Jeffrey W. Janata

The Utian Quality of Life (UQOL) Scale: Development and validation of an instrument to quantify quality of life through and beyond menopause

ObjectiveQuality of life (QOL) is an outcome variable requiring measurement in clinical care or pivotal regulatory trial research. Current menopause QOL measures are mostly life phase or disease symptom inventories or scores. Believing that QOL should refer more to “sense of well-being,” we have developed the Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. DesignA pool of items sampling various aspects of well-being was developed. Peri- and postmenopausal women (n = 327) responded to the items, and their responses were subjected to a factor analysis. Four factors emerged, each representing a QOL domain. The resulting 23-item instrument was validated in a geographically and socioeconomically diverse sample of peri- and postmenopausal women using the Short Form-36, an established, frequently used QOL inventory. QOL domains were subjected to confirmatory factor analyses, formal item analysis was completed, and the measure was assessed for reliability and validity, including a second sample of women (n = 270). ResultsWomen (n = 597; mean age, 52.9 years) from 12 communities across the United States completed the measure. The UQOL seems to reflect four components of QOL: occupational QOL, health QOL, emotional QOL, and sexual QOL. The questionnaire and scoring system are presented. ConclusionWe are reporting on the process of validating an instrument for quantifying sense of well-being in a perimenopausal population. Substantial reliability and validity estimates for the scale and its subscales support the UQOL as a valuable new tool for use in clinical research and practice.

Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): A randomized controlled trial

OBJECTIVE The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to evaluate an intervention for ECS to promote weight loss and a healthy lifestyle. METHODS Early stage overweight and obese (body mass index ≥ 25) ECS (N=75) were randomized to a 6-month lifestyle intervention (LI) or usual care (UC). The LI group received education and counseling for six months (10 weekly followed by 6 bi-weekly sessions). Weight change at 12 months was the primary endpoint. Secondary outcomes included fruit/vegetable servings/day and physical activity (PA). Multiple imputations were used for missing data and mixed models were used to analyze changes from baseline. RESULTS Adherence was 84% and follow-up data were available from 92% of participants at 6 months and 79% at 12 months. Mean [95% CI] difference in weight change between LI and UC groups at 6 months was -4.4 kg [-5.3, -3.5], p<0.001 and at 12 months was -4.6 kg [-5.8, -3.5], p<0.001. Mean [95% CI] difference in PA minutes between groups at 6 months was 100 [6, 194], p=0.038 and at 12 months was 89 [14, 163], p=0.020. Mean difference in kilocalories consumed was -217.8 (p<0.001) at 6 months and -187.2 (p<0.001) at 12 months. Mean [95% CI] difference in fruit and vegetable servings was 0.91 servings/day at 6 months and 0.92 at 12 months (p<0.001). CONCLUSIONS Behavior change and weight loss are achievable in overweight and obese ECS, however, the clinical implications of these changes are unknown and require a larger trial with longer follow-up.

A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change

BackgroundTo examine the effects of a 6 month lifestyle intervention on quality of life, depression, self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors.MethodsEarly stage endometrial cancer survivors were randomized to intervention (n = 23) or usual care (n = 22) groups. Chi-square, Students t-test and repeated measures analysis of variance were used in intent-to-treat analyses. Outcomes were also examined according to weight loss.ResultsMorbidly obese patients had significantly lower self-efficacy, specifically when feeling physical discomfort. There was a significant improvement for self-efficacy related to social pressure (p = .03) and restraint (p = .02) in the LI group. There was a significant difference for emotional well-being quality of life (p = .02), self-efficacy related to negative emotions (p < .01), food availability (p = .03), and physical discomfort (p = .01) in women who lost weight as compared to women who gained weight. Improvement in restraint was also reported in women who lost weight (p < .01).ConclusionThis pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors.Trial Registrationhttp://www.clinicaltrials.gov; NCT00420979

Lifestyle challenges in endometrial cancer survivorship.

