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Comprehensive versus standard care in post-severe acute kidney injury survivors, a randomized controlled trial.
Thanapongsatorn, P, Chaikomon, K, Lumlertgul, N, Yimsangyad, K, Leewongworasingh, A, Kulvichit, W, Sirivongrangson, P, Peerapornratana, S, Chaijamorn, W, Avihingsanon, Y, et al
Critical care (London, England). 2021;(1):322
Abstract
BACKGROUND Currently, there is a lack of evidence to guide optimal care for acute kidney injury (AKI) survivors. Therefore, post-discharge care by a multidisciplinary care team (MDCT) may improve these outcomes. This study aimed to demonstrate the outcomes of implementing comprehensive care by a MDCT in severe AKI survivors. METHODS This study was a randomized controlled trial conducted between August 2018 to January 2021. Patients who survived severe AKI stage 2-3 were enrolled and randomized to be followed up with either comprehensive or standard care for 12 months. The comprehensive post-AKI care involved an MDCT (nephrologists, nurses, nutritionists, and pharmacists). The primary outcome was the feasibility outcomes; comprising of the rates of loss to follow up, 3-d dietary record, drug reconciliation, and drug alert rates at 12 months. Secondary outcomes included major adverse kidney events, estimated glomerular filtration rate (eGFR), and the amount of albuminuria at 12 months. RESULTS Ninety-eight AKI stage 3 survivors were enrolled and randomized into comprehensive care and standard care groups (49 patients in each group). Compared to the standard care group, the comprehensive care group had significantly better feasibility outcomes; 3-d dietary record, drug reconciliation, and drug alerts (p < 0.001). The mean eGFR at 12 months were comparable between the two groups (66.74 vs. 61.12 mL/min/1.73 m2, p = 0.54). The urine albumin: creatinine ratio (UACR) was significantly lower in the comprehensive care group (36.83 vs. 177.70 mg/g, p = 0.036), while the blood pressure control was also better in the comprehensive care group (87.9% vs. 57.5%, p = 0.006). There were no differences in the other renal outcomes between the two groups. CONCLUSIONS Comprehensive care by an MDCT is feasible and could be implemented for severe AKI survivors. MDCT involvement also yields better reduction of the UACR and better blood pressure control. Trial registration Clinicaltrial.gov: NCT04012008 (First registered July 9, 2019).
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A Pilot Randomized Controlled Trial Testing the Feasibility and Acceptability of a SystemCHANGE Intervention to Improve Medication Adherence in Older Adult Stroke Survivors.
Wessol, JL, Russell, CL, Olds, KE
The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses. 2019;(5):259-265
Abstract
BACKGROUND Adhering to an antithrombotic medication regimen is essential to reducing recurrent stroke in adult stroke survivors. The purpose of this study was to evaluate the feasibility and acceptability of the SystemCHANGE (SC) and attention control (AC) intervention in older adult, nonadherent ischemic stroke patients. METHODS A pilot randomized controlled trial was conducted to determine the feasibility and acceptability of an SC versus AC intervention in older adult, nonadherent stroke survivors in the management of antithrombotic medication. Participants were masked to group assignment. Stroke survivors 50 years or older, taking at least 1 once-a-day antithrombotic medication, were recruited from a Midwest Comprehensive Stroke Center-affiliated neurology office. They were screened electronically using the Medication Event Monitoring System for 2 months to determine baseline medication adherence. Nonadherent stroke survivors (medication adherence < 0.97) were randomized to SC or AC intervention and monitored for 3 months. SC focused on redesigning the interpersonal environmental system and daily routines. The AC group was provided education materials on stroke that consisted of stroke risk factor reduction, stroke facts, rehabilitation, and nutrition with the primary investigator. Participation and intervention experience interviews were evaluated for themes. RESULTS Thirty participants were recruited: median age was 64 years, 46.7% of them were male, and they took an average of 7.77 (SD, 3.191; range, 3-15) prescribed medications. The number of over-the-counter medications taken (excluding aspirin) on a regular basis averaged 1.9 (SD, 0.8; range, 1-4). Two participants were nonadherent and were randomized to the 2 arms. Both participants had positive feedback and were not inconvenienced by their participation in the study. Neither participant voiced concerns about the intervention, survey demands, time requirement, or completing the surveys on the primary investigator's laptop. CONCLUSION The SC and AC intervention protocols were feasible and acceptable to the participants in this study. Additional pilot testing is needed to further evaluate the intervention and its effect on medication adherence in this population.
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Determinants of Health-Related Quality of Life After ICU: Importance of Patient Demographics, Previous Comorbidity, and Severity of Illness.
