Intensity-Modulated Radiation Therapy Reduces Patient-Reported Chronic Toxicity Compared With Conventional Pelvic Radiation Therapy: Updated Results of a Phase III Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The purpose of this update was to determine differences in patient-reported chronic toxicity and disease outcomes with intensity-modulated radiation therapy (IMRT) compared with conventional pelvic radiation. Patients with cervical and endometrial cancers who received postoperative pelvic radiation were randomly assigned to conventional radiation therapy (CRT) or IMRT. Toxicity and quality of life were assessed using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary domains, and Functional Assessment of Cancer Therapy-General. Between 2012 and 2015, 279 eligible patients were enrolled to the study with a median follow-up of 37.8 months. There were no differences in overall survival (P = .53), disease-free survival (P = .21), or locoregional failure (P = .81). One year after RT, patients in the CRT arm experienced more high-level diarrhea frequency (5.8% IMRT v 15.1% CRT, P = .042) and a greater number had to take antidiarrheal medication two or more times a day (1.2% IMRT v 8.6% CRT, P = .036). At 3 years, women in the CRT arm reported a decline in urinary function, whereas the IMRT arm continued to improve (mean change in EPIC urinary score = 0.5, standard deviation = 13.0, IMRT v -6.0, standard deviation = 14.3, CRT, P = .005). In conclusion, IMRT reduces patient-reported chronic GI and urinary toxicity with no difference in treatment efficacy at 3 years.

Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study.

PURPOSE: In oncology trials, the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is the standard tool for reporting adverse events (AEs), but it may underreport symptoms experienced by patients. This analysis of the NRG Oncology RTOG 1203 compared symptom reporting by patients and clinicians during radiotherapy (RT). PATIENTS AND METHODS: Patients with cervical or endometrial cancer requiring postoperative RT were randomly assigned to standard 4-field RT or intensity-modulated RT (IMRT). Patients completed the 6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence at various time points. Patients reported symptoms on a 5-point scale. Clinicians recorded these AEs as CTCAE grades 1 to 5. Clinician- and patient-reported AEs were compared using McNemar's test for rates > 0%. RESULTS: Of 278 eligible patients, 234 consented and completed the PRO-CTCAE. Patients reported high-grade abdominal pain 19.1% (P < .0001), high-grade diarrhea 38.5% (P < .0001), and fecal incontinence 6.8% more frequently than clinicians. Similar effects were seen between grade ≥ 1 CTCAE toxicity and any-grade patient-reported toxicity. Between-arm comparison of patient-reported high-grade AEs revealed that at 5 weeks of RT, patients who received IMRT experienced fewer GI AEs than patients who received 4-field pelvic RT with regard to frequency of diarrhea (18.2% difference; P = .01), frequency of fecal incontinence (8.2% difference; P = .01), and interference of fecal incontinence (8.5% difference; P = .04). CONCLUSION: Patient-reported AEs showed a reduction in symptoms with IMRT compared with standard RT, whereas clinician-reported AEs revealed no difference. Clinicians also underreported symptomatic GI AEs compared with patients. This suggests that patient-reported symptomatic AEs are important to assess in this disease setting.

Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy.

OBJECTIVE: Women with endometrial or cervical cancer at risk for recurrence receive postoperative radiation therapy (RT). A patient reported outcomes (PRO) instrument to assess bowel and urinary toxicities is the Expanded Prostate Cancer Index Composite (EPIC), which has been validated in men with prostate cancer. As this instrument specifically measures bowel toxicity and the degree to which this is a problem, it was used in NRG Oncology/RTOG 1203 to compare intensity modulated RT (IMRT) to standard RT. This paper reports on the expanded validation of EPIC for use in women receiving pelvic RT. METHODS: In addition to the EPIC bowel domain, urinary toxicity (EPIC urinary domain), patient reported bowel toxicities (PRO-CTCAE) and quality of life (Functional Assessment of Cancer Therapy (FACT)) were completed before, during and after treatment. Sensitivity, reliability and concurrent validity were assessed. RESULTS: Mean bowel and urinary scores among 278 women enrolled were significantly worse during treatment and differed between groups. Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline. Correlations between function and bother scores within the bowel and urinary domains were consistently stronger than those across domains. Correlations between bowel domain scores and PRO-CTCAE during treatment were stronger than those with the FACT. CONCLUSION: Correlations within and among the instruments indicate EPIC bowel and urinary domains are measuring conceptually discrete components of health. These EPIC domains are valid, reliable and sensitive instruments to measure PRO among women undergoing pelvic radiation.

Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology-RTOG 1203.

Purpose NRG Oncology/RTOG 1203 was designed to compare patient-reported acute toxicity and health-related quality of life during treatment with standard pelvic radiation or intensity-modulated radiation therapy (IMRT) in women with cervical and endometrial cancer. Methods Patients were randomly assigned to standard four-field radiation therapy (RT) or IMRT radiation treatment. The primary end point was change in patient-reported acute GI toxicity from baseline to the end of RT, measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC). Secondary end points included change in patient-reported urinary toxicity, change in GI toxicity measured with the Patient-Reported Outcome Common Terminology Criteria for Adverse Events, and quality of life measured with the Trial Outcome Index. Results From 2012 to 2015, 289 patients were enrolled, of whom 278 were eligible. Between baseline and end of RT, the mean EPIC bowel score declined 23.6 points in the standard RT group and 18.6 points in the IMRT group ( P = .048), the mean EPIC urinary score declined 10.4 points in the standard RT group and 5.6 points in the IMRT group ( P = .03), and the mean Trial Outcome Index score declined 12.8 points in the standard RT group and 8.8 points in the IMRT group ( P = .06). At the end of RT, 51.9% of women who received standard RT and 33.7% who received IMRT reported frequent or almost constant diarrhea ( P = .01), and more patients who received standard RT were taking antidiarrheal medications four or more times daily (20.4% v 7.8%; P = .04). Conclusion Pelvic IMRT was associated with significantly less GI and urinary toxicity than standard RT from the patient's perspective.

Validation study of a pooled electronic healthcare database: the effect of obesity on the revision rate of total knee arthroplasty.

The objective of this study was to validate the use of a software platform (Explorys, Inc., Cleveland, OH) by determining whether the association observed between obesity and revision of total knee arthroplasty (TKA) was obtained within this database. Risk of revision in cohorts with a BMI > 30, as well as cohorts with a BMI between 30-35, 35-40 and >40 was compared to patients with a BMI between 18 and 30 (relative risk, RR). Risk in men versus women was examined. From this database, 70,070 patients were identified that had undergone a TKA. Risk of revision increased as a function of BMI; RR achieved significance in the following cohorts: all patients with a BMI > 30, all patients with a BMI > 40, men with a BMI > 30 and men with a BMI > 40. All other subgroups showed increased RR but did not reach significance. In obese patients, RR was greater in men than in women, and the effect was significant in all groups examined except patients with a BMI between 35 and 40. Data from this study contribute to the process of demonstrating the Explorys software platform is a valid and useful method to investigate associations across large populations.

Training to maintain surgical skills during periods of robotic surgery inactivity.

BACKGROUND: The study was performed to establish a level of practice needed for newly-trained residents to maintain robotic surgical skills during periods of robotic inactivity. METHODS: Ten surgical residents were trained to a standardized level of robotic surgery proficiency with inanimate models. At the end of two, four and six weeks, the residents practiced with the models for a total of one hour. Each resident performed a timed tissue closure task immediately after reaching the proficiency standards and twice in succession at eight weeks. Time to completion was compared between the three trials with a repeated measures ANOVA and a post-hoc test. RESULTS: Average time to complete the tissue closure task decreased by more than 25% over the period between reaching the proficiency standards and the trials at eight weeks, with the difference significant (P < 0.004). CONCLUSIONS: Biweekly practice for one hour was sufficient to maintain robotic surgical skills.

Using virtual reality to maintain surgical skills during periods of robotic surgery inactivity.

Periodic practice is needed for newly trained robotic surgeons to maintain skills during periods of robotic inactivity. The current study was performed to determine whether virtual robotic skill maintenance can serve as an adequate substitute for practice on a surgical robot. Eleven surgical residents with no prior robotic training were trained to a level of robotic proficiency with inanimate models, including a needle driving pad, a running suture pad, and ring placement on a rocking peg board. After reaching proficiency, each resident was tested on a complex tissue closure task. For the next 8 weeks, the only robotic activity was biweekly virtual robotic skills maintenance. After 8 weeks, the residents performed the tissue closure task twice with the robot, followed by evaluation on the inanimate models used to reach proficiency. Repeated-measures statistical analyses were used to compare between the three tissue closure trials and between the final test at week 0 and the evaluation at week 8 for the other inanimate models. Time to complete the tissue closure task was more than 20 % lower for the second evaluation at 8 weeks than for the other two trials (p < 0.05). Residents maintained their skills for needle driving, but times for suture running and rocking peg board increased by more than 20 % at 8 weeks (p < 0.01). Virtual practice shows promise for maintaining robotic skills. Following a warm-up period, some skills may actually improve with biweekly virtual practice, but skill retention is selective, so further improvements are needed.

