Physical Well-being Scale Research Articles

Patient-Reported Adverse Events and Early Treatment Discontinuation Among Patients With Multiple Myeloma

There is substantial interest in capturing cancer treatment tolerability from the patient's perspective using patient-reported outcomes (PROs). To examine whether a PRO question, item 5 from the Functional Assessment of Cancer Therapy-General General Physical Wellbeing Scale (GP5), was associated with early treatment discontinuation (ETD) due to adverse events. This prospective survey study was conducted from February to April 2023. Among participants in the ECOG-ACRIN E1A11 trial (a phase 3, parallel design trial conducted between 2013 and 2019), patients with newly diagnosed multiple myeloma were randomized to receive bortezomib (VRd) or carfilzomib (KRd) plus lenalidomide and dexamethasone as induction therapy. The GP5 item was administered at baseline (pretreatment) and at 1 month, 2.8 months, and 5.5 months postbaseline. Eligible participants included patients with newly diagnosed multiple myeloma treated at community oncology practices or academic medical centers in the US. GP5 response options were "very much," "quite a bit," "somewhat," "a little bit," and "not at all." Responses at each assessment while undergoing treatment (1 month, 2.8 months, and 5.5 months) were categorized as high adverse event bother (ie, "very much," and "quite a bit") and low adverse event bother (ie, "somewhat," "a little bit," or "not at all"). In addition, change from baseline to each assessment while undergoing treatment was calculated and categorized as worsening by 1 response category and 2 or more response categories. ETD due to adverse events (yes vs no) was analyzed using logistic regression adjusting for treatment group, performance status, gender, race, and disease stage. Of the 1087 participants in the original trial, 1058 (mean [SD] age 64 [9] years; 531 receiving VrD [50.2%]; 527 receiving KRd [49.8%]) responded to item GP5 and were included in the secondary analysis. A small proportion (142 patients [13.4%]) discontinued treatment early due to AEs. For those with high adverse-effect bother, GP5 while undergoing treatment was associated with ETD at 1 month (adjusted odds ratio [aOR], 2.20; 95% CI, 1.25-3.89), 2.8 months (aOR, 3.41; 95% CI, 2.01-5.80), and 5.5 months (aOR, 4.66; 95% CI, 1.69-12.83). Worsening by 2 or more response categories on the GP5 was associated with ETD at 2.8 months (aOR, 3.02; 95% CI, 1.64-5.54) and 5.5 months (aOR, 5.49; 95% CI, 1.45-20.76). In this survey study of the E1A11 trial, worse GP5 response was associated with ETD. These findings suggest that simple assessment of adverse-effect bother while receiving treatment is an efficient way to indicate treatment tolerability and ETD risk.

A Biomarker of Stress and Self-reported Caregiving Distress Predict Poor Quality of Life in Family Caregivers of Patients With Heart Failure.

Family caregivers are at a high risk for low quality of life due to caregiving-related stress. Caregivers' stress is commonly assessed using self-reported measures, which reflect relatively subjective and long-term stress related to caregiving, but objective biological markers of stress are rarely used for caregivers. The purposes of this study were (1) to determine whether caregiver characteristics were associated with stress assessed using a stress biomarker (serum cortisol) and a self-reported caregiving distress measure (Caregiver Burden Inventory) and (2) to determine the predictability of both stress measures for quality of life in caregivers of patients with heart failure. Taiwanese family caregivers (N = 113; mean age, 54.5 years; 70.8% female) of patients with heart failure completed surveys including caregiving distress and quality of life measured by the Caregiver Burden Inventory and the Short Form-36 (physical and psychological well-being subscales), respectively, and provided blood samples for serum cortisol. Independent t tests, correlation, and hierarchical regression were conducted. Single caregivers had higher serum cortisol levels than married caregivers (P = .002). Men had significantly higher serum cortisol levels than women (P = .010), but men reported lower caregiving distress than women (P = .049). Both serum cortisol (β = -0.32, P = .012) and caregiving distress (β = -0.29, P = .018) were significant predictors of quality of life in the physical well-being scale while controlling for caregivers' characteristics and depressive symptoms. Serum cortisol (β = -0.28, P = .026) and caregiving distress (β = -0.25, P = .027) also predicted quality of life in the psychological well-being scale. Serum cortisol and self-reported caregiving distress have similar predictability for quality of life in family caregivers of patients with heart failure. Reducing stress and caregiving distress is critical to improving quality of life in this population.

