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Determinants of long-term outcome in ICU survivors: results from the FROG-ICU study.
Gayat, E, Cariou, A, Deye, N, Vieillard-Baron, A, Jaber, S, Damoisel, C, Lu, Q, Monnet, X, Rennuit, I, Azoulay, E, et al
Critical care (London, England). 2018;(1):8
Abstract
BACKGROUND Intensive care unit (ICU) survivors have reduced long-term survival compared to the general population. Identifying parameters at ICU discharge that are associated with poor long-term outcomes may prove useful in targeting an at-risk population. The main objective of the study was to identify clinical and biological determinants of death in the year following ICU discharge. METHODS FROG-ICU was a prospective, observational, multicenter cohort study of ICU survivors followed 1 year after discharge, including 21 medical, surgical or mixed ICUs in France and Belgium. All consecutive patients admitted to intensive care with a requirement for invasive mechanical ventilation and/or vasoactive drug support for more than 24 h following ICU admission and discharged from ICU were included. The main outcome measure was all-cause mortality at 1 year after ICU discharge. Clinical and biological parameters on ICU discharge were measured, including the circulating cardiovascular biomarkers N-terminal pro-B type natriuretic peptide, high-sensitive troponin I, bioactive-adrenomedullin and soluble-ST2. Socioeconomic status was assessed using a validated deprivation index (FDep). RESULTS Of 1570 patients discharged alive from the ICU, 333 (21%) died over the following year. Multivariable analysis identified age, comorbidity, red blood cell transfusion, ICU length of stay and abnormalities in common clinical factors at the time of ICU discharge (low systolic blood pressure, temperature, total protein, platelet and white cell count) as independent factors associated with 1-year mortality. Elevated biomarkers of cardiac and vascular failure independently associated with 1-year death when they are added to multivariable model, with an almost 3-fold increase in the risk of death when combined (adjusted odds ratio 2.84 (95% confidence interval 1.73-4.65), p < 0.001). CONCLUSIONS The FROG-ICU study identified, at the time of ICU discharge, potentially actionable clinical and biological factors associated with poor long-term outcome after ICU discharge. Those factors may guide discharge planning and directed interventions. TRIAL REGISTRATION ClinicalTrials.gov NCT01367093 . Registered on 6 June 2011.
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Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.
Koutoukidis, DA, Beeken, RJ, Manchanda, R, Burnell, M, Knobf, MT, Lanceley, A
Trials. 2016;(1):130
Abstract
BACKGROUND Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity. METHODS/DESIGN This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention. DISCUSSION The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.
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The Kanker Nazorg Wijzer (Cancer Aftercare Guide) protocol: the systematic development of a web-based computer tailored intervention providing psychosocial and lifestyle support for cancer survivors.
Willems, RA, Bolman, CA, Mesters, I, Kanera, IM, Beaulen, AA, Lechner, L
BMC cancer. 2015;:580
Abstract
BACKGROUND After primary treatment, many cancer survivors experience psychosocial, physical, and lifestyle problems. To address these issues, we developed a web-based computer tailored intervention, the Kanker Nazorg Wijzer (Cancer Aftercare Guide), aimed at providing psychosocial and lifestyle support for cancer survivors. The purpose of this article is to describe the systematic development and the study design for evaluation of this theory and empirical based intervention. METHODS/DESIGN For the development of the intervention, the steps of the Intervention Mapping protocol were followed. A needs assessment was performed consisting of a literature study, focus group interviews, and a survey study to get more insight into cancer survivors' health issues. This resulted in seven problem areas that were addressed in the intervention: cancer-related fatigue, return to work, anxiety and depression, social relationships and intimacy, physical activity, diet, and smoking. To address these problem areas, the principles of problem-solving therapy and cognitive behavioral therapy are used. At the start of the intervention, participants have to fill in a screening questionnaire. Based on their answers, participants receive tailored advice about which problem areas deserve their attention. Participants were recruited from November 2013 through June 2014 by hospital staff from 21 hospitals in the Netherlands. Patients were selected either during follow-up visits to the hospital or from reviews of the patients' files. The effectiveness of the intervention is being tested in a randomized controlled trial consisting of an intervention group (n = 231) and waiting list control group (n = 231) with a baseline measurement and follow-up measurements at 3, 6, and 12 months. DISCUSSION Using the Intervention Mapping protocol resulted in a theory and evidence-based intervention providing tailored advice to cancer survivors on how to cope with psychosocial and lifestyle issues after primary treatment. TRIAL REGISTRATION Dutch Trial Register NTR3375.
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Study design and protocol for moving forward: a weight loss intervention trial for African-American breast cancer survivors.