OBJECTIVE: To examine lifestyle behaviors that may contribute to endometrial cancer survivor morbidity and to identify associations with quality of life. METHODS: Patients with early-stage (I or II) endometrial cancer with a body mass index of at least 25 kg/m2 completed questionnaires on smoking, physical activity, fruit and vegetable intake, and the Functional Assessment of Cancer Therapy (FACT) and Short-Form medical outcomes (SF-36) quality-of-life surveys. Behaviors were compared with American Cancer Society 2006 guidelines for cancer survivors (150 min/wk of moderate-to-vigorous physical activity; five servings fruit and vegetables per day; no smoking). Effect size (d) was calculated for the difference in means between meeting and not meeting guidelines (d=0.5 moderate effect). RESULTS: A total of 120 participants were enrolled. Of those, 43% had hypertension, 35% osteoarthritis, 33% metabolic syndrome, 21% type 2 diabetes mellitus, and 93% abdominal obesity. Only 12% of participants were meeting physical activity guidelines. Fifteen percent reported five or more servings of fruit and vegetables per day; mean intake was 2.6 servings per day. Seventy-four percent of participants were nonsmokers. Only 1% of participants met all three American Cancer Society guidelines; 22% met none of the recommendations. The emotional well-being (mean 17.4 [±4.1] compared with 20.1 [±4.1]; d=0.66) and fatigue scores (mean 34.6 [±9.5] compared with 40.5 [±9.6]; d=0.62) indicate that those who do not meet the guidelines had lower emotional well-being and increased fatigue. CONCLUSION: Endometrial cancer survivors have unhealthy lifestyles that put them at risk for morbidity. This survivor group should be offered multi-behavioral lifestyle interventions after diagnosis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT 00420979 and NCT00732173. LEVEL OF EVIDENCE: II

The use of systematic desensitization to overcome resistance to magnetic resonance imaging (MRI) scanning

The use of behavioral techniques with radiologic procedures has received surprisingly little attention in the behavioral literature. The current paper describes the successful use of systematic desensitization to enable a woman to complete a magnetic resonance imaging (MRI) scan. Suggestions for when behavior therapy may be useful to radiologists are also given.

Specificity of Anhedonic Depression and Anxious Arousal with Sexual Problems Among Sexually Healthy Young Adults

INTRODUCTION Past research has suggested that depression and anxiety are similarly associated with sexual problems. However, methodological limitations may have hindered the ability of prior studies to detect potential specificity between depression and anxiety with distinct sexual problems. Specifically, previous studies have frequently used measures that confound depression and anxiety, focused exclusively on populations with medical complications, and failed to account for the iatrogenic effects of antidepressants. AIM Clark and Watsons tripartite model was used to differentiate anxious and depressive symptoms and examine their associations with indices of sexual functioning. Specifically, we examined how general distress, anxious arousal, and anhedonia are differentially related to sexual desire, arousal, erection and lubrication difficulties, orgasm achievement, pain, satisfaction, avoidance, pleasure, concerns, and sexual self-image. METHODS In a cross-sectional study, 1,258 young men and women completed the Female Sexual Function Index, Male Sexual Function Index (adapted for the current investigation), Profile of Female Sexual Function, and Mood and Anxiety Symptom Questionnaire. RESULTS Zero-order correlations revealed some specificity between the three affective constructs, as they were associated with sexual problems. However, multiple regression analyses revealed clearer patterns, showing that anhedonic depression was more uniquely related to most sexual problems among women, whereas the relations of anxiety and depression with male sexual problems were more mixed. DISCUSSION This study of young subjects not identified to have affective or sexual disorders suggests that specificity exists between depression and anxiety as they relate to sexual functioning, and that this specificity varies between genders. Such findings highlight the importance of considering the unique influences of anxiety and depression in the conceptualization and treatment of sexual dysfunction.

Fear of nausea and vomiting: The interaction among psychosocial stressors, development transitions, and adventitious reinforcement

This paper describes the treatment of a relatively unreported syndrome, fear of nausea and vomiting in children and adolescents. For all subjects, the symptoms began shortly after an illess or hospitalization that included nausea as a symptom. Treatment consisted primarily of changing parental response to symptomatic behavior. The possible interaction among developmental transitions, psychosocial stressors, and reinforcement in the etiology of this disorder is discussed. It is suggested that life stresses may make children more vulnerable to adventitious reinforcement of symptoms.