Quality of life and psychological distress of patients with advanced cancer in the Philippines.

This study aimed to describe the quality of life (QOL) and psychological distress (anxiety and depression) of Filipino patients with advanced solid cancers and identify sociodemographic and clinical-related factors associated with them. 195 patients with advanced cancer were recruited from a major hospital treating cancer patients in the Philippines. Participants completed self-reported surveys on Quality-of-life (QOL-FACT-G) and psychological distress (HADS-D, HADS-A). Multi-variable OLS regression models were performed where sociodemographic, health history and clinical characteristics were included as predictors. The average total FACT-G score was 65.39/108 (Standard deviation (SD) = 13.76), with the physical well-being scale having the lowest scores (M = 14.14/28, SD = 5.92). The two most common symptoms reported were fatigue (88%) and pain (86.5%). Physical symptom burden was significantly negatively associated with QOL and psychological distress. The average HADS-total score was 14.46/21 (SD = 5.77), with 8% with probable anxiety and 27% with probable depression. Participants who reported greater reliance on their spiritual faith for strength in coping with illness reported lower depression scores. Our findings underline the importance of understanding the multi-dimensional outcomes of Filipino advanced cancer patients. Results may be used to improve QOL and reduce the psychological distress of advanced cancer patients.

Patient-reported outcome measures for physical function in cancer patients: content comparison of the EORTC CAT Core, EORTC QLQ-C30, SF-36, FACT-G, and PROMIS measures using the International Classification of Functioning, Disability and Health

BackgroundPatient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients.MethodsRelying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers.ResultsThe 118 items investigated were assigned to 3 components (‘d – Activities and Participation’, ‘b – Body Functions’, and ‘e – Environmental Factors’) and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories ‘d4 – Mobility’ and ‘d5 – Self-care’, all within the component ‘d – Activities and Participation’. The SF-36 additionally included item content related to ‘d9 – Community, social and civic life’ and the PROMIS Short Form for Physical Function 20a also included content related to ‘d6 – domestic life’. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component ‘b – Body Functions’. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework.DiscussionOur results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.

Physical well-being among traffic-police impact analysis due to noise

Aim: The aim and objective of this research were to identify the noise effect on the physical well-being of traffic police. Methods: The data for the current study was gathered using a systematic questionnaire and interview schedule, which includes a general profile, working profile, health profile, and the Physical Well-Being Scale was used, body discomfort & intensity of pain which include body discomfort 8 questions and intensity of pain 10 questions) A sample of 60 respondents aged between 25-65 years. Results: There is no significant difference between noise level and physical well-being but still the noise level has a great effect on them. Conclusions: A traffic Police are extremely stressful. They must work in extremely uncomfortable conditions such as long working hours and standing positions. Traffic cops work in hazardous conditions with low physical well-being. It was determined that physical well-being among traffic officers may be caused by long working hours, job experience, and age.

Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia

IntroductionPatient-reported outcomes (PROs) predict overall survival (OS) in many cancer types, but there is little evidence of their prognostic value in older patients with acute myeloid leukemia (AML). We examined whether the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors among these patients. Materials and MethodsData were from AML2002 (n = 309), a randomized phase 2/3 study comparing decitabine plus talacotuzumab versus decitabine alone in older AML patients ineligible for intensive chemotherapy. We used ridge-penalized Cox proportional hazards models to estimate the association between baseline FACT-Leu scales and OS. We then conducted a bootstrap analysis to determine how often FACT-Leu scales appeared in forward- and backward- selected “final models” predicting OS relative to prognosticators from the AML Composite Model (AML-CM; e.g., chronic comorbidities, previous cancer, cytogenetic/molecular risk). ResultsIn ridge-penalized models, the FACT-Leu Physical Well-Being (PWB), Trial Outcomes Index (TOI), and Total scales predicted OS. Adjusting for AML-CM factors, an important increase (3 points) in PWB score was associated with a 14% reduction in the hazard of death. In the bootstrap analysis, the PWB scale appeared in 93% of backward- and 98% of forward selected models, while the TOI [57% (backward), 79% (forward)] and FACT-Leu Total [51% (backward), 78% (forward)] appeared less often in final models. Discussion and ConclusionsThese results indicate PROs' value for predicting outcomes among older AML patients and underscore the need to more systematically collect PRO data in routine care with these patients.ClinicalTrials.gov Registration: NCT02472145

Predictors of early hospice or death in patients with inoperable lung cancer treated with curative intent.

e20525 Background: Treatment for inoperable stage II-III non-small cell lung cancer (NSCLC) involves aggressive chemo-radiotherapy (CRT). While outcomes have improved with immunotherapy, some patients transition to hospice or die early in their treatment course. To help identify these patients, we developed a predictive model for early poor outcomes in NSCLC patients treated with curative intent. Methods: In a statewide consortium involving 27 sites, information was collected prospectively on stage II-III NSCLC patients who received curative CRT from April 2012 to November 2019. We defined an early poor outcome as termination of treatment due to hospice enrollment or death within 5 months of initiating radiation therapy. Potential predictors included clinical characteristics and patient reported outcomes (PROs) from validated questionnaires. Logistic regression models were used to assess potential predictors and build predictive models. Multiple imputation was used to handle missing data. We used Lasso regularized logistic regression to build a predictive model with multiple predictor variables. Results: Of the total of 2267 included patients, 128 patients discontinued treatment early due to hospice enrollment or death. The mean age of the 128 patients was 71 years old (range 48-91) and 59% received concurrent chemotherapy. Significant uni-variable predictors of early hospice or death were advanced age, worse ECOG performance status, high PTV volume, short distance to normal tissue critical structures, high mean heart dose, uninsured status, lower scores on the Functional and Physical Well-Being scale and the Lung Cancer Symptoms sub-scale of the FACT-L quality of life instrument, as well as higher levels of patient-reported lack of energy, cough, and shortness of breath. The best predictive model included age, ECOG performance status, PTV volume, mean heart dose, patient insurance status, and patient-reported lack of energy and cough. The pooled estimate of area under the curve (AUC) for this multivariable model was 0.71, with a negative predictive value of 95%, specificity of 97%, positive predictive value of 23%, and sensitivity of 16% at a predicted risk threshold of 20%. Conclusions: Our models identified a combination of clinical variables and PROs that may help identify individuals with inoperable NSCLC undergoing curative intent chemo-radiotherapy who are at a high risk of early hospice enrollment or death. These preliminary results are encouraging and warrant further evaluation in a larger cohort of patients.

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-blinded Randomized Controlled Trial.

