The feasibility and acceptability of a diet and exercise trial in overweight and obese black breast cancer survivors: The Stepping STONE study

PurposeBlack breast cancer survivors have high rates of obesity and low physical activity levels. Little is known about the acceptability and feasibility of interventions in this population.ObjectiveA two-arm RCT was launched to assess the efficacy of a culturally targeted 12-week multimodal lifestyle intervention in overweight and obese black survivors.MethodsIntervention components included nutrition education, exercise groups, and survivor-led motivational interviewing phone sessions. The analytic sample included women who completed the trial (intervention n = 10; control n = 12). Anthropometric measures, physical activity, and VO_2max were assessed at baseline and follow-up. Change scores (intervention vs. control) were assessed with Wilcoxon rank-sum tests. A process evaluation assessed intervention acceptability.ResultsOverall adherence was 70% and overall satisfaction was high (86%). Despite the 5% weight loss target, the intervention group lost 0.8% but BMI improved. Total physical activity levels increased in the intervention vs. control arm (+ 3501 MET min/week vs. + 965 MET min/week, respectively). VO_2max improved in the intervention group (+ 0.10 ± 1.03 kg/L/min). Intervention participants reduced energy intake (− 207.3 ± 31.5 kcals) and showed improvements in fat intake (− 15.5 ± 3.8 g), fiber (+ 3.2 ± 1.2 g) and % energy from fat (− 4.8 ± 3.1%). Survivors suggested providing diet/exercise information within a cancer context.ConclusionsGroup and individualized intervention strategies are acceptable to black survivors. Observed differences between self-report and objective outcomes may suggest reporting bias or changes in body composition. Increasing supervised intervention components and assessment of body composition will be important for future trials.     

Reducing breast cancer recurrence with weight loss,a vanguard trial: The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial

Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is a 4-year randomized clinical trial of 693 overweight/obese women aged ≥ 21 years diagnosed with any early stage breast cancer (stages I[≥ 1 cm]-III) within the previous five years, designed to demonstrate the feasibility of achieving sustained weight loss and to examine the impact of weight loss on quality of life and co-morbidities, and to enable future exploration of biochemical mechanisms linking obesity to lower likelihood of disease-free survival. This trial is strategically designed as a vanguard for a fully-powered trial of women who will be evaluated for breast cancer recurrence and disease-free survival. Participants were recruited between 2010 and 2012 at four sites, had completed initial therapies, and had a body mass index between 25 and 45 kg/m². The intervention featured a group-based cognitive-behavioral weight loss program with telephone counseling and tailored newsletters to support initial weight loss and subsequent maintenance, with the goal of 7% weight loss at two years. This study has high potential to have a major impact on clinical management and outcomes after a breast cancer diagnosis. This trial initiates the effort to establish weight loss support for overweight or obese breast cancer survivors as a new standard of clinical care.     

Evaluating a small change approach to preventing long term weight gain in overweight and obese adults — Study rationale,design, and methods

Despite the rapid rise in obesity worldwide, few strategies have been effective in treating this epidemic. An emerging strategy is to focus on preventing excessive weight gain rather than weight reduction. The proposed intervention, small change approach (SCA), is an innovative weight gain prevention strategy in which individuals monitor their usual nutrition and physical activity patterns and then make modest but sustainable alterations through behavioral intervention techniques (self-regulation, goal setting) enough to reduce overall energy balance by 100 to 200 kcal per day (e.g., reduce caloric intake by 100 kcal per day and/or increase daily step count by ~ 2000 steps (~ 100 kcal) per day). The primary aim of the trial is to determine whether small changes in energy expenditure and/or energy intake prevent weight gain in overweight and obese men and women long-term. The pre-specified primary and secondary assessments are at 2 and 3 years post-randomization respectively. The primary outcome is change in body weight. Secondary outcomes include body composition variables (adipose tissue distribution and lean mass distribution) and cardiorespiratory fitness (VO_2peak).We randomized 320 primarily White (n = 305) overweight and obese men and women to one of 2 conditions: 1) usual care (UC), 2) small change approach (SCA). Participant involvement in the study is 3 years; 2 year intervention with a 1 year follow-up. Our study findings will indicate whether there is value in clinicians adopting a SCA to lifestyle counseling for their patients who are overweight and obese.     

