scholarly journals Psychosocial Telephone Counseling for Survivors of Cervical Cancer: Results of a Randomized Biobehavioral Trial

2015 ◽  
Vol 33 (10) ◽  
pp. 1171-1179 ◽  
Author(s):  
Lari Wenzel ◽  
Kathryn Osann ◽  
Susie Hsieh ◽  
Jo A. Tucker ◽  
Bradley J. Monk ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Repeated Measures ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Telephone Counseling ◽  
Longitudinal Change ◽  
Categorical Variables ◽  
Patient Reported ◽  
Cytokine Levels ◽  
Cancer Experience

Purpose Survivors of cervical cancer experience quality-of-life (QOL) disruptions that persist years after treatment. This study examines the effect of a psychosocial telephone counseling (PTC) intervention on QOL domains and associations with biomarkers. Patients and Methods We conducted a randomized clinical trial in survivors of cervical cancer, who were ≥ 9 and less than 30 months from diagnosis (n = 204), to compare PTC to usual care (UC). PTC included five weekly sessions and a 1-month booster. Patient-reported outcomes (PROs) and biospecimens were collected at baseline and 4 and 9 months after enrollment. Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures. Results Participant mean age was 43 years; 40% of women were Hispanic, and 51% were non-Hispanic white. Adjusting for age and baseline scores, participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants (all P < .05); significant differences in gynecologic and cancer-specific concerns (P < .05) were sustained at 9 months. Longitudinal change in overall QOL and anxiety did not reach statistical significance. Participants with decreasing interleukin (IL) -4, IL-5, IL-10, and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels. Conclusion This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer. The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship.

Safety profile of ripretinib, including impact of alopecia, and Palmar-Plantar Erythrodysesthesia Syndrome (PPES) on patient-reported outcomes (PROs), in ≥ fourth-line advanced gastrointestinal stromal tumors (GIST): Analyses from INVICTUS.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 11539-11539
Author(s):  
Suzanne George ◽  
Michael C. Heinrich ◽  
John Raymond Zalcberg ◽  
Sebastian Bauer ◽  
Hans Gelderblom ◽  
...  
Keyword(s):  
Safety Profile ◽  
Repeated Measures ◽  
Fixed Effects ◽  
Statistical Significance ◽  
P Value ◽  
Tolerability Profile ◽  
Patient Reported ◽  
The Impact ◽  
Advanced Gist ◽  
Over Time

11539 Background: Ripretinib is a novel switch-control TKI that broadly inhibits KIT and PDGFRA kinase signaling. In INVICTUS (NCT03353753), a randomized, double-blind, placebo (PBO)-controlled trial of ripretinib in ≥4th-line advanced GIST, ripretinib reduced the risk of disease progression or death by 85% vs PBO with a favorable overall safety profile. Common ( > 20%) adverse events (AEs) included, but were not limited to, alopecia and PPES. Exploratory analyses evaluated the impact of alopecia and PPES on quality of life (QoL). Methods: Patients (pts) with advanced GIST previously treated with at least imatinib, sunitinib, and regorafenib were randomized (2:1) to ripretinib 150 mg QD or PBO. AEs were graded using CTCAE v4 and PROs collected using EQ-5D-5L (EQ5D) and EORTC QLQ-C30 (C30). Repeated measures (RM) models assessed the impact of alopecia and PPES on 5 PROs (EQ5D visual analogue scale; and C30 physical functioning, role functioning, and the overall health and overall QoL questions) within the ripretinib arm. Fixed effects were sex, alopecia/PPES, and ECOG scores at baseline. Results: 128/129 randomized pts received treatment (85 ripretinib 150 mg QD; 43 PBO). Alopecia, regardless of causality, occurred in 44 (51.8%) on ripretinib (34 [40.0%] grade 1; 10 [11.8%] grade 2) and 2 (4.7%) on PBO (both grade 1). PPES occurred in 18 (21.2%) on ripretinib (11 [12.9%] grade 1; 7 [8.2%] grade 2); none on PBO. The median times in days to first occurrence and worst severity grade with ripretinib were 57.0 and 62.5 for alopecia; 56.5 and 57.0 for PPES. The RM models showed a slight trend towards improvement in PRO score over time for pts with alopecia; the only association reaching a P-value of < 0.05 was between alopecia and increased overall QoL. None of the associations between PPES and PRO scores reach P < 0.05. All PRO p-values are nominal, and no statistical significance is being claimed. Conclusions: Ripretinib had a favorable overall safety and tolerability profile. When stratified by alopecia and PPES, patient-reported assessments of function, overall health, and overall QoL were maintained over time. For both alopecia and PPES, onset and maximum severity occurred almost simultaneously, indicating that these events generally did not progressively worsen. These results suggest that alopecia and PPES are manageable and do not have a negative effect on function, overall health, and QoL. Clinical trial information: NCT03353753 .