Outcomes of an uncertainty management intervention in younger African American and Caucasian breast cancer survivors.

PURPOSE/OBJECTIVES: To determine whether breast cancer survivors (BCSs) who received an uncertainty management intervention, compared to an attention control condition, would have less uncertainty, better uncertainty management, fewer breast cancer-specific concerns, and more positive psychological outcomes. DESIGN: A 2 × 2 randomized block, repeated-measures design, with data collected at baseline and two other points postintervention, as well as a few days before or after either a mammogram or oncologist visit. SETTING: Rural and urban clinical and community settings. SAMPLE: 313 female BCSs aged 50 or younger; 117 African Americans and 196 Caucasians. METHODS: Participants were blocked on ethnicity and randomly assigned to intervention or control. The intervention, consisting of a scripted CD and a guide booklet, was supplemented by four scripted, 20-minute weekly training calls conducted by nurse interventionists. The control group received the four scripted, 20-minute weekly training calls. MAIN RESEARCH VARIABLES: Uncertainty in illness, uncertainty management, breast cancer-specific concerns, and positive psychological outcomes. FINDINGS: BCSs who received the intervention reported reductions in uncertainty and significant improvements in behavioral and cognitive coping strategies to manage uncertainty, self-efficacy, and sexual dysfunction. CONCLUSIONS: The intervention was effective as delivered in managing uncertainties related to being a younger BCS. IMPLICATIONS FOR NURSING: The intervention can realistically be applied in practice because of its efficient and cost-effective nature requiring minimal direct caregiver involvement. The intervention allows survivors who are having a particular survival issue at any given point in time to access information, resources, and management strategies. KNOWLEDGE TRANSLATION: Materials tested in CD and guide booklet format could be translated into online format for survivors to access as issues arise during increasingly lengthy survivorship periods. Materials could be downloaded to a variety of electronic devices, fitting with the information needs and management styles of younger BCSs.

Endometrial cancer survivors' assessment of the benefits of exercise.

OBJECTIVE: The majority of women who have had endometrial cancer remain at risk for obesity related diseases. The social cognitive theory was used to explore their beliefs about exercise to aid in the development of effective interventions. METHODS: Women who had been treated for Stage I endometrial cancer were asked about their level of exercise to determine if they had been exercising regularly for more than 6 months (exercisers vs non-exercisers). They were asked to rate the likelihood that exercise would result in various health outcomes (expectations) and to rate the importance of these outcomes (expectancies). Scores for how likely exercise would result in an outcome of importance were calculated. Height and weight were obtained from nurses for calculation of BMI. Statistics were conducted using SPSS v 15. RESULTS: There were 106 valid questionnaires (86% participation rate); 41% were exercisers. Mean BMI was significantly lower in exercisers (31.6 ± 1.2 vs. 37.3 ± 1.2, p=0.001); a significantly greater proportion reported not having diabetes, heart disease or hypertension (69.8% vs. 49.2%, p=0.035). Exercisers were significantly more likely to report that feeling better physically and emotionally versus reducing the risk of diseases were likely and important outcomes of exercise (18.2 ± 0.8 vs 15.0 ± 1.0, p=0.002). CONCLUSIONS: Exercisers identified outcomes of exercise that are more immediate and subjective as being important and likely outcomes of exercise. Focusing on these aspects of exercise (feeling better physically and emotionally) may aid in the development of effective interventions for non-exercisers.

The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study.