Background:Subpectoral tissue expander breast reconstruction is often associated with muscle spasms, pain, and discomfort during tissue expansion. In this study, we hypothesized that an intraoperative injection of botulinum toxin A (BTX-A) in the pectoralis major muscle reduces the pain associated with tissue expansion and improves women’s physical well-being.Methods:Between May 2012 and May 2017, women undergoing immediate subpectoral tissue expander breast reconstruction were randomized to administer 100 units of BTX-A or a placebo injection. A numeric pain intensity scale and the physical well-being scale of the BREAST-Q: Reconstruction Module were used to test our hypothesis. Data on postoperative oral narcotic consumption were not collected.Results:Of the 131 women included in the analysis, 48% were randomized to placebo and 52% to BTX-A. The preoperative median pain intensity score was 0 [interquartile range (IQR), 0–1], and the median preoperative BREAST-Q score was 91 (IQR, 81–100). The median slopes for the change in pain intensity scores from baseline throughout tissue expansion for those randomized to placebo and BTX-A were −0.01 (IQR, −0.02 to 0.00) and −0.01 (IQR, −0.02 to 0.00), respectively (P = 0.55). The median slopes for the change in BREAST-Q scores from baseline throughout tissue expansion for those randomized to placebo and BTX-A were 0.04 (IQR, −0.17 to 0.14) and 0.02 (IQR, −0.06 to 0.13), respectively (P = 0.89).Conclusion:In this study, we found that an intraoperative intramuscular injection of 100 units of BTX-A in the pectoralis major muscle did not reduce postoperative pain and patient-reported physical well-being when compared with placebo.

FACT physical wellbeing to independently predict overall survival in patients with acute myeloid leukemia.

7532 Background: Patient-reported outcomes (PROs) predict overall survival (OS) in solid cancer populations, but little evidence exists around the prognostic value of PROs in patients with hematologic malignancies. We investigated whether scales from the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors. Methods: Data were from 317 AML patients unfit for intensive therapy from a clinical trial comparing Dacogen (decitabine) plus Talacotuzumab versus Dacogen (decitabine) alone (AML2002; NCT02472145). We used ridge-penalized Cox models to determine whether baseline (1st cycle) FACT-Leu scales predicted OS. FACT-Leu scales significant in these models and factors from a validated prognostic model, the AML composite model (AML-CL; covariates listed in Table), were entered into Cox proportional hazard models. Lastly, model selection procedures were run with 1000 bootstrapped samples using all variables. The inclusion frequency of each FACT-Leu scale in the final models was examined to evaluate prognostic value for OS (i.e., higher the % of inclusion, higher importance of the variable). Results: In the ridge-penalized Cox models, the Physical Wellbeing Scale (PWB), Trial Outcome Index (TOI), and FACT-Leu Total scales were significant predictors of OS. After adjusting for the AML-CL factors, an important difference (2 pts) in PWB score was associated with a 9% decline in OS. (Table) Model validity was evidenced as the PWB scale appeared in a large majority of selected models (90%-97%), while the TOI (45%-73%) and FACT-Leu Total (41%-71%) appeared less often. Conclusions: FACT-Leu scales, especially the PWB, were significant prognostic factors for OS among AML patients not suitable for intensive therapy. These results may indicate PROs' value as stratification factors in trials with AML patients and underscore the need to more systematically collect PRO data in routine care practice with AML patients. Clinical trial information: NCT02472145 . [Table: see text]

Phase III randomized controlled trial of eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and advice)—An eHealth intervention during chemotherapy.