Vanishing congenital lung malformations: What is the incidence of true regression?

2021 ◽  
pp. 1-7
Author(s):  
C. Griggs ◽  
M. Schmaedick ◽  
C. Gerall ◽  
W. Fan ◽  
C. Orlas ◽  
...  
Keyword(s):  
Neonatal Intensive Care ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Retrospective Chart Review ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Chi Square ◽  
Exact Test ◽  
Congenital Lung Malformation ◽  
Nicu Admission

BACKGROUND: A congenital lung malformation (CLM) that is diagnosed on prenatal ultrasound exam may subsequently become undetectable on later scans, a “vanishing” CLM. OBJECTIVE: The purpose of our study is to characterize the prenatal natural history and postnatal outcomes of “vanishing” lesions treated at our institution. METHODS: We performed a retrospective chart review of 107 patients diagnosed prenatally with CLM at our institution. Comparisons were made using Kruskal-Wallis or t-test for continuous variables and Fisher’s exact test or Chi-Square test for categorical variables. Multivariable analysis using logistic regression was performed. RESULTS: Of the 104 patients, 59 (56.7%) had lesions that became sonographically undetectable on serial ultrasound scans. Patients with lesions that vanished prenatally tended to need less Neonatal Intensive Care Unit (NICU) admission at birth (persistent CLM: 54.8%vs vanished CLM: 28.8%), decreased need for supplemental O2 at birth (persistent CLM: 31.0%vs vanished CLM: 11.9%), and decreased delay in feeds (persistent CLM: 26.2%vs vanished CLM: 8.5%) compared to those with persistent CLM. After multivariate analysis controlling for maternal steroid administration and sex, admission to NICU maintained a slight statistical significance, with patients in the vanishing CLM group 2.5 times less likely to be admitted to the NICU. None of our patients whose lesions vanished prenatally required mechanical ventilation. Eighty-six patients underwent postnatal computed tomography (CT) chest. Only 2 patients had lesions that regressed on postnatal CT. CONCLUSION: Lesions that vanish on prenatal imaging may be associated with improved clinical outcomes. The rate of true regression at our institution was as low as 2.3%.

scholarly journals P0012SHOULD WE DEFINE A NEW STANDARD PRESCRIPTION OF BICARBONATE (HCO3-) IN HEMODIALYSIS (HD)?

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Ana Rita Valerio Alves ◽  
Cátia Figueiredo ◽  
HernÂNi Ricardo Martins GonÇAlves ◽  
Karina Lopes ◽  
Flora Sofia ◽  
...  
Keyword(s):  
Renal Disease ◽  
Repeated Measures ◽  
Statistical Significance ◽  
Small Sample ◽  
Categorical Variables ◽  
Blood Levels ◽  
P Value ◽  
Disease Etiology ◽  
Time Points ◽  
Time Point