Recruitment strategies,design, and participant characteristics in a trial of weight-loss and metformin in breast cancer survivors

Weight loss and metformin are hypothesized to improve breast cancer outcomes; however the joint impacts of these treatments have not been investigated.Reach for Health is a randomized trial using a 2 × 2 factorial design to investigate the effects of weight loss and metformin on biomarkers associated with breast cancer prognosis among overweight/obese postmenopausal breast cancer survivors. This paper describes the trial recruitment strategies, design, and baseline sample characteristics.Participants were randomized in equal numbers to (1) placebo, (2) metformin, (3) weight loss intervention and placebo, or (4) weight-loss intervention and metformin. The lifestyle intervention was a personalized, telephone-based program targeting a 7% weight-loss in the intervention arm. The metformin dose was 1500 mg/day. The duration of the intervention was 6 months. Main outcomes were biomarkers representing 3 metabolic systems putatively related to breast cancer mortality: glucoregulation, inflammation, and sex hormones.Between August 2011 and May 2015, we randomized 333 breast cancer survivors. Mass mailings from the California Cancer Registry were the most successful recruitment strategy with over 25,000 letters sent at a cost of $191 per randomized participant. At baseline, higher levels of obesity were significantly associated with worse sleep disturbance and impairment scores, lower levels of physical activity and higher levels of sedentary behavior, hypertension, hypercholesterolemia, and lower quality of life (p < 0.05 for all). These results illustrate the health burden of obesity.Results of this trial will provide mechanistic data on biological pathways and circulating biomarkers associated with lifestyle and pharmacologic interventions to improve breast cancer prognosis.     

Mobile health and supervised rehabilitation versus mobile health alone in breast cancer survivors: Randomized controlled trial

BackgroundSurvival rates in cancer are increasing exponentially, with a corresponding increase/influence in disability-adjusted life-years. Efforts should be made to explore the optimal balance between unsupervised/distance-based and supervised/onsite approaches to cancer care.ObjectiveThis study aimed to compare the clinical efficacy of the BENECA mobile Health (mHealth) lifestyle application combined with a supervised rehabilitation program (BENECA and supervised rehabilitation) versus the BENECA mHealth lifestyle application alone on quality of life (QoL) and functional outcomes of breast cancer survivors.MethodsThis randomized controlled trial included 80 survivors of breast cancer diagnosed at stage I–IIIA, who completed adjuvant therapy and were overweight or obese at diagnosis. Participants were randomly allocated (ratio 1:1, 3 waves) to BENECA mHealth and rehabilitation for 2 months (n = 40) or BENECA mHealth and usual care (BENECA mHealth alone; n = 40). Participants completed a questionnaire at baseline (T1), 8-weeks post-intervention (T2) and 6-month follow-up (T3). The primary outcome was QoL assessed with the EORT QLQ-C30. Secondary outcomes included upper-limb functionality and body composition. Statistical (between-group analyses of covariance) and clinical effects were analyzed by intention to treat.ResultsBoth groups showed improved outcomes, but global QoL was significantly better with BENECA mHealth and rehabilitation than BENECA mHealth alone (mean difference, 12.76; 95% confidence interval 4.85; 20.67; P = 0.004), with a moderate-to-large effect size (d = 72). The proportion of participants reporting reliable clinical improvement on global QoL at T2 was higher with BENECA mHealth and rehabilitation than BENECA mHealth alone (57.5% vs 26.3%, P = 0.008). Improvement in subjective and objective upper-limb functionality was also higher with BENECA mHealth and rehabilitation.ConclusionsThe BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.     

FTO and MC4R gene variants determine BMI changes in children after intensive lifestyle intervention

ObjectivesThis study aimed to determine whether there is a relationship between common FTO (rs17817449) and MC4R (rs17782313) gene variants and body mass reduction or weight loss after a one-month lifestyle intervention in overweight/obese children.Design and methodsWe genotyped 357 unrelated non-diabetic Czech children (age 13.7 ± 4.9 years, average BMI at baseline 30.8 ± 4.6 kg/m²). Biochemical and anthropometrical measurements were performed before and after 4 weeks of lifestyle interventions (comprising a reduction in energy intake to the age-matched optimum and a supervised exercise program consisting of 5 exercise units per day, 50 min each).ResultsThe mean weight loss achieved was 6.2 ± 2.1 kg (P < 0.001). Significant associations were found between a BMI decrease and the FTO and MC4R variants. Carriers of the FTO GG genotype and/or MC4R CC genotype lost significantly more body weight compared to noncarriers (P < 0.0009 for BMI and P < 0.002 for body weight). These differences remained significant following adjustment for sex, age and baseline values (P = 0.004 for BMI and P = 0.01 for body weight).ConclusionsFTO and MC4R gene variants modify the impact of an intensive lifestyle intervention on BMI decrease in overweight/obese children. Carriers of the FTO GG genotype and MC4R CC genotype benefit significantly more from the lifestyle intervention.     

