postoperative results. Multivariable linear regression identified factors associated with preoperative quality of life and degree of change following resection. RESULTS: Across 393 participants, response rates at the intermediate and late postoperative time points were 58% (n = 228) and 71% (n = 277), respectively. Relative to baseline, median global health scale decreased in the early (- 15.1 pts, p < 0.001) and intermediate (- 3.6 pts, p = 0.02) time points, but recovered by the late time point (+ 1.2 pts, p = 0.411). Relative to distal/subtotal gastrectomy, proximal/total gastrectomy was associated with worse recovery in both the early and late time points. Surgical complications were associated with worse early recovery. Patients who presented with locally advanced tumors (T3-T4) had lower preoperative quality-of-life scores, and more readily recovered to baseline after surgery. A minimally invasive approach was not associated with postoperative recovery. CONCLUSIONS: Most patients recover to baseline within 1 year following major gastrectomy, and recovery is easier with more limited resections. Patients with locally advanced tumors tend to have poorer baseline quality of life, which may improve following resection.

Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer.

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.

A single-arm, prospective trial investigating the effectiveness of a non-hormonal vaginal moisturizer containing hyaluronic acid in postmenopausal cancer survivors.

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.

Prognostic Factors for Postrelapse Survival after ex Vivo CD34+-Selected (T Cell-Depleted) Allogeneic Hematopoietic Cell Transplantation in Multiple Myeloma.

Allogeneic hematopoietic cell transplantation (alloHCT) for multiple myeloma (MM), with its underlying graft-versus-tumor capacity, is a potentially curative approach for high-risk patients. Relapse is the main cause of treatment failure, but predictors for postrelapse survival are not well characterized. We conducted a retrospective analysis to evaluate predictors for postrelapse overall survival (OS) in 60 MM patients who progressed after myeloablative T cell-depleted alloHCT. The median patient age was 56 years, and 82% had high-risk cytogenetics. Patients received a median of 4 lines of therapy pre-HCT, and 88% achieved at least a partial response (PR) before alloHCT. Of the 38% who received preemptive post-HCT therapy, 13 received donor lymphocyte infusions (DLIs) and 10 received other interventions. Relapse was defined as very early (<6 months; 28%), early (6 to 24 months; 50%), or late (>24 months; 22%). At relapse, 27% presented with extramedullary disease (EMD). The median postrelapse overall survival (OS) by time to relapse was 4 months for the very early relapse group, 17 months for the early relapse group, and 72 months for the late relapse group (P = .002). Older age, relapse with EMD,

A single-arm clinical trial investigating the effectiveness of a non-hormonal, hyaluronic acid-based vaginal moisturizer in endometrial cancer survivors.

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.

Prevalence and Correlates of Worry About Medical Imaging Radiation Among United States Cancer Survivors.

PURPOSE: Cancer survivors undergo lifelong surveillance regimens that involve repeated diagnostic medical imaging. As many of these diagnostic tests use ionizing radiation, which may modestly increase cancer risks, they may present a source of worry for survivors. The aims of this paper are to describe cancer survivors' level of worry about medical imaging radiation (MIR) and to identify patterns of MIR worry across subgroups defined by cancer type, other medical and demographic factors, and physician trust. METHOD: This cross-sectional study used the 2012-2013 Health Information National Trends Survey of US adults conducted by the National Cancer Institute. The analysis focused on the 452 respondents identifying as cancer survivors. Weighted logistic regression analysis was used to evaluate factors associated with higher MIR worry (reporting "some" or "a lot" of MIR worry). RESULTS: Nearly half (42%) of the sample reported higher worry about MIR. Unadjusted and adjusted logistic regressions indicated higher rates of MIR worry among those with lower incomes, those who self-reported poorer health, and those who completed cancer treatment within the past 10 years. Receipt of radiation treatment was associated with higher MIR worry in unadjusted analysis. CONCLUSION: Worries about MIR are relatively common among cancer survivors. An accurate assessment of the rates and patterns of worry could aid efforts to improve these individuals' survivorship care and education.

Sexual health needs and educational intervention preferences for women with cancer.