Abstract Background and Aims One of the aims of the regular, intermittent HD therapy prescribed for patients with end-stage chronic kidney disease, is correction of metabolic acidosis by addition of HCO3- to dialysate fluid. The KDOQI guidelines therapeutic goal is to maintain pre-dialysis HCO3-≥22mmol/L. The aim of the study was to evaluate an individualized HCO3-hemodialysis prescription as a preventing factor of metabolic changes in a HD facility and define a new standard HCO3-prescription. Method 36-month prospective study of patients on online high-flux hemodiafiltration. Every 3 months (13 time points) HCO3-, Calcium (Ca2+), Phosphorus (P+), intact Parathyroid hormone (iPTH) and protein C reactive (PCR) blood levels were analyzed. HCO3-prescription was changed using the following rules: The data collected comprised demographic information, renal disease etiology, comorbidities, HD treatment information and lab results. Categorical variables are presented as frequencies and percentages, continuous variables as means and standard deviations, or medians and interquartile ranges (IQR) for variables with skewed distributions. A p-value&lt;0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 23 for Mac OS X. Results From the 50 patients that were evaluated at Time point 0, only 24 patients completed the follow-up period. Sixteen (66.7%) were males, 54.2% (n=13) diabetic and 58.3% (n=14) hypertensives and the median age was 76 years (IQR 13). At baseline (time point 0), median pH was 7.4 (IQR 0.09) and serum HCO3-26.5 mmol/L (IQR 2.32). At time point 12, pH was 7.35 (IQR 0.12) and serum HCO3-23.25mmol/L (IQR 1.93). A repeated measures ANOVA determined that prescribed HCO3- differed with statistical significance during time (F(2.787,83.308)=39.055, p=0.001), and the post Hoc tests confirmed those assumptions between time point 1 and all the others time points, as an example the mean difference between initial prescribed HCO3-and time point 12 was 5.39mmol/L (p=0.001). Wilcoxon Sign-Rank Tests determined that throughout the analyzed period the serum HCO3- approached the reference serum HCO3- (23mmol/L) that we have defined as ideal (at time point 0, median=26.5mmol/L, Z=4.144, p=0-001; at time point 12, median 23.25mmol/L, Z=1.243, p=0.214). On the other hand, a one sample T-Test determined that the HCO3- prescription differed more in each time point from the 32mmol/L defined as standard (at time point 12, t=-2.798, p=0.01) and approached a new suggested value of 26mmol/L. However, at time point 8, 62.5% (n=15) patients had a HCO3-prescription of 28mmol/L, (t(23)=0.001,p=1) and at that time we had hypothesized that that a prescription of 28 mmol/L should be the new standard. Gender, Diabetes Mellitus, Hypertension, and renal disease etiology did not influence the HCO3- prescription neither serum HCO3-. Conclusion HCO3-prescription and serum HCO3- were not influenced by comorbidities like DM and Hypertension. Our findings suggest that the standard HCO3- prescription of 32mmol/L should be rethought, as an individualized HCO3- prescription could be beneficial for the patient. At this time, we suggest that a prescription of 26 mmol/L should be the new standard. However, the limitations of our findings include the small sample size, so further studies with larger samples should be attempted.

scholarly journals Patient-reported outcomes from the phase II FAST trial of zolbetuximab plus EOX compared to EOX alone as first-line treatment of patients with metastatic CLDN18.2+ gastroesophageal adenocarcinoma

2021 ◽  
Vol 24 (3) ◽  
pp. 721-730
Author(s):  
Florian Lordick ◽  
Salah-Eddin Al-Batran ◽  
Arijit Ganguli ◽  
Robert Morlock ◽  
Ugur Sahin ◽  
...  
Keyword(s):  
Disease Progression ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Symptom Burden ◽  
Progression Free Survival ◽  
First Line ◽  
Patient Reported ◽  
Gastroesophageal Adenocarcinoma ◽  
Eortc Qlq

Abstract Background Zolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma. Methods Patients were randomized to ZOL/EOX or EOX alone. Patients could receive ≤ 8 EOX cycles and remained on zolbetuximab until disease progression. PROs were collected using the EORTC QLQ-C30 and QLQ-STO22 before drug administration at day 1/cycle 1, day 1/cycle 5, end of EOX treatment, and q12w thereafter until disease progression. Time to deterioration (TTD), defined as the first meaningful worsening from baseline, in the individual QLQ-C30/QLQ-STO22 scores was analyzed. Longitudinal changes in scores from baseline were analyzed using a mixed-effects model for repeated measures (MMRM). Results The per protocol population included 143 (ZOL/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL/EOX over EOX and reached statistical significance for GHS (p = 0.008). MMRM results support TTD findings; no statistically significant differences were observed between arms in any score except for nausea and vomiting (p = 0.0181 favoring EOX). Conclusions ZOL/EOX allowed patients to maintain good QoL and low symptom burden for longer than EOX alone.