Stolley, MR, Sharp, LK, Fantuzzi, G, Arroyo, C, Sheean, P, Schiffer, L, Campbell, R, Gerber, B
BMC cancer. 2015;:1018
Abstract
BACKGROUND Breast cancer survival rates are significantly lower among African-American women compared to white women. In addition, African-American women with breast cancer are more likely than white women to die from co-morbid conditions. Obesity is common among African-American women, and it contributes to breast cancer progression and the development and exacerbation of many weight-related conditions. Intervening upon obesity may decrease breast cancer and all-cause mortality among African-American breast cancer survivors. METHODS/DESIGN Moving Forward is a weight loss intervention being evaluated in a randomized trial with a projected sample of 240 African American breast cancer survivors. Outcomes include body mass index, body composition, waist:hip ratio, and behavioral, psychosocial and physiological measures. Survivors are randomized to either a 6-month guided weight loss intervention that involves twice weekly classes and text messaging or a self-guided weight loss intervention based on the same materials offered in the guided program. The guided intervention is being conducted in partnership with the Chicago Park District at park facilities in predominantly African-American neighborhoods in Chicago. Recruitment strategies include direct contact to women identified in hospital cancer registries, as well as community-based efforts. Data collection occurs at baseline, post-intervention (6 months) and at a 12-month follow-up. DISCUSSION This study evaluates a community-based, guided lifestyle intervention designed to improve the health of African-American breast cancer survivors. Few studies have addressed behavioral interventions in this high-risk population. If successful, the intervention may help reduce the risk for breast cancer recurrence, secondary cancers, and co-morbid conditions, as well as improve quality of life. TRIAL REGISTRATION U.S. Clinicaltrials.gov number: NCT02482506, April 2015.
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Predictors of post-traumatic psychological growth in the late years after lung transplantation.
Fox, KR, Posluszny, DM, DiMartini, AF, DeVito Dabbs, AJ, Rosenberger, EM, Zomak, RA, Bermudez, C, Dew, MA
Clinical transplantation. 2014;(4):384-93
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Abstract
BACKGROUND Although lung transplantation improves quality of life, most psychosocial research focuses on adverse psychological and social functioning outcomes. Positive effects, particularly in the late-term years as physical morbidities increase, have received little attention. We provide the first data on a psychological benefit - post-traumatic growth (PTG) - and we focused on long-term (>5 yr) survivors. METHODS Among 178 patients from a prospective study of mental health during the first two yr post-transplant, we recontacted survivors 6-11 yr post-transplant. We assessed PTG (i.e., positive psychological change resulting from the transplant) and examined its relationship to other patient characteristics with multivariable regression analyses. RESULTS Sixty-four patients (86% of survivors) were assessed (M = 8.1 yr post-transplant, SD = 1.2). Mean PTG exceeded the scale's midpoint (M = 38.6, SD = 10.0; scale midpoint = 25). Recipients experiencing greater PTG were female (p = 0.022), less educated (p = 0.014), and had a history of post-transplant panic disorder (p = 0.005), greater friend support (p = 0.048), and better perceived health (p = 0.032). Neither other pre- or post-transplant mood and anxiety disorders nor transplant-related morbidities (acute rejection, bronchiolitis obliterans syndrome) predicted PTG. CONCLUSIONS PTG exceeded levels observed in other chronic disease populations, suggesting that lung transplantation may uniquely foster positive psychological change in long-term survivors. PTG occurs despite physical and psychiatric morbidities. Whether PTG promotes other positive post-transplant psychosocial outcomes deserves attention.
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Cancer-specific concerns and physical activity among recently diagnosed breast and prostate cancer survivors.
Ottenbacher, A, Sloane, R, Snyder, DC, Kraus, W, Sprod, L, Demark-Wahnefried, W
Integrative cancer therapies. 2013;(3):206-12
Abstract
BACKGROUND Cancer treatment -related side effects may have a negative impact on quality of life among cancer survivors and may limit participation in physical activity (PA). HYPOTHESIS Cancer-specific concerns will be reduced throughout a 10-month diet and exercise intervention among recently diagnosed cancer survivors. Additionally, participants reporting greater levels of PA will also report fewer cancer-specific concerns. STUDY DESIGN This study is an exploratory analysis of 452 recently diagnosed, early-stage breast and prostate cancer survivors who participated in the FRESH START diet and exercise trial. Data were collected at baseline and 1-year follow-up. RESULTS At baseline, chief concerns among prostate cancer survivors included ability to have an erection (mean score [standard deviation] = 1.0 [1.3]) and urinary frequency (2.5 [1.4]), whereas among breast cancer survivors, eminent concerns were not feeling sexually attractive (2.0 [1.3]) and worry about cancer in other members of their family (2.1 [1.3]). At 1 year, there was a significant improvement in cancer-specific concerns on breast cancer-specific concerns (P < .01) but not on prostate cancer-specific concerns. At baseline, women who were self-conscious about their dress had higher levels of PA, whereas men reporting issues with incontinence reported lesser increases in PA in response to the intervention. CONCLUSION Cancer-specific concerns diminish over time, especially among breast cancer survivors. Among prostate cancer survivors, incontinence is a significant barrier that hinders benefit from PA interventions. Thus, there is a need either for medical interventions to ameliorate incontinence or for behavioral interventions to address this issue among survivors.