Foot dimensions and morphology in healthy weight,overweight and obese males

BackgroundOverweight and obesity are increasing in prevalence. However, despite reports of poor foot health, the influence of obesity and overweight on adult foot morphology has received limited attention. The objective of this work is to accurately and appropriately quantify the foot morphology of adults who are overweight and obese.MethodsThe foot morphology of 23 healthy weight (BMI = 22.9 kg.m^− 2), overweight (27.5 kg.m^− 2) and obese (32.9 kg.m^− 2) age (60 years) matched males was quantified using a 3D scanner (all size UK 9). Data analysis computed normalised (to foot length) standard anatomical measures, and widths, heights and circumferences of 31 evenly spaced cross-sections of right feet.FindingsAnatomical measures of foot, ball and heel width, ball and heel circumference and ball height were all greater in the obese group than the healthy weight (P < 0.05). Cross-sectional measures were significantly wider than the healthy group for the majority of measures from 14 to 67% (P = 0.025–1.000) of heel-to-toe length. Also, the obese group had significantly higher midfoot regions (P = 0.024–0.025). This increased foot height was not evident from anatomical measures, which were not sensitive enough to detect dimensional differences in this foot region.InterpretationFeet of obese adults differ from healthy and overweight individuals, notably they are wider. Data needs to avoid reliance upon discrete anatomical landmarks to describe foot morphology. In the obese, changes in foot shape do not coincide with traditional anatomical landmarks and more comprehensive foot shape data are required to inform footwear design.     

Effect of integrated caregiver support on caregiver burden for people taking care of people with cancer at the end of life: A cohort and quasi-experimental clinical trial

BackgroundPrevious studies have shown small-to-medium effects of support on reducing the caregiver burden for advanced cancer patients. A dearth of studies utilized longitudinal design to examine and evaluate the effect of support for the caregiving burden till the patient's death.ObjectivesTo test the ability of an integrative intervention program for caregivers of advanced cancer patients to lower caregiving burden as death approaches.DesignA two-group comparative design with repeated measures.SettingTwo cancer wards of a single university hospital.ParticipantsAdvanced cancer patients (N = 81) and their caregivers were allocated into two groups: an experimental group (N = 40) receiving coping strategies, assistance, recourses, and education intervention and a control group (N = 41) receiving standard care.MethodsCaregivers received training in the caregiver support intervention at least 3 times every 2 weeks to help them reduce their caregiving burden. Subjective (Caregiver Reaction Assessment) and objective (Heart Rate Variability) measures of caregiver burden were evaluated for caregivers of patients approaching death. Only data within 3 months before the patients’ death were analyzed.ResultsCaregiver self-efficacy significantly increased and the subjective caregiving burden significantly decreased in the experimental group as patients’ death approached. Heart Rate Variability also indicated a calming effect of the intervention, helping caregivers face patients’ death.ConclusionsThe caregiver support intervention can increase caregiver self-efficacy and reduce the subjective caregiving burden. Heart Rate Variability parameters have the potential to be useful for monitoring caregiver burden in facing patients’ death.     

Small Changes and Lasting Effects (SCALE) Trial: The Formation of a Weight Loss Behavioral Intervention Using EVOLVE

BackgroundObesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss.MethodsUsing a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant’s values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months.ResultsOver 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis.ConclusionThe present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone.     

Family,community and clinic collaboration to treat overweight and obese children: Stanford GOALS—A randomized controlled trial of a three-year,multi-component,multi-level,multi-setting intervention

ObjectiveTo test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children.DesignTwo-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization.ParticipantsSeven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California.InterventionsFamilies are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families.Main outcome measureBody mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures.ConclusionsThe Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families.     

The effectiveness of lifestyle intervention in early pregnancy to prevent gestational diabetes mellitus in Chinese overweight and obese women: A quasi-experimental study