Lower risk of prostate cancer in patients with sedentary occupations presenting for a prostate biopsy: Analysis of a Veterans Affairs cohort.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 257-257
Author(s):  
Rimaz M. Khadir ◽  
Rashid K. Sayyid ◽  
Martha K. Terris
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
High Volume ◽  
Veterans Affairs ◽  
High Grade ◽  
Increased Risk ◽  
Patient Reported

257 Background: Sedentary behavior has been associated with increased serum prostate-specific antigen (PSA) levels. It is currently unknown whether this correlates with an increased risk of underlying prostate cancer (PCa). Our objective was to determine whether patients with sedentary occupations presenting for a prostate biopsy were at increased risk of PCa diagnosis. Methods: A prospectively collected registry of patients undergoing a prostate biopsy between July 1995 and June 2016 at the Veterans Affairs Medical Center in Augusta, GA was utilized. The occupation was classified as sedentary if it was associated with prolonged periods of sitting (i.e. >50% work hours). This was determined via patient reported history at time of biopsy. The associations between a sedentary lifestyle and risk of a positive prostate biopsy, high grade cancer (i.e. Gleason score 8 or higher), and high volume cancer (i.e. at least 50% of total cores were positive) were evaluated using multivariable logistic regression analyses, controlling for age, race, body mass index, PSA level, free PSA ratio, clinical stage, prostate volume, and family history of prostate cancer. Statistical significance was set at p<0.05. All statistical analyses were performed using R version 3.6.1. Results: Our cohort included 1,914 patients. 271 (14.2%) patients had sedentary jobs. Median patient age was 61.0 years (Interquartile range [IQR] 57.0 – 66.0). Median PSA at time of biopsy was 5.7 ng/ml (IQR 4.4 – 8.2). Of the 1,914 initial biopsies performed, 974 (50.9%) were positive for malignancy. Of patients diagnosed with PCa, 229 (23.5%) had high-grade disease and 316 (32.4%) had high volume disease. On multivariable analysis, patients with a sedentary job had a significantly decreased risk of PCa diagnosis (Odds ratio [OR] 0.43, 95% confidence interval [CI] 0.18-1.03, p= 0.058), but no difference in odds of high grade (OR 0.63, 95% CI 0.089-2.99, p= 0.60) or high volume disease (OR 1.07, 95% CI 0.93-1.21, p= 0.89). Conclusions: Patients with sedentary occupations presenting for a prostate biopsy are at a lower apparent risk for a positive prostate biopsy. These results suggest that the serum PSA levels in such patients may be artificially elevated secondary to increased recumbence with no corresponding increase in risk of malignancy. [Table: see text]

scholarly journals AB0749 COMPARING PATIENT-PHYSICIAN DISCORDANCE IN RA AND PsA PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1671.1-1671
Author(s):  
L. Brites ◽  
L. Saraiva ◽  
F. Costa ◽  
J. Dinis de Freitas ◽  
M. Luis ◽  
...  
Keyword(s):  
Disease Activity ◽  
Pain Assessment ◽  
Global Assessment ◽  
Disease Duration ◽  
Multivariable Analysis ◽  
Categorical Variables ◽  
Joint Involvement ◽  
Multivariable Logistic Regression Analysis ◽  
Physician Global Assessment ◽  
Patient Reported