PURPOSE: To assess sexual/vaginal health issues and educational intervention preferences in women with a history of breast or gynecologic cancer. METHODS: Patients/survivors completed a cross-sectional survey at their outpatient visits. Main outcome measures were sexual dysfunction prevalence, type of sexual/vaginal issues, awareness of treatments, and preferred intervention modalities. Descriptive frequencies were performed, and results were dichotomized by age, treatment status, and disease site. RESULTS: Of 218 eligible participants, 109 (50%) had a history of gynecologic and 109 (50%) a history of breast cancer. Median age was 49 years (range 21-75); 61% were married/cohabitating. Seventy percent (n = 153) were somewhat-to-very concerned about sexual function/vaginal health, 55% (n = 120) reported vaginal dryness, 39% (n = 84) vaginal pain, and 51% (n = 112) libido loss. Many had heard of vaginal lubricants, moisturizers, and pelvic floor exercises (97, 72, and 57%, respectively). Seventy-four percent (n = 161) had used lubricants, 28% moisturizers (n = 61), and 28% pelvic floor exercises (n = 60). Seventy percent (n = 152) preferred the topic to be raised by the medical team; 48% (n = 105) raised the topic themselves. Most preferred written educational material followed by expert discussion (66%, n = 144/218). Compared to women ≥50 years old (41%, n = 43/105), younger women (54%, n = 61/113) preferred to discuss their concerns face-to-face (p = 0.054). Older women were less interested in online interventions (52%, p < 0.001), despite 94% having computer access. CONCLUSION: Female cancer patients/survivors have unmet sexual/vaginal health needs. Preferences for receiving sexual health information vary by age. Improved physician-patient communication, awareness, and educational resources using proven sexual health promotion strategies can help women cope with treatment side effects.

R-MPV followed by high-dose chemotherapy with TBC and autologous stem-cell transplant for newly diagnosed primary CNS lymphoma.

High-dose methotrexate-based chemotherapy is the mainstay of treatment of primary central nervous system lymphoma (PCNSL), but relapses remain frequent. High-dose chemotherapy (HDC) with autologous stem-cell transplant (ASCT) may provide an alternative to address chemoresistance and overcome the blood-brain barrier. In this single-center phase-2 study, newly diagnosed PCNSL patients received 5 to 7 cycles of chemotherapy with rituximab, methotrexate (3.5 g/m(2)), procarbazine, and vincristine (R-MPV). Those with a complete or partial response proceeded with consolidation HDC with thiotepa, cyclophosphamide, and busulfan, followed by ASCT and no radiotherapy. Primary end point was 1-year progression-free survival (PFS), N = 32. Median age was 57, and median Karnofsky performance status 80. Following R-MPV, objective response rate was 97%, and 26 (81%) patients proceeded with HDC-ASCT. Among all patients, median PFS and overall survival (OS) were not reached (median follow-up: 45 months). Two-year PFS was 79% (95% confidence interval [CI], 58-90), with no events observed beyond 2 years. Two-year OS was 81% (95% CI, 63-91). In transplanted patients, 2-year PFS and OS were 81%. There were 3 treatment-related deaths. Prospective neuropsychological evaluations suggested relatively stable cognitive functions posttransplant. In conclusion, this treatment was associated with excellent disease control and survival, an acceptable toxicity profile, and no evidence of neurotoxicity thus far. This trial was registered at www.clinicaltrials.gov as NCT00596154.

Validation of Clinical Tools for Vaginal and Vulvar Symptom Assessment in Cancer Patients and Survivors.

INTRODUCTION: Health care professionals can play a pivotal role in promoting vulvovaginal health through assessment and appropriate intervention. AIM: To develop and validate brief clinical measurements to facilitate the identification of vulvovaginal symptoms in patients with and survivors of cancer. METHODS: One hundred seventy-five women survivors of cancer attending a Female Sexual Medicine and Women's Health Program from September 26, 2012 through October 31, 2014 completed the Vaginal Assessment Scale (VAS) and the Vulvar Assessment Scale (VuAS)-a modified version of the VAS that targets vulvar symptoms. Pelvic examination results were recorded using a clinical examination checklist. MAIN OUTCOME MEASURES: Internal consistency of the two scales was assessed using Cronbach α, and the correlation between scales and other outcomes was reported. RESULTS: The internal consistency measurements of the VAS and VuAS at the first visit were 0.70 and 0.68, which decreased to 0.53 and 0.66 at the last visit. The VAS composite and VuAS composite scores were moderately correlated with each other (0.42 and 0.45 at first and last visits, respectively). A strong correlation was observed between VAS pain with intercourse and Female Sexual Function Index (FSFI) pain with intercourse (-0.63 and -0.71 at the first and last visits, respectively). Worse pain with examination, worse functioning on the FSFI pain, lubrication, and total scores, and worse vulvar irritation were correlated with more severe symptoms on the VAS and VuAS. CONCLUSION: The VAS and VuAS are simple tools that can be used by clinicians to assess health concerns in women diagnosed with and treated for cancer. Validation is needed across diverse settings and groups of women.

Cognitive effects of donepezil therapy in patients with brain tumors: a pilot study.