Griffith, DM, Salisbury, LG, Lee, RJ, Lone, N, Merriweather, JL, Walsh, TS, ,
Critical care medicine. 2018;(4):594-601
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OBJECTIVES ICU survivors frequently report reduced health-related quality of life, but the relative importance of preillness versus acute illness factors in survivor populations is not well understood. We aimed to explore health-related quality of life trajectories over 12 months following ICU discharge, patterns of improvement, or deterioration over this period, and the relative importance of demographics (age, gender, social deprivation), preexisting health (Functional Comorbidity Index), and acute illness severity (Acute Physiology and Chronic Health Evaluation II score, ventilation days) as determinants of health-related quality of life and relevant patient-reported symptoms during the year following ICU discharge. DESIGN Nested cohort study within a previously published randomized controlled trial. SETTING Two ICUs in Edinburgh, Scotland. PATIENTS Adult ICU survivors (n = 240) who required more than 48 hours of mechanical ventilation. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS We prospectively collected data for age, gender, social deprivation (Scottish index of multiple deprivation), preexisting comorbidity (Functional Comorbidity Index), Acute Physiology and Chronic Health Evaluation II score, and days of mechanical ventilation. Health-related quality of life (Medical Outcomes Study Short Form version 2 Physical Component Score and Mental Component Score) and patient-reported symptoms (appetite, fatigue, pain, joint stiffness, and breathlessness) were measured at 3, 6, and 12 months. Mean Physical Component Score and Mental Component Score were reduced at all time points with minimal change between 3 and 12 months. In multivariable analysis, increasing pre-ICU comorbidity count was strongly associated with lower health-related quality of life (Physical Component Score β = -1.56 [-2.44 to -0.68]; p = 0.001; Mental Component Score β = -1.45 [-2.37 to -0.53]; p = 0.002) and more severe self-reported symptoms. In contrast, Acute Physiology and Chronic Health Evaluation II score and mechanical ventilation days were not associated with health-related quality of life. Older age (β = 0.33 [0.19-0.47]; p < 0.001) and lower social deprivation (β = 1.38 [0.03-2.74]; p = 0.045) were associated with better Mental Component Score health-related quality of life. CONCLUSIONS Preexisting comorbidity counts, but not severity of ICU illness, are strongly associated with health-related quality of life and physical symptoms in the year following critical illness.
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Breast cancer survivors' experience of making weight, dietary and physical activity changes during participation in a weight loss intervention.
Terranova, CO, Lawler, SP, Spathonis, K, Eakin, EG, Reeves, MM
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2017;(5):1455-1463
Abstract
PURPOSE The aim of this study is to explore breast cancer survivors' experience of a weight loss intervention and identify potential facilitators and barriers of initiating and maintaining weight, dietary or physical activity changes. METHOD Fourteen women randomised to and completing the 12-month weight loss intervention completed semi-structured interviews 7.5 ± 0.5 months after intervention completion. An inductive thematic analysis was conducted whereby interviews were independently coded and themes identified. RESULTS Women were (mean ± SD) 55.6 ± 8.5 years, 30.2 ± 4.6 kg/m2 and 17.1 ± 3.4 months post-diagnosis at study baseline. Four themes emerged: (1) perceived motivation to participate in the intervention, (2) facilitators, (3) challenges and (4) maintenance of weight loss and behaviour changes. All women noted the impact of social/family environments, either to facilitate (e.g., support from family members) or impede (e.g., major family event) changes. The structure and support of the intervention, particularly accountability to their coach, was also seen as facilitating. Formation of habitual physical activity facilitated dietary changes. Dietary change strategies most perceived to facilitate weight loss were reducing energy intake by dietary self-monitoring, increasing vegetable intake and portion control. Challenges included breast cancer-specific issues such as post-diagnosis weight gain, treatment-related side effects and psychological issues around readiness to change and self-regulation. Diminished accountability following intervention completion impacted the maintenance of weight loss and behaviour changes, notably dietary self-monitoring. CONCLUSIONS Results suggest that formal involvement of a support person (e.g. family member/friend) and referring women to ongoing, community-based services to maintain patient-perceived accountability may be particularly useful strategies for future weight loss intervention trials targeting women with breast cancer.
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Higher-intensity exercise helps cancer survivors remain motivated.