Background:Patient global Assessment (PGA) of disease activity is considered a key patient reported outcome in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), both being included in combined indices of disease activity. However, patients and physicians frequently disagree in their assessment.Objectives:This study aimed at comparing the degree of this discrepancy and its determinants in RA and PsA.Methods:Cross sectional study including 100 patients with RA (ACR/EULAR 2010 criteria) and 100 patients with PsA with predominant peripheral joint involvement (CASPAR criteria), aged ≥18 years, randomly selected from the electronic registry Reuma.pt. Data were collected from the most recent rheumatology visit during the last year: sociodemographic data, disease duration (years), tender and swollen joint counts 0-28 (TJC and SJC), disease activity (DAS28 3V-PCR), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), patient’s pain assessment, PGA and physician global assessment (PhGA). The discrepancy between patients and physicians (ΔPPhGA) was defined as PGA minus PhGA, and a difference > |20mm| was taken as “discordance”. Categorical variables are presented as proportions and continuous variables as mean (±SD). Patient and clinical characteristics were compared between patients with RA and PsA using t- test and χ2 test, as adequate. Variables with p<0.05 or clinically relevant were included in multivariable logistic regression analysis to identify correlates for ΔPPhGA in the whole sample. A p≤0.05 was considered statistically significant.Results:Compared to PsA, patients with RA were more often female (90% Vs 49%,p< 0.05), older (66.7 ± 10.7 Vs 58.3 ± 12.2 years,p< 0.05) and had a shorter disease duration (18.2 ± 9.8 Vs 19.9 ± 9.7 years,p= 0.202). Regarding disease activity, the RA and PsA groups were comparable: DAS28 3V-PCR (2.3 ± 0.9 Vs 2.4 ± 1.0,p= 0.34). Patients with RA had a higher mean ΔPPhGA (30.4 ± 30.6 Vs 25.4 ± 27.5,p< 0.05), and were more frequently discordant to the physician (69% Vs 51%,p< 0.05). In univariable analysis, having RA, higher patient’s pain assessment and higher ESR were associated to patient-physician discordance. In multivariable analysis, only patient’s pain assessment (OR 1.04 [95% CI 1.03-1.06], p = 0.00) and TJC (OR 0.82 [95% CI 0.68-0.97], p = 0.02) remained as predictors of discordance.Conclusion:Despite comparable disease activity scores in RA and PsA patients, RA patients tend to have a worst self-perception of their disease activity compared to their physician´s. Patient’s pain assessment and TJC were the only predictors of patient-physician discordance, irrespective of the disease.Disclosure of Interests:Luisa Brites: None declared, LILIANA SARAIVA: None declared, Flavio Costa: None declared, João Dinis de Freitas: None declared, Mariana Luis: None declared, Ana Rita Prata: None declared, Helena Assunção: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, João Rovisco: None declared, Catia Duarte: None declared

scholarly journals Impact of Contralateral Symmetry Procedures on Long-Term Patient-Reported Outcomes following Unilateral Prosthetic Breast Reconstruction

2018 ◽  
Vol 35 (02) ◽  
pp. 124-128 ◽  
Author(s):  
Shantanu Razdan ◽  
Hina Panchal ◽  
Claudia Albornoz ◽  
Andrea Pusic ◽  
Colleen McCarthy ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Well Being ◽  
Contralateral Breast ◽  
Prosthetic Reconstruction ◽  
Patient Reported ◽  
The Impact

Background One aim of unilateral postmastectomy breast reconstruction (BR) is to restore symmetry with the contralateral breast. As such, unilateral prosthetic reconstruction often requires a contralateral symmetry procedure (CSP). There is sparse literature on the impact of CSPs on long-term patient-reported outcomes (PROs) such as satisfaction and health-related quality of life (HRQoL). This study aims to describe PROs following CSPs, using a validated PRO tool, BREAST-Q. The hypothesis is that CSPs are associated with greater patient-reported satisfaction and HRQoL. Methods This study is a single institutional analysis of prospectively collected BREAST-Q scores of patients who underwent unilateral prosthetic BR during 2011 to 2015. Women 18 years and older with BREAST-Q scores measured ≥ 9months after BR with or without CSP(s) at the time of expander replacement were included. Patients were classified into four subcohorts: augmentation, mastopexy, reduction, and no symmetry procedure (controls). Sociodemographic, clinical characteristics, and BREAST-Q scores were analyzed. Multivariable linear regression was performed. Results Of 553 patients, 67 (12%) underwent contralateral augmentation, 68 (12%) mastopexy, 93(17%) reduction, and 325 (59%) were controls. Mean follow-up time was 52 months. Satisfaction with breast and outcomes were higher in the augmentation compared with the control groups (p = 0.01). On multivariable analysis, augmentation remained an independent predictor of satisfaction with breast (p = 0.04). Physical well-being scores were lower for contralateral mastopexy and reduction compared with the controls with a trend toward statistical significance on multivariable models. Psychological and sexual well-being was similar across groups. Conclusion Prosthetic reconstruction with contralateral breast augmentation was associated with greater satisfaction with breast and reconstructive outcome. In contrast, breast reduction and mastopexy procedures demonstrated equivalent satisfaction with breasts compared with controls but may be associated with lower physical well-being. Such information can be used to improve the shared decision-making process for women who choose unilateral prosthetic BR.