Cognitive dysfunction is prevalent among brain tumor patients treated with radiotherapy (RT) and chemotherapy. However, there are no approved pharmacological interventions for cognitive dysfunction in cancer patients. The goal of this pilot study was to examine the efficacy of donepezil, an acetylcholinesterase inhibitor used to treat Alzheimer's disease, in improving cognitive functions in brain tumor patients previously treated with RT + chemotherapy or chemotherapy alone. Fifteen patients with a brain tumor received a single daily dose of donepezil for 24 weeks (5 mg for 4 weeks, then 10 mg for 20 weeks). Patients completed cognitive evaluations prior to initiating therapy (baseline), and about 12 weeks (mid-study) and 24 weeks (end-of-study) subsequent to initiation of donepezil therapy. The results of linear mixed models analysis, controlling for each patient's baseline cognitive test score, showed a significant post-baseline improvement in attention (WAIS-III digit span forward; p = 0.037), graphomotor speed (WAIS-III digit symbol; p = 0.035) and visual memory (BVMT-R-delay; p = 0.025). There was also an improvement in self-reported quality of life (FACT-Br, social well-being subscale; p = 0.01). The findings of this pilot study suggest that treatment with donepezil may improve some aspects of cognitive functions and quality of life in brain tumor patients. Similar findings were reported in two prior trials of donepezil in brain tumor survivors.

Body image and sexual function in women after treatment for anal and rectal cancer.

OBJECTIVE: Treatment for anal and rectal cancer (ARCa) often results in side effects that directly impact sexual functioning; however, ARCa survivors are an understudied group, and factors contributing to the sexual sequelae are not well understood. Body image problems are distressing and may further exacerbate sexual difficulties, particularly for women. This preliminary study sought to (1) describe body image problems, including sociodemographic and disease/treatment correlates, and (2) examine relations between body image and sexual function. METHODS: For the baseline assessment of a larger study, 70 women completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Colorectal Cancer-specific Module, including the Body Image subscale, and Female Sexual Function Index. Pearson's correlation and multiple regression evaluated correlates of body image. Among sexually active women (n = 41), hierarchical regression examined relations between body image and sexual function domains. RESULTS: Women were on average 55 years old (standard deviation = 11.6), non-Hispanic White (79%), married (57%), and employed (47%). The majority (86%) reported at least one body image problem. Younger age, lower global health status, and greater severity of symptoms related to poorer body image (p's < 0.05). Poor body image was inversely related to all aspects of sexual function (ß range 0.50-0.70, p's < 0.05), except pain. The strongest association was with Female Sexual Function Index Sexual/Relationship Satisfaction. CONCLUSION: These preliminary findings suggest the importance of assessing body image as a potentially modifiable target to address sexual difficulties in this understudied group. Further longitudinal research is needed to inform the development and implementation of effective interventions to improve the sexual health and well-being of female ARCa survivors.

Baseline characteristics and concerns of female cancer patients/survivors seeking treatment at a Female Sexual Medicine Program.

PURPOSE: The purpose of this study is to characterize patients seeking treatment at a Female Sexual Medicine and Women's Health Program and examine their sexual/vaginal health issues. METHODS: Data from clinical assessment forms were extracted from 509 women referred to the Female Sexual Medicine and Women's Health Program during/after cancer treatment. The form consists of a Vaginal Assessment Scale (VAS), vaginal health items, patient-reported outcomes (PROs) (Sexual Activity Questionnaire [SAQ], Sexual Self-Schema Scale [SSS], Female Sexual Function Index [FSFI]), and exploratory items. RESULTS: Of 509 patients, 493 (97 %) completed PROs; 253 (50 %) received a pelvic examination. The majority had a history of breast (n = 260, 51 %), gynecologic (n = 184, 36 %), or colorectal/anal (n = 35, 7 %) cancer. Mean age was 51.2 years; 313 (62 %) were married/partnered. Approximately two thirds had elevated vaginal pH scores (5-6.5 [35 %] or 6.5+ [33 %]) and minimal (62 %) or no (5 %) vaginal moisture. Eighty-seven patients (44 %) experienced pain during their exam (23 % mild, 11 % moderate, 1.5 % severe, and 8.5 % not indicated). Fifty-three percent engaged in sexual activity with a partner; only 43 % felt confident about future sexual activity. Ninety-three percent were somewhat to very concerned/worried about sexual function/vaginal health. Approximately half had moderate/severe dryness (n = 133, 51 %) and dyspareunia (n = 120, 46 %). The mean SSS score was 60.7, indicating a slightly positive sexual self-view. However, 93.5 % (n = 429) had an FSFI score <26.55, suggesting sexual dysfunction. CONCLUSIONS: At initial consult, women reported vaginal dryness, pain, and sexual dysfunction. For many women, pelvic exams showed elevated vaginal pH, lack of moisture, and discomfort with the exam itself. Future analyses will examine changes over time.