7002 Background: Routine monitoring of patients’ symptoms can improve symptom management, quality of life (QOL) and survival. eRAPID is an online system for patients to report symptoms, uniquely providing automated severity-dependent advice (self-management or alerts for hospital contact). We evaluated eRAPID impact on patient experiences & clinical care. Methods: A prospective randomized two-arm parallel group trial (1:1 allocation Usual Care (UC): UC+eRAPID). Eligible patients started chemotherapy for colorectal, breast & gynecological cancers at Leeds Cancer Centre. In eRAPID arm, patients completed weekly online symptoms for 18 weeks. Primary outcome: QOL/symptom control (FACT-PWB Physical Wellbeing Scale) at 18 weeks. Secondary outcomes: process of care (admissions/ chemotherapy delivery), patient self-efficacy (Lorig Self-Efficacy Scale) & global QOL (EQ5D).Mixed effects repeated measures models were employed. Results: During Jan 2015-June 2018, we screened 1484 patients; 508/690 eligible patients (73.6%) consented & were randomized (256 eRAPID:252 UC). No statistically significant effect of eRAPID on FACT-PWB score was found at 18 weeks (difference in means 0.20 95% CI -0.81, 1.20; p = 0.699). There was a positive impactat 6 & 12 weeks (1.08, 95% CI 0.12, 2.05; p = 0.028 & 1.01, 95% CI 0.05, 1.98; p = 0.039).In responder analysis lower proportion of eRAPID patients had clinically meaningful deterioration 47.5% at 12 weeks vs 56.3% UC. Pre-planned subgroup analysis found no effect in metastatic disease, but better FACT-PWB in non-metastatic/adjuvant group at 6 & 12 weeks (1.45, 95% CI 0.32, 2.58; p = 0.011 & 1.13; 95% CI 0.07, 2.19; p = 0.036). eRAPID patients reported better self-efficacy (p = 0.007) & QOL EQ5D-VAS at 12 (p = 0.030) & 18 weeks (p = 0.010). There were no differences for admissions/chemotherapy delivery. 3314 online reports were completed, median per patient 14.0 (range 0-117). Emergency alerts were activated in 29/3314 cases (0.9%), self-management advice 2714/3314 (81.9%). Post-hoc analysesshowed high patient adherence was associated with clinicians’ use of the data, high baseline FACT-PWB & older age. High adherence patients had better FACT-PWB scores at 12 weeks. Conclusions: Online symptom monitoring with immediate advice improved symptom control early during adjuvant chemotherapy (6 &12 weeks), helping patient education & self-efficacy. The results support its utility as an improved model for patient care during adjuvant chemotherapy. Clinical trial information: ISRCTN88520246 .

Quality of life of women with breast cancer undergoing treatment and follow-up at King Salman Armed Forces Hospital in Tabuk, Saudi Arabia.

Background: Assessment of quality of life can significantly impact the diagnosis and treatment course of breast cancer, resulting in a better prognosis among patients. However, very limited data are available regarding quality of life among breast cancer patients in Saudi Arabia.Objective: To determine the quality of life of women with breast cancer referred to the Surgery Department of King Salman Armed Forces Hospital for treatment and follow-up.Materials and methods: This cross-sectional study used a questionnaire to assess the quality of life of 96 adult Saudi female patients diagnosed with breast cancer from January 2016 to September 2017.Results: One-third of the surveyed patients (31.3%) were >48 years of age, and 29.2% were in the 18- to 27-year age group. Regarding marital status, 35.4% of the women were married and 8.3% were single. The highest score was observed for the physical well-being subscale (7.65±071), followed by the spiritual well-being subscale (7.19±0.66), psychological well-being scale (7.09±0.30) and social concerns subscale (7.02±0.41). Age, marital status and cancer stage differed remarkably (P=0.00) for the physical well-being subscale scores. Meanwhile, employed women differed significantly (P=0.01) in terms of psychological well-being compared to those who were not employed. The social well-being subscale score of single and married women was significantly higher than that of widowed and divorced women. Women who underwent radiation and immunotherapy had significantly higher scores for the spiritual well-being subscale.Conclusions: Scores were determined for the physical, spiritual, psychological and social well-being scales. Age, marital status and cancer stage significantly influenced the physical well-being scale; the occupation status of the patients significantly impacted the psychological well-being scale. Social well-being can be predicted by marital status, and chemotherapy and radiation significantly impacted the spiritual well-being scale.

Patients' view of routine follow-up after breast cancer treatment.

SummaryBackgroundTo assess emotional distress, anxiety and stress reactions in breast cancer (BC) patients before the follow-up visits.Study designBetween September 2009 and December 2011 a total of 284 patients completed the BC-psychosocial assessment screening scale (PASS) and a questionnaire about their views of follow-up after treatment for BC.ResultsOf the patients 64% reported low level of distress on the BC-PASS. The mean scores on the physical well-being scale was 5.3, the satisfaction/sense of coherence scale 7.4, and the emotional distress scale 8.1. Women rated mammography as the most important component (71%), followed by breast ultrasound (63%) and the consultation with the physician (60%). Of the patients 94% were satisfied with the current follow-up regimen.ConclusionsIn this series BC patients were satisfied with their aftercare. Mammography was thought to be the most important component of aftercare. Patient-reported outcomes should be taken into account when planning follow-up.