PurposeGestational diabetes mellitus (GDM) is one of the most common complications of pregnancy and is associated with substantially elevated risk of adverse health outcomes for both mothers and offspring. This quasi-experimental trial was conducted to assess whether a lifestyle intervention in early pregnancy can reduce the incidence of GDM and excessive gestational weight (GWG) gain among Chinese overweight women.MethodsConvenience samples of 74 women in gestational weeks 8–12 with a BMI ≥ 24 kg/m² were enrolled. They were divided into intervention (N = 37) or control group (N = 37) according to the time sequence of seeing the doctor. The intervention group was provided with exercise, dietary, weight gain counseling and detailed plans at weeks 8–12 and every month in the second trimester. In addition, each counseling session included a personalized feedback based on their 5-day-records. Follow-up phone calls or emails were conducted every week between antenatal visits. The control group was just provided with exercise, dietary and weight gain counseling at weeks 8–12, besides the usual health education provided at the O&G outpatient department.ResultsThe lifestyle intervention resulted in a lower incidence of gestational diabetes in the intervention group (9/32, 28.1%) compared with the control group (19/34, 55.9%), p = 0.023. Women in the intervention group gained much less weight (6.86 ± 2.31 versus 10.08 ± 3.84 kg, p = 0.000) at the end of second trimester.ConclusionLifestyle intervention in early pregnancy can reduce the incidence of GDM and prevent excessive maternal weight gain in overweight and obese pregnant women.     

The GO-ACTIWE randomized controlled trial - An interdisciplinary study designed to investigate the health effects of active commuting and leisure time physical activity

Regular physical activity is efficacious for improving metabolic health in overweight and obese individuals, yet, many adults lead sedentary lives. Most exercise interventions have targeted leisure time, but physical activity also takes place in other domains of everyday life. Active commuting represents a promising alternative to increase physical activity, but it has yet to be established whether active commuting conveys health benefits on par with leisure time physical activity (LTPA). A 6-month randomized controlled trial was designed to investigate the effects of increased physical activity in transport (bicycling) or leisure time domains (moderate or vigorous intensity endurance exercise). We included 188 overweight and class 1 obese sedentary women and men (20–45 years) of which 130 were randomized to either sedentary controls (n = 18), active commuting (n = 35) or moderate (n = 39) or vigorous (n = 38) intensity LTPA. At baseline and after 3 and 6 months, participants underwent a rigorous 3-day biomedical test regimen followed by free-living measurements. In a sub-sample, physical activity level and energy expenditure were monitored by means of personal assistive technology and the doubly labeled water technique. Additionally, the delivery, reception and routinization of the exercise regimens were investigated by ethnological fieldwork. One year after termination of the intervention, participants will be invited for a follow-up visit to investigate sustained health effects and continuous physical activity adherence. By combining biomedical, technological and humanistic approaches, we aim to understand the health benefits of physical activity in different domains of everyday life, as well as how to improve adherence to physical activity.     

The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study

BackgroundNon-alcoholic fatty liver disease is the most frequent liver abnormality observed in overweight or obese children and is strongly associated with metabolic syndrome and insulin resistance.Objectives(i) To evaluate the effect of a 22-week multidisciplinary intervention program on hepatic fat fraction in overweight or obese children and (ii) to examine the effect of the intervention on cardiometabolic risk factors, self-esteem and well-being.MethodsA total of 160 children, 9–11 years, will be recruited by pediatricians and randomly assigned to control (N = 80) or intervention (N = 80) groups. The control group will receive a family-based lifestyle and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week). The duration of training sessions will be 90 min of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises. The primary outcome is the change in hepatic fat fraction (magnetic resonance imaging, MRI). Secondary outcomes include cardiometabolic risk factors such as total adiposity (dual X-ray absorptiometry), visceral adiposity (MRI), functional peak aerobic capacity (cardiopulmonary exercise testing), blood pressure, muscular fitness, speed–agility, and fasting blood insulin, glucose, C-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, lipid profile and psychological measurements (questionnaires). All the measurements will be evaluated at baseline prior to randomization and after the intervention.DiscussionThis study will provide insight in the efficacy of a multidisciplinary intervention program including healthy lifestyle education, psycho-education and supervised exercise to reduce hepatic fat and cardiometabolic risk in overweight children.     

Prevalence of overweight and obesity among nurses in Scotland: A cross-sectional study using the Scottish Health Survey