PURPOSE: To explore the association between baseline quality of life (QOL) scores and overall survival (OS) in ovarian cancer patients receiving adjuvant chemotherapy. METHODS: Patients with stage III ovarian cancer on Gynecologic Oncology Group protocol #172 completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were then randomly assigned to either intravenous (IV) or intraperitoneal (IP) chemotherapy. The FACT scale includes physical, functional, social, and emotional well-being domains (PWB, FWB, SWB, EWB). The PWB item, lack of energy, was used to assess the presence of fatigue. RESULTS: After adjusting for patient age, treatment assignment, and the presence of gross disease, PWB was associated with OS. Patients who reported baseline PWB scores in the lowest 25% (PWB score<15 points) relative to those who scored in the highest 25% (PWB score>24 points) had decreased OS (HR: 1.81; 95% CI: 1.2-2.72; p=0.005). Patients experienced death rates 20% lower for every mean item point increase in PWB (Hazard Ratio [HR]: 0.80; 95% CI: 0.68-0.93; p=0.005). Patients complaining of fatigue did not have an increased risk of death compared with those not feeling fatigued (HR: 1.21; 95% CI: 0.91-1.61; p=0.19). CONCLUSIONS: Poor physical well-being reported at baseline is associated with risk of death in patients undergoing adjuvant chemotherapy for advanced ovarian cancer. Identifying modifiable characteristics that are associated with survival offers the potential for providing support that may improve outcomes.

Robotic surgical skills: acquisition, maintenance, and degradation.

BACKGROUND AND OBJECTIVES: The degradation in robotic skills that occurs during periods of robotic surgical inactivity in newly trained surgeons was measured. The role of animate training in robotic skill was also assessed. METHODS: Robotically naive resident and attending surgeons underwent training with the da Vinci robot on needle passage (DN), rocking ring transfer peg board (RPB), and running suture pod tasks (SP). Errors were established to convert actual time to adjusted time. Participants were deemed "proficient" once their adjusted times were within 80% of those set by experienced surgeons through repeated trials. Participants did not use the robot except for repeating the tasks once at 4, 8, and 12 weeks (tests). Participants then underwent animate training and completed a final test within 7 days. RESULTS: Twenty-five attending and 29 resident surgeons enrolled; 3 withdrew. There were significant increases in time to complete each of the tasks, and in errors, by 4 weeks (Adjusted times: DN: 122.9 +/- 2.2 to 204.2 +/- 11.7, t = 6.9, P < .001; RPB: 262.4 +/- 2.5 to 364.7 +/- 8.0, t = 12.4, P < .001; SP: 91.4 +/- 1.4 to 169.9 +/- 6.8, t = 11.3, P < .001). Times decreased following animate training, but not to levels observed after proficiency training for the RPB and SP modules. CONCLUSIONS: Robotic surgical skills degrade significantly within 4 weeks of inactivity in newly trained surgeons. Animate training may provide different skills than those acquired in the dry lab.

Quality of life in endometrial cancer survivors: what does obesity have to do with it?

Objective. Most women with type I endometrial cancer (EC) are obese, increasing the risk of morbidity and mortality in this population. The study objective was to evaluate the impact of obesity on quality of life (QOL) and general health status in EC survivors with early-stage disease. Methods. A prospective ancillary analysis of stage I/II EC survivors. The association of BMI with QOL questionnaire variables measured with the functional assessment of cancer therapy (subscales: physical (PWB), functional (FWB), social, and emotional well-being) and the physical (PCS) and mental component summary subscales of the short-form medical outcomes survey was determined. Results. 152 women completed both questionnaires; 81% were obese. After multiple linear regression, BMI was inversely associated with PWB (P = .001), FWB (P = 0.048), and PCS (P = .001). Conclusions. Despite the good prognosis associated with early-stage EC, QOL, and physical health are not optimized in obese survivors. This paper highlights the importance of incorporating health-related QOL assessments and obesity interventions during the survivorship period.

Physical activity and gynecologic cancer survivorship.

Gynecologic oncology involves the study of preinvasive disease and cancers of the vulva, vagina, cervix, uterus, ovaries, and gestational trophoblastic disease. Endometrial cancer is the most common of the pelvic malignancies however, ovarian cancer is the most lethal. The other gynecologic cancers have not been studied in relation to physical activity (PA) and prognosis, and therefore are not included. Research addressing the relationship between PA and ovarian and endometrial cancer is sparse nevertheless, there are some emerging concepts. Studies suggest that overweight/obesity is associated with reduced survival from ovarian cancer, but the role that PA plays in these results, and whether survival can be altered by changes in body weight and/or PA following diagnosis is unknown. Limited research reveals that increased PA in older ovarian cancer patients is feasible and safe. The majority of endometrial cancer patients are overweight or obese. Obesity is associated with higher mortality, probably from cardiovascular disease and not cancer. Research reveals that increasing PA in overweight/obese endometrial cancers is feasible and successful. The effects of increased PA on recurrence or survival in gynecological cancers are not yet established, and randomized controlled trials are needed for definitive data.