Methodological study to evaluate the psychometric properties of FACIT-CD in a sample of Brazilian women with cervical intraepithelial neoplasia

BackgroundThe occurrence of cervical intraepithelial neoplasia (CIN) is associated with changes in health-related quality of life, including psychological factors, such as fear and shame, and changes in sexuality and sexual satisfaction, such as decreased sexual desire and frequency of sexual intercourse. Personal relationships are the most affected because CIN is sexually transmitted and many women tend to blame their partner for disease transmission. The aim of this study was to evaluate the psychometric properties of the FACIT-CD questionnaire in Brazilian women diagnosed with CIN.MethodsThe properties of the FACIT-CD questionnaire were tested on a sample of 439 women seen at the Department of Prevention of Barretos Cancer Hospital, including 329 patients who were diagnosed with CIN and 110 women who were not diagnosed with the disease. The analysed parameters included internal consistency (Cronbach’s alpha), reproducibility (intraclass correlation coefficient), structural validity, convergent validity (correlation with the SF-12 and EORTC QLQ-CX24 questionnaires), discriminant validity (according to disease status, and self-rating of health), sensitivity, and responsiveness.ResultsThe Cronbach alpha values ​​of the FACIT-CD scales were higher than 0.70 with the exception of the relationship scale (0.66). The FACIT-CD reproducibility was satisfactory, with variation in the intraclass correlation coefficients ranging between 0.50 and 0.83, although the 95% confidence interval (CI) was lower than 0.40 (0.33–0.64) on the treatment satisfaction scale. Regarding structural validity, only one item on the physical well-being scale was not kept in the original domain. The expected correlations between the FACIT-CD and SF-12 were not confirmed, whereas the correlations between the FACIT-CD and EORTC QLQ-CX24 were confirmed. The questionnaire was able to discriminate the groups according to disease status and self-rating of health. The sensitivity was low for the relationship scale and moderate for the other scales. The responsiveness of the FACIT-CD questionnaire varied between the groups that denominate the self-perception of health as no change, improvement or worsening.ConclusionOur results are encouraging and indicate that the FACIT-CD questionnaire is a promising tool for the analysis of the quality of life of women with CIN.

The health-related quality of life journey of gynecologic oncology surgical patients: Implications for the incorporation of patient-reported outcomes into surgical quality metrics

ObjectiveTo report the changes in patient-reported quality of life for women undergoing gynecologic oncology surgeries. MethodsIn a prospective cohort study from 10/2013–10/2014, women were enrolled pre-operatively and completed comprehensive interviews at baseline, 1, 3, and 6months post-operatively. Measures included the disease-specific Functional Assessment of Cancer Therapy-General (FACT-GP), general Patient Reported Outcome Measure Information System (PROMIS) global health and validated measures of anxiety and depression. Bivariate statistics were used to analyze demographic groups and changes in mean scores over time. ResultsOf 231 patients completing baseline interviews, 185 (80%) completed 1-month, 170 (74%) 3-month, and 174 (75%) 6-month interviews. Minimally invasive (n=115, 63%) and laparotomy (n=60, 32%) procedures were performed. Functional wellbeing (20 → 17.6, p<0.0001) decreased at 1-month, and recovered by 3 and 6months. Emotional wellbeing increased (16.3 → 20.1, p<0.0001) and anxiety decreased (54.2 → 49.0, p<0.0001) at 1-month, and were stable at 3 and 6months. Physical wellbeing scales were not sensitive to surgery. These patterns were consistent across procedure type, cancer diagnosis, and adjuvant therapy administration. In an exploratory analysis of the interaction of QOL and quality, patients with increased postoperative healthcare resource use were noted to have higher baseline levels of anxiety. ConclusionsFor women undergoing gynecologic oncology procedures, temporary declines in functional wellbeing are balanced by improvements in emotional wellbeing and decreased anxiety symptoms after surgery. Not all commonly used QOL surveys are sensitive to changes during the perioperative period and may not be suitable for use in surgical quality metrics.