Stress, immunity, and cervical cancer: Psychoneuroimmunologic (PNI) results of a randomized telephone counseling intervention

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8585-8585
Author(s):  
E. L. Nelson ◽  
L. B. Wenzel ◽  
K. Osann ◽  
B. J. Monk ◽  
A. Dogan-Ates ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Immune System ◽  
Statistical Significance ◽  
Telephone Counseling ◽  
Absolute Difference ◽  
T Helper ◽  
Counseling Intervention ◽  
Immune Parameters ◽  
Specific Cytotoxicity ◽  
Helper Type

8585 Background: The association between counseling benefit and improved cancer patient survival is controversial. If such an association exists, it requires biological control of tumor growth, with the immune system as the most likely effector arm. It is widely held that for anti-tumor immunity a T helper type 1 (Th1) immune response is more advantageous, by supporting antigen-specific cytotoxicity, than a T helper type 2 (Th2). The purpose of this study was to test potential QOL, neuroendocrine and immune benefits obtained from psychosocial telephone counseling (PTC). Methods: Fifty cervical cancer patients were randomized to PTC or usual care. QOL and biological specimens were collected at baseline (3–15 months post diagnosis), and four months post-enrollment, Time 2. QOL was assessed by the FACT-Cx. Saliva was collected for the evaluation of cortisol and DHEA. Blood was collected for evaluation of selected neuroendocrine and immune parameters. We defined a Th1:Th2 ratio based upon cytokine precursor frequency determined from ELISpot assays for interferon (IFN) gamma and interleukin-(IL-) 5 performed using anti-CD3 and anti-CD28 lymphocyte stimulation. Results: We demonstrated a significant improvement in overall QOL from baseline to Time 2 for PTC participants compared to the control population (absolute difference 8.15, p=0.05). We observed longitudinal changes, up to 15 fold, in the Th1:Th2 ratio. Improvement in QOL was significantly associated with an increased Th1 immune system bias and conversely a decline in QOL with a more pronounced Th2 bias, p= 0.0097 two tailed Fisher’s exact T test and Spearman Correlation Coefficient r= 0.6368 (p= 0.0002, two tailed). Evaluation of association between QOL and the neuroendocrine parameters, salivary cortisol and DHEA, demonstrated the predicted trends, but did not reach statistical significance. Conclusions: PTC can improve QOL for cervical cancer survivors. Importantly, we have shown for the first time that changes in QOL are significantly associated with a shift of immune system Th1:Th2 stance. This provides support for a biobehavioral model, which identifies potential mechanisms by which interventions that lead to improvement in QOL could also result in improved clinical outcomes. No significant financial relationships to disclose.

Predictors of retention in a cervical cancer survivorship study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6132-6132
Author(s):  
Lari B. Wenzel ◽  
Kathryn Osann ◽  
Susie Hsieh ◽  
Sandra Sappington ◽  
Diana Marquez ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Pilot Study ◽  
Dropout Rate ◽  
Telephone Counseling ◽  
Drop Out ◽  
Retention Rates ◽  
Stepwise Logistic Regression ◽  
Significant Depression ◽  
Cancer Experience ◽  
Confirmatory Trial