A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study.

CONTEXT: Women diagnosed with ovarian cancer are at risk for reduced quality of life (QOL). It is imperative to further define these declines to interpret treatment outcomes and design appropriate clinical interventions. OBJECTIVES: The primary objective of this study was to compare data obtained from ovarian cancer patients with normative data to assess the degree to which QOL differs from the norm. Secondary objectives were to examine demographic variables and determine if there was a correlation between physical/functional and social/emotional scores during chemotherapy. METHODS: Patients with Stage III/IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent surgery followed by intravenous paclitaxel and cisplatin completed the Functional Assessment of Cancer Therapy-Ovarian. The Functional Assessment of Cancer Therapy scale includes the four domains of physical, functional, social, and emotional well-being (PWB, FWB, SWB, and EWB, respectively). RESULTS: Ovarian cancer patients had a total QOL (Functional Assessment of Cancer Therapy-General) score similar to the U.S. female adult population. However, the reported subscale scores were 2.0 points (95% confidence interval [CI] 1.4-2.5, P<0.001, effect size=0.37) lower in PWB, 0.9 points (95% CI 0.3-1.5, P=0.005, effect size=0.13) lower in FWB, 5.0 points (95% CI 4.6-5.3, P<0.001, effect size=0.74) higher in SWB, and 0.8 points (95% CI 0.3-1.2, P<0.001, effect size=0.16) lower in EWB. Correlation between the sum of PWB and FWB and the sum of SWB and EWB was r=0.53 (P<0.001). Age was positively correlated with EWB (r=0.193; 95% CI 0.09-0.29). CONCLUSION: Ovarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients' QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.

Assessment of factors that contribute to decreased quality of life in Gynecologic Oncology Group ovarian cancer trials.

BACKGROUND: The objective of this study was to assess which quality-of-life (QOL) line items on the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) were associated with low QOL in women who were receiving chemotherapy for ovarian cancer. METHODS: Patients with stage III or IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent primary surgery followed by intravenous paclitaxel and cisplatin completed the FACT-O. The FACT scale includes the 4 domains of physical, functional, social, and emotional well being (PWB, FWB, SWB, EWB, respectively). Women who had overall FACT-O scores in the lowest quartile (Q1) were compared with women in the upper 3 quartiles (Q2-Q4). The proportions of women in each group that selected the 2 worst categories for each item were compared. The level of significance was set at P<.005. RESULTS: Before Cycle 4, 361 patients (86.4%) provided valid QOL assessments. For PWB, a significantly greater proportion of women in Q1 versus Q2 through Q4 selected the 2 worst categories of several physical symptoms (nausea, pain, feeling ill, and being bothered by the side effects of treatment). For FWB, significant differences included being able to work, being content with the quality of their life, and sleeping well. For EWB, there were significant differences in feeling nervous and worrying about dying. There were virtually no differences between groups in SWB. Low interest in sex was reported by 56% to 88% of all patients (Q1-Q4). CONCLUSIONS: A large proportion of women with FACT-O scores in the lowest quartile reported problems that potentially were amenable to clinical interventions, such as symptom management and psychosocial support.

Can sun protection knowledge change behavior in a resistant population?

The future skin cancer statistics for the youth of the United States are staggering. Traditional educational programs are currently the mainstay to foster sun protective awareness for this high-risk, sun-worshipping population. This study was designed to monitor high school students for both short-term and long-term changes in knowledge and attitude, as well as for any change in behavior, following a standard sun protection intervention. Our results demonstrated that although students had an increase in knowledge, it was insufficient to change their behavior.

Successful pregnancy following both endometrial ablation and uterine artery embolization.