Martin, E, Battaglini, C, Hands, B, Naumann, FL
Journal of cancer survivorship : research and practice. 2016;(3):524-33
Abstract
PURPOSE The aim of the present study was to determine if exercise intensity impacts upon the psychosocial responses of breast and prostate cancer survivors to a rehabilitation program. METHODS Eighty-seven prostate and 72 breast cancer survivors participated in an 8-week exercise and supportive group psychotherapy intervention (n = 84) or control (n = 75) group. Intervention participants were randomized to low-to-moderate intensity exercise (LIG; n = 44; 60-65 % VO2peak, 50-65 % one repetition maximum (1RM)) or moderate-to-high intensity exercise (HIG; n = 40; 75-80 % VO2peak, 65-80 % 1RM) while controls continued usual care. Before and after the 8 weeks, all participants completed the Functional Assessment of Cancer Therapy-Breast or -Prostate to assess quality of life (QOL) and Behavioural Regulations of Exercise Version 2 for exercise motivation. Intervention participants also completed a follow-up assessment 4 months post-intervention. RESULTS All three groups improved in QOL from baseline to post-intervention, with no significant differences. From post-intervention to follow-up, the LIG and HIG similarly maintained QOL scores. Between baseline and post-intervention, both intervention arms improved their motivation to exercise compared to the controls (p = 0.004). At the 4-month follow-up, the HIG had maintained their overall exercise motivation (p < 0.001) and both domains of intrinsic motivation (identified regulation, p = 0.047; intrinsic regulation, p = 0.007); however, the LIG had regressed. CONCLUSIONS The structured intervention was successful at improving autonomous exercise motivation, regardless of exercise intensity. However, only those participants who had exercised at a higher intensity sustained their improvement. Intervention participation did not improve QOL more than controls. IMPLICATIONS FOR CANCER SURVIVORS Higher-intensity exercise is more likely to result in more sustainable increases in motivation to exercise among cancer survivors.
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Survivorship care plans and adherence to lifestyle recommendations among breast cancer survivors.
Greenlee, H, Molmenti, CL, Crew, KD, Awad, D, Kalinsky, K, Brafman, L, Fuentes, D, Shi, Z, Tsai, WY, Neugut, AI, et al
Journal of cancer survivorship : research and practice. 2016;(6):956-963
Abstract
PURPOSE The effectiveness of survivorship care plans has not been widely tested. We evaluated whether a one-time brief lifestyle consultation as part of a broader survivorship care plan was effective at changing diet and lifestyle patterns. METHODS A diverse sample of women with stage 0-III breast cancer were randomized to control or intervention groups within 6 weeks of completing adjuvant treatment. Both groups received the National Cancer Institute publication, "Facing Forward: Life after Cancer Treatment." The intervention group also met with a nurse (1 h) and a nutritionist (1 h) to receive personalized lifestyle recommendations based upon national guidelines. Diet, lifestyle, and perceived health were assessed at baseline, 3 and 6 months. Linear regression analyses evaluated the effects of the intervention adjusted for covariates. RESULTS A total of 126 women completed the study (60 control/66 intervention, 61 Hispanic/65 non-Hispanic). At 3 months, the intervention group reported greater knowledge of a healthy diet (P = 0.047), importance of physical activity (P = 0.03), and appropriate use of dietary supplements (P = 0.006) and reported lower frequency of alcohol drinking (P = 0.03) than controls. At 6 months, only greater knowledge of a healthy diet (P = 0.01) persisted. The intervention was more effective among non-Hispanics than Hispanics on improving attitude towards healthy eating (P = 0.03) and frequency of physical activity (P = 0.006). CONCLUSIONS The intervention changed lifestyle behaviors and knowledge in the short-term, but the benefits did not persist. IMPLICATIONS FOR CANCER SURVIVORS Culturally competent long-term behavioral interventions should be tested beyond the survivorship care plan to facilitate long-term behavior change among breast cancer survivors.
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Patient-centered support in the survivorship care transition: Outcomes from the Patient-Owned Survivorship Care Plan Intervention.
Kvale, EA, Huang, CS, Meneses, KM, Demark-Wahnefried, W, Bae, S, Azuero, CB, Rocque, GB, Bevis, KS, Ritchie, CS
Cancer. 2016;(20):3232-3242
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BACKGROUND To the authors' knowledge, few studies to date have evaluated the effects of survivorship care planning on the care transition process from specialty cancer care to self-management and primary care, patient experience, or health outcomes. The Patient-owned Survivorship Transition Care for Activated, Empowered survivors (POSTCARE) is a single coaching encounter based on the Chronic Care Model that uses motivational interviewing techniques to engage survivors of breast cancer. The current study examined the effects of the POSTCARE intervention on patient outcomes and care coordination. METHODS A total of 79 survivors of American Joint Commision on Cancer TNM System stage 0 to IIIB breast cancer were randomized to POSTCARE (40 patients) or usual care (39 patients). Patient outcomes were assessed using the 36-Item Short Form Health Survey (SF-36), Social/Role Activities Limitations, Self-Efficacy for Managing Chronic Disease 6-Item Scale, the Patient Activation Measure-Short Form, and Patient Health Questionnaire depression scale at baseline and at 3-month follow-up. Care coordination was assessed using confirmed primary care physician visits and reported discussion of the survivorship care plan at the 3-month follow-up. Logistic and linear regression analyses were conducted to examine the effect of POSTCARE on selected outcomes. RESULTS Participants in the intervention group versus those receiving usual care demonstrated significantly higher self-reported health (F-statistic (3,71), 3.63; P =.017) and lower social role limitations (F (3,70), 3.82; P =.014) and a trend toward greater self-efficacy (F (3,69), 2.51; P = .07). Three quality-of-life domains reached clinically meaningful improvement at the 3-month follow-up, including physical role (P =.0009), bodily pain (P =.03), and emotional role (P =.04). CONCLUSIONS The POSTCARE intervention appeared to have a positive impact on patient outcomes and demonstrated promise as a strategy with which to improve survivors' experience, care coordination, and health outcomes. Cancer 2016;122:3232-42. © 2016 American Cancer Society.