6132 Background: Women with cervical cancer experience numerous quality of life (QOL) disruptions. A completed pilot study indicated that QOL and key biomarkers could be improved with psychosocial telephone counseling (PTC). A confirmatory trial has recently completed accrual.The purpose of this study is to identify predictors of retention in this large biobehavioral trial, and examine retention differences between the pilot and confirmatory trial. Methods: Women with stage I – III cervical cancer diagnosed 9 – 30 months earlier were randomized to either PTC or usual care. PROs and biological specimens were collected prior to randomization (N=204), and 3 (T2) and 9 months post baseline. Sociodemographic, clinical and QOL variables were evaluated from baseline to T2 to identify predictors of study retention. Multiple measures, including the PROMIS Depression and Anxiety scales were entered into a multivariate stepwise logistic regression model to predict study retention. Results: In the multivariate model, being randomized to counseling (OR=4.4, 95% CI: 1.5-12.6), having clinically significant depression, defined as >1 SD above the 50th percentile (OR=4.2, 95% CI:1.7-10.5) and being single (OR=3.4, 95% CI: 1.3-9.2) were the most significant predictors of drop-out in the study overall. Among those in the counseling arm, depression is the strongest predictor of dropout, with a five times higher dropout rate (OR=5.2, 95% CI:1.9-15.6) than those with low to moderate levels of depression, or no depression. However, retention rates improved substantially overall from the pilot study (72%) to the confirmatory study (84%), in both study arms, and retention increased among Latinas from 60% in the pilot study to 83% in the current study, and from 52% to 81% among those with less than a high school education. Conclusions: Results from this analysis of predictors of retention indicate that enhanced attention to sociocultural disparities can improve study retention. Attending to baseline clinical depression may be a further consideration.

Patient-reported sexual and urinary function after open and robotic radical prostatectomy.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 120-120 ◽  
Author(s):  
Joseph C. Klink ◽  
Jianbo Li ◽  
Eric A. Klein ◽  
Jihad Kaouk ◽  
J. Stephen Jones ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Repeated Measures ◽  
Multivariable Analysis ◽  
High Volume ◽  
Urinary Continence ◽  
Gleason Grade ◽  
Time Points ◽  
High Volume Hospital ◽  
Patient Reported ◽  
Prospective Longitudinal

120 Background: Urinary continence (UC) and sexual function (SF) may be impacted differently after robotic-assisted laparoscopic (RALRP) versus open (ORP) radical prostatectomy. We compared UC and SF among patients treated by RALRP and ORP at a high-volume hospital who were enrolled in a prospective, longitudinal quality-of-life (QOL) protocol. Methods: Between 2007 and 2012, 516 patients treated by active surveillance, brachytherapy, cryotherapy, RALRP, and ORP were enrolled in a QOL protocol at our institution. The focus of this study is 361 patients who were treated by RALRP (N=190) and ORP (N=171). Functional outcomes were assessed at baseline and at 1, 3, 6, 12, and 24 months using a validated QOL instrument (Giesler RB et al. Qual Life Res 2000). SF was assessed by adding the scores from questions on the quality and frequency of erections. UC was assessed by adding the scores from three questions about the frequency and quantity of incontinence and pad usage. Wilcoxon rank sum test and linear regression multivariable analysis were used to assess SF and UC at each time point. Results: Treatment groups were similar in age, PSA, clinical stage, Gleason grade, BMI, baseline UC and SF scores and baseline PDE-5 inhibitor use (all P > 0.05), but the RALRP patients were slightly older (60 vs 61 years, p=0.04) and had larger prostates (38 vs 44 grams, p=0.001). On multivariate analysis, UC was worse in the RALRP cohort at 1 month (12.0 vs 10.9, P = 0.02), 3 months (9.9 vs 8.5, P = 0.01), and 6 months (8.1 vs 6.8, P=0.01) but was similar at 12 and 24 months (all P > 0.2). SF was similar between both RALRP and ORP at all time points (all P > 0.3). At 24 months, UC for RALRP and ORP was 7.1 vs. 6.4, respectively which was not significant in multivariable analysis (P = 0.5). Likewise, SF for RALRP and ORP was 5.3 vs. 6.2 (multivariable P = 0.9). On repeated measures analysis there was no difference between the groups in UC or SF (P=0.4 and 0.5, respectively). Conclusions: Prospectively collected, patient reported QOL endpoints for SF are similar after RALRP and ORP at all time points in a high-volume hospital. Final UC is similar between both techniques, although RALRP patients may experience a slightly slower return to continence.

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