Emotional acceptance, inflammation, and sickness symptoms across the first two years following breast cancer diagnosis

PurposeBreast cancer diagnosis and treatment are associated with increased inflammatory activity, which can induce sickness symptoms. We examined whether emotional acceptance moderates the association between proinflammatory cytokines and self-reported sickness symptoms in women recently diagnosed with breast cancer. MethodsWomen (N=136) diagnosed with stage 0-III breast cancer within the previous 6months provided plasma samples and completed the FACT: Physical Well-Being Scale, as well as the Acceptance of Emotion Scale every 3months for 2years. At each time point, we quantified interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor (TNF)-α using a high sensitivity multiplex assay. ResultsHigher within-subject mean TNF-α across all time-points predicted higher mean sickness symptoms. At individual time-points, higher IL-6 and IL-8 levels were associated with higher sickness symptoms. Mean emotional acceptance across all time-points moderated the relationship between mean IL-8 and sickness symptoms, with sickness symptoms remaining persistently high in women with low emotional acceptance even when IL-8 levels were low. At individual time-points, emotional acceptance positively moderated the correlations of IL-8 and TNF-α with sickness symptoms, such that the associations between higher levels of these proinflammatory cytokines and higher sickness symptoms were attenuated when emotional acceptance was high. ConclusionEmotional acceptance was shown for the first time to moderate the associations of cytokines with sickness symptoms in breast cancer patients over time following diagnosis and treatment. The association between emotional acceptance and sickness symptoms was significantly different from zero but relatively small in comparison to the range of sickness symptoms. Results suggest that targeting emotion regulation may help to break the cycle between inflammation and sickness symptoms in women with breast cancer.

Prognostic value of health-related quality of life on survival in patients diagnosed with hepatocarcinoma carcinoma

4643 Background: Accumulating evidence suggests that health related quality of life (HRQL) is prognostic of survival across several disease types, including cancer. The aims of the present study were to (1) assess the prognostic value of HRQL with a disease-specific instrument, and (2) explore linear and non-linear associations between HRQL and survival in patients diagnosed with unresectable hepatocellular carcinoma. Methods: A prospective study study of 166 patients diagnosed with hepatobiliary carcinoma and referred for treatment were administered the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) to assess HRQL. Survival was measured from diagnosis to death. Results: Using Cox regression and Kaplan Meier survival analyses, baseline overall HRQL (p=0.05) and the physical well-being scale (p=0.04) was found to significantly predict survival while controlling for sociodemographic (i.e., age) and disease- specific variables (i.e., etiology, tumor size, number of lesions, vascular invasion, alpha-fetoprotein, bilirubin, prothrombin time). A linear association between overall HRQL and survival was observed with patients reporting overall HRQL scores in the highest tertile having a mean survival of 19.4 months, the middle tertile with a mean survival of 17.6 months, and the lowest tertile having a mean survival of 17.2 months. A similar trend in mean survival was found for patients who reported physical well being in the highest tertile (15 months), middle tertile (11 months), and lowest tertile (5 months) of this subscale. The disease-specific module of the FACT-Hep was not found to significantly predict survival, however a robust trend was revealed (p=0.06). Conclusion: Overall HQRL and the physical well-being scale were found to be prognostic for patients with HCC. A linear relationship was found between HRQL and survival and a robust trend was found in regard to the association between the disease-specific module of the FACT-Hep and survival. With accumulating evidence regarding the prognostic value of HRQL, stratification of patients in clinical trials based on baseline HRQL may be recommended. HRQL may represent an important element in new prognostic systems for HCC. No significant financial relationships to disclose.