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Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors.
Demark-Wahnefried, W, Morey, MC, Sloane, R, Snyder, DC, Miller, PE, Hartman, TJ, Cohen, HJ
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2012;(19):2354-61
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PURPOSE Diet and exercise interventions have been tested in cancer survivors as a means to reduce late effects and comorbidity, but few have assessed adherence and health outcomes long term. METHODS Between July 2005 and May 2007, the Reach Out to Enhance Wellness (RENEW) trial accrued 641 locoregionally staged, long-term (≥ 5 years from diagnosis) colorectal, breast, and prostate cancer survivors in the United States (21 states), Canada, and the United Kingdom. All participants were sedentary (< 150 minutes of physical activity [PA] a week), overweight or obese (body mass index, 25 to 40 kg/m(2)), and over age 65 years. The trial tested a diet-exercise intervention delivered via mailed print materials and telephone counseling. RENEW used a wait-list control, cross-over design (ie, participants received the year-long intervention immediately or after a 1-year delay), which allowed the opportunity to assess program efficacy (previously reported primary outcome), durability, and reproducibility (reported herein). Measures included diet quality (DQ), PA, BMI, and physical function (PF). RESULTS No significant relapse was observed in the immediate-intervention arm for DQ, PA, and BMI; however, rates of functional decline increased when the intervention ceased. From year 1 to year 2, significant improvements were observed in the delayed-intervention arm; mean change scores in behaviors and BMI and PF slopes were as follows: DQ score, 5.2 (95% CI, 3.4 to 7.0); PA, 45.8 min/wk (95% CI, 26.9 to 64.6 min/wk); BMI, -0.56 (95% CI, -0.75 to -0.36); and Short Form-36 PF, -1.02 versus -5.52 (P < .001 for all measures). Overall, both arms experienced significant improvements in DQ, PA, and BMI from baseline to 2-year follow-up (P < .001). CONCLUSION Older cancer survivors respond favorably to lifestyle interventions and make durable changes in DQ and PA that contribute to sustained weight loss. These changes positively reorient functional decline trajectories during intervention delivery.
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Randomized controlled trial of exercise and blood immune function in postmenopausal breast cancer survivors.
Fairey, AS, Courneya, KS, Field, CJ, Bell, GJ, Jones, LW, Mackey, JR
Journal of applied physiology (Bethesda, Md. : 1985). 2005;(4):1534-40
Abstract
The objective was to determine the effects of exercise training on changes in blood immune function in postmenopausal breast cancer survivors. Fifty-three postmenopausal breast cancer survivors were randomly assigned to an exercise (n=25) or control group (n=28). The exercise group trained on cycle ergometers three times per week for 15 wk. The control group did not train. The primary end point was change in natural killer cell cytotoxic activity in isolated peripheral blood mononuclear cells. Secondary end points were changes in standard hematological variables, whole blood neutrophil function, the phenotypes of isolated mononuclear cells, estimations of unstimulated and phytohemaglutinin-stimulated mononuclear cell function (rate of [3H]thymidine uptake), and the production of proinflammatory [interleukin (IL)-1alpha, tumor necrosis factor-alpha, IL-6] and anti-inflammatory cytokines (IL-4, IL-10, transforming growth factor-beta1). Statistical tests were two-sided (alpha <0.05). Fifty-two participants completed the trial. Intention-to-treat analyses, which included the baseline value as a covariate, showed significant differences between groups for change in percent specific lysis of a target natural killer cell at all five effector-to-target ratios (adjusted mean between-group change over all 5 effector-to-target ratios = +6.34%; P <0.05 for all comparisons), the lytic activity per cell (adjusted mean between-group change = -2.72 lytic units; P=0.035), and unstimulated [3H]thymidine uptake by peripheral blood lymphocytes (adjusted mean between-group change = +218 per dpm x 10(6) cells; P = 0.007). There were no significant differences between groups for change in any other end point. Exercise training increased natural killer cell cytotoxic activity and unstimulated [3H]thymidine uptake by peripheral blood lymphocytes in postmenopausal breast cancer survivors.