BackgroundIncreasing prevalence of overweight and obesity represents a global pandemic. As the largest occupational group in international healthcare systems nurses are at the forefront of health promotion to address this pandemic. However, nurses own health behaviours are known to influence the extent to which they engage in health promotion and the public's confidence in advice offered. Estimating the prevalence of overweight and obesity among nurses is therefore important. However, to date, prevalence estimates have been based on non-representative samples and internationally no studies have compared prevalence of overweight and obesity among nurses to other healthcare professionals using representative data.ObjectivesTo estimate overweight and obesity prevalence among nurses in Scotland, and compare to other healthcare professionals and those working in non-heath related occupations.DesignCross-sectional study using a nationally representative sample of five aggregated annual rounds (2008–2012) of the Scottish Health Survey.SettingScotland.Participants13,483 adults aged 17–65 indicating they had worked in the past 4 weeks, classified in four occupational groups: nurses (n = 411), other healthcare professionals (n = 320), unqualified care staff (n = 685), and individuals employed in non-health related occupations (n = 12,067).Main outcome measuresPrevalence of overweight and obesity defined as Body Mass Index ≥ 25.0.MethodsEstimates of overweight and obesity prevalence in each occupational group were calculated with 95% confidence intervals (CI). A logistic regression model was then built to compare the odds of being overweight or obese with not being overweight or obese for nurses in comparison to the other occupational categories. Data were analysed using SAS 9.1.3.Results69.1% (95% CI 64.6, 73.6) of Scottish nurses were overweight or obese. Prevalence of overweight and obesity was higher in nurses than other healthcare professionals (51.3%, CI 45.8, 56.7), unqualified care staff (68.5%, CI 65.0, 72.0) and those in non-health related occupations (68.9%, CI 68.1, 69.7). A logistic regression model adjusted for socio-demographic composition indicated that, compared to nurses, the odds of being overweight or obese was statistically significantly lower for other healthcare professionals (Odds Ratio [OR] 0.45, CI 0.33, 0.61) and those in non-health related occupations (OR 0.78, CI 0.62, 0.97).ConclusionsPrevalence of overweight and obesity among Scottish nurses is worryingly high, and significantly higher than those in other healthcare professionals and non-health related occupations. High prevalence of overweight and obesity potentially harms nurses’ own health and hampers the effectiveness of nurses’ health promotion role. Interventions are therefore urgently required to address overweight and obesity among the Scottish nursing workforce.     

The effectiveness of manual-guided,problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up

BackgroundFamily intervention for psychotic disorders is an integral part of psychiatric treatment with positive effects on patients’ mental state and relapse rate. However, the effect of such family-based intervention on caregivers’ psychological distress and well-being, especially in non-Western countries, has received comparatively much less attention.ObjectivesTo test the effects of guided problem-solving-based manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis over a 6-month period of follow-up, when compared with those in usual family support service.DesignA single-centre randomised controlled trial, which was registered at ClinicalTrials.gov (NCT02391649), with a repeated-measures, two-arm (parallel-group) design.SettingsOne main psychiatric outpatient clinic in the New Territories of Hong Kong.ParticipantsA random sample of 116 family caregiverss of adult outpatients with recent-onset psychosis.MethodsFollowing pre-test measurement, caregivers were assigned randomly to one of two study groups: a 5-month self-help, problem-solving-based manual-guided self-learning (or bibliotherapy) programme (in addition to usual care), or usual family support service only. Varieties of patient and caregiver health outcomes were assessed and compared at baseline and at 1-week and 6-month post-intervention.ResultsOne hundred and eleven (96%) caregivers completed the 6-month follow-up (two post-tests); 55 of them (95%) completed ≥4 modules and attended ≥2 review sessions (i.e., 75% of the intervention). The family participants’ mean age was about 38 years and over 64% of them were female and patient's parent or spouse. Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110) = 6.21, p = 0.006] and caregiving experience [F(1,110) = 6.88, p = 0.0004], and patients’ psychotic symptoms [F(1,110) = 6.25, p = 0.0003], functioning [F(1,110) = 7.01, p = 0.0005] and number of hospitalisations [F(1,110) = 5.71, p = 0.005] over 6-month follow-up.ConclusionsProblem-solving-based, manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis can be an effective self-help programme and provide medium-term benefits to patients’ and caregivers’ mental health and duration of patients’ re-hospitalisations.     

Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART

Background/aimsPain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality.Methods/designBreast cancer patients (N = 327) having pain (ratings ≥ 5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing.ConclusionsNovel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses.     

Post-operative red cell salvage in total knee replacement

Post-operative cell salvage (PCS) reduces homologous blood use after knee replacement but liberal indication for transfusion in previous studies resulted in high homologous transfusion requirements. We evaluated PCS in patients undergoing knee replacement using a restrictive transfusion trigger (Hb <8.5 g/dl). Forty patients underwent knee replacement with either PCS (n=20) or with standard wound drains (n=20). Blood losses and transfusion requirements were recorded prospectively. Mean (SD) post-operative blood loss with PCS was 656 (317) ml, of which 433 (197) ml were re-infused. Control blood loss was comparable at 591 (328) ml. Blood transfusion was given to only one PCS patient; 2 U, and five controls who received a total of 12 U of homologous blood.Homologous transfusion was not necessary for most patients undergoing knee replacement when the indication for transfusion was restricted. PCS further decreased homologous blood requirements.