Effect of raloxifene on quality of life: a prospective study using the Utian Quality of Life (UQOL) Scale.

Objective:The Utian Quality of Life Scale (UQOL) is a new questionnaire used to quantify patient perception of quality of life in postmenopausal women. The current study is the first to use the UQOL in ascertaining treatment effects on quality of life in postmenopausal women. Design:This was a randomized, double-blind, placebo-controlled study of healthy postmenopausal women. Participants were randomized to raloxifene 60 mg/day or placebo. Participants completed the UQOL at baseline, at 3 months, and at the 6-month study endpoint. Results:A total of 74 women (mean age, 55.6 years) were randomized. In the overall population, there were no significant changes from baseline to 6 months within or between treatment groups in any of the domains or total score, although raloxifene was associated with positive changes from baseline in the occupational (P = 0.093) and health (P = 0.055) domains. In women who completed the study, raloxifene was associated with a significant improvement from baseline in the occupational (P = 0.041) and health (P = 0.025) domains and in the total score (P = 0.044), whereas placebo had no effect. There were no statistically significant differences between raloxifene and placebo in any of the domains or total score. Conclusion:Although there were no treatment group differences, raloxifene was associated with an improvement from baseline in the occupational and health domains and in the overall score of the UQOL. Larger studies are needed using the UQOL as a primary endpoint to determine whether the positive effects of raloxifene on quality of life observed in this trial are real or a chance finding.

Chronic Regional Pain Syndrome: What Specialized Rehabilitation Services Do Patients Require?

Chronic regional pain syndrome (CRPS) is a complex disorder, the optimal treatment of which requires an interdisciplinary approach encompassing medical, interventional, psychological, and rehabilitation services that emphasize the role of physical and occupational therapies. The central focus of treatment is the restoration of function, utilizing a systematic, coordinated, and progressive set of therapeutic strategies. The poorly delineated pathophysiology and variable course of CRPS suggest that individualized strategies are required for optimal management, but also mean that carefully controlled trials of physiotherapy are difficult to conduct. This article presents a brief review of the nature and pathophysiology of CRPS, the medical and psychological approaches that have been found to be effective, and a review of the current trends in rehabilitation.

The primary practice physician program for chronic pain (© 4PCP): outcomes of a primary physician-pain specialist collaboration for community-based training and support.

Objectives:One in 3 patients sees a primary care physician (PCP) for chronic pain yet most PCPs receive no training in this field. We evaluated the impact of 4PCP (© Primary Practice Physician Program for Chronic Pain) comprising of a specialist-PCP training collaboration integrated with clinical support. Methods:This prospective, controlled pilot study randomly assigned 31 physicians to receive a training program either immediately or after a 1-year control period. 4PCP includes: (1) an active learning arm, providing patient-focused, practice-based learning collaboration emphasizing the biopsychosocial pain model; (2) a PCP-led clinical support arm facilitating rehabilitative matrix style care by teams of pain-informed health providers. Main outcome measures included a 19-item chronic pain physician perspectives questionnaire, physician engagement through continuing medical education hours earned, and an array of established measures of patient pain and function. Results:PCPs receiving the intervention reported improvements in diagnosing and managing chronic pain (P=0.023), especially its functional consequences (P=0.008), in treatment satisfaction, and in involving other disciplines. Mean visit time dropped from 20 to 11 minutes (P<0.03) with improved patient outcomes, which correlated with 4PCP physician engagement. Significant benefit began at 10 continuing medical education hours and proved durable 1 year after trial. Discussion:This pilot study demonstrates successful interdisciplinary chronic pain management by PCPs with durability of training effect, improved patient outcomes, visit efficiency, and job satisfaction. 4PCP provides a promising framework to propel the national concept of PCP-specialist collaboration for chronic pain management.