OBJECTIVE: To present a description of the management of a pregnancy in a woman who had undergone endometrial ablation and uterine artery embolization for fibroids. DESIGN: Case report. SETTING: Division of Maternal Fetal Medicine within a tertiary community-based teaching hospital. PATIENT(S): A 43-year-old G2P1 woman who had undergone a hydrothermal ballon ablatation and a bilateral, nonselective embolization. INTERVENTION(S): Management of a high-risk pregnancy. MAIN OUTCOME MEASURE(S): Successful pregnancy. RESULT(S): The patient was prophylactically treated with 250 mg of 17 alpha-hydroxyprogesterone intramuscularly weekly, beginning at 16 weeks gestation, received a rescue McDonald cerclage at 22 weeks and 4 days, and remained on modified bed rest at home. Ultrasonically estimated fetal weights were in the 30th to 40th percentile. At 35 4/7th weeks she presented with uterine pain. Ultrasound revealed fundal elevation of the amniotic membranes, estimated fetal weight had decreased to the 20th percentile and a biophysical profile score of 4/10 was obtained. A cesarean resulted in the delivery of a vigorous infant weighing 2466 g. CONCLUSION(S): With aggressive therapy, successful pregnancy is possible in similar patients.

Baseline characteristics influencing quality of life in women undergoing gynecologic oncology surgery.

BACKGROUND: Quality of life (QoL) measurements are important in evaluating cancer treatment outcomes. Factors other than cancer and its treatment may have significant effects on QoL and affect assessment of treatments. Baseline data from longitudinal studies of women with endometrial or ovarian cancer or adnexal mass determined at surgery to be benign were analyzed to determine the degree to which QoL is affected by baseline differences in demographic variables and health. METHODS: This study examined the effect of independent variables on domains of the Functional Assessment of Cancer Therapy (FACT-G) pre-operatively in gynecologic oncology patients undergoing surgery for pelvic mass suspected to be malignant or endometrial cancer. Patients also completed the Short Form Medical Outcomes Survey (SF-36) questionnaire (a generic health questionnaire that measures physical and mental health). Independent variables were surgical diagnosis (ovarian or endometrial cancer, benign mass), age, body mass index (BMI), educational level, marital status, smoking status, physical (PCS) and mental (MCS) summary scores of the SF-36. Multiple regression analysis was used to determine the influence of these variables on FACT-G domain scores (physical, functional, social and emotional well-being). RESULTS: Data were collected on 157 women at their pre-operative visit (33 ovarian cancer, 45 endometrial cancer, 79 determined at surgery to be benign). Mean scores on the FACT-G subscales and SF-36 summary scores did not differ as a function of surgical diagnosis. PCS, MCS, age, and educational level were positively correlated with physical well-being, while increasing BMI was negatively correlated. Functional well-being was positively correlated with PCS and MCS and negatively correlated with BMI. Social well-being was positively correlated with MCS and negatively correlated with BMI and educational level. PCS, MCS and age were positively correlated with emotional well-being. Models that included PCS and MCS accounted for 30 to 44% of the variability in baseline physical, emotional, and functional well-being on the FACT-G. CONCLUSION: At the time of diagnosis and treatment, patients' QoL is affected by inherent characteristics. Assessment of treatment outcome should take into account the effect of these independent variables. As treatment options become more complex, these variables are likely to be of increasing importance in evaluating treatment effects on QoL.

Predicting negative mood state and personal growth in African American and White long-term breast cancer survivors.

BACKGROUND: Relatively little research has examined cognitive processes that may impact psychological adaptation in older long-term breast cancer survivors (BCS). PURPOSE: This study investigated the strength of a conceptual model based on the literature and Uncertainty in Illness Theories which proposes that negative mood state and personal growth in older long-term White and African American BCS would be predicted by the combined influences of demographic and disease variables, social support, religious participation, and cognitive processes (uncertainty, catastrophizing, troublesome thoughts, and cognitive reframing). METHODS: Baseline data were gathered from 524 BCS (369 Whites and 155 African Americans, 5-9 years postdiagnosis) prior to their participating in an uncertainty management intervention program. The conceptual model was tested using structural equation modeling. RESULTS: The multigroup model showed good fit to the data and explained substantial variance in negative mood state and personal growth. Cognitive processes showed both direct and indirect effects on outcomes in the expected directions. Several ethnic differences were found: African Americans were more negatively affected by comorbidities and Whites by symptom distress, whereas cognitive reframing was a stronger predictor of personal growth for African Americans than Whites. CONCLUSIONS: This is one of the first studies to explore predictors of both negative mood and personal growth in a multiethnic sample of BCS. These findings suggest that cognitive processes play an important role in psychological adaptation to breast cancer survivorship. These processes are amenable to change, suggesting a logical target for intervention with this population.