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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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Social cognitive theory mediators of physical activity in a lifestyle program for cancer survivors and carers: findings from the ENRICH randomized controlled trial.
Stacey, FG, James, EL, Chapman, K, Lubans, DR
The international journal of behavioral nutrition and physical activity. 2016;:49
Abstract
BACKGROUND Despite increasing numbers of cancer survivors and evidence that diet and physical activity improves the health of cancer survivors, most do not meet guidelines. Some social cognitive theory (SCT)-based interventions have increased physical activity behavior, however few have used objective physical activity measures. The Exercise and Nutrition Routine Improving Cancer Health (ENRICH) randomized controlled trial reported a significant intervention effect for the primary outcome of pedometer-assessed step counts at post-test (8-weeks) and follow-up (20-weeks). The aim of this study was to test whether the SCT constructs operationalized in the ENRICH intervention were mediators of physical activity behavior change. METHODS Randomized controlled trial with 174 cancer survivors and carers assessed at baseline, post-test (8-weeks), and follow-up (20-weeks). Participants were randomized to the ENRICH six session face-to-face healthy lifestyle program, or to a wait-list control. Hypothesized SCT mediators of physical activity behavior change (self-efficacy, behavioral goal, outcome expectations, impediments, and social expectations) were assessed using valid and reliable scales. Mediation was assessed using the Preacher and Hayes SPSS INDIRECT macro. RESULTS At eight weeks, there was a significant intervention effect on behavioral goal (A = 9.12, p = 0.031) and outcome expectations (A = 0.25, p = 0.042). At 20 weeks, the intervention had a significant effect on self-efficacy (A = 0.31, p = 0.049) and behavioral goal (A = 13.15, p = 0.011). Only changes in social support were significantly associated with changes in step counts at eight weeks (B = 633.81, p = 0.023). Behavioral goal was the only SCT construct that had a significant mediating effect on step counts, and explained 22 % of the intervention effect at 20 weeks (AB = 397.9, 95 % CI 81.5-1025.5). CONCLUSIONS SCT constructs had limited impact on objectively-assessed step counts in a multiple health behavior change intervention for cancer survivors and their carers. Behavioral goal measured post-intervention was a significant mediator of pedometer-assessed step counts at 3-months after intervention completion, and explained 22 % of the intervention effect. Future research should examine the separate impact of goals and planning, as well as examining mediators of behavior maintenance in physical activity interventions targeting cancer survivors. TRIAL REGISTRATION Australian and New Zealand Clinical Trials registry ANZCTRN1260901086257 .
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The Effect on Bone Outcomes of Adding Exercise to Supplements for Osteopenic Breast Cancer Survivors: A Pilot Randomized Controlled Trial.
Kim, SH, Cho, YU, Kim, SJ, Hong, S, Han, MS, Choi, E
Cancer nursing. 2016;(2):144-52
Abstract
BACKGROUND Cancer treatment-induced bone loss is an important long-term effect in breast cancer survivors, but evidence regarding lifestyle interventions for preventing cancer treatment-induced bone loss is lacking. OBJECTIVE The aim of this study was to investigate the feasibility, safety, and effects of a 6-month combined home-based exercise and calcium and vitamin D supplements (EX + SUPP) intervention compared with calcium and vitamin D supplements alone (SUPP) on bone health of osteopenic breast cancer survivors. METHODS In this pilot randomized controlled trial, we enrolled 43 women with breast cancer who were diagnosed as osteopenic through bone mineral density screening. Women were randomly assigned to the EX + SUPP group (n = 23) or the SUPP group (n = 20). RESULTS The rates of participant retention (90.7%) and of counseling calls delivered to the EX + SUPP group (90.3%) were high. The average exercise adherence rate was 69.5% for weight-bearing exercise and 48.5% for resistance exercise. The EX + SUPP group reported no injuries or adverse events. Despite positive findings of adherence and safety, no significant group differences were observed for bone mineral density, bone turnover marker, or physical performance. CONCLUSIONS A home-based exercise program for bone health among osteopenic breast cancer survivors is feasible and safe. There was no significant additive effect of exercise on bone outcomes under the conditions studied, however, suggesting the need for a larger trial. IMPLICATIONS FOR PRACTICE Effective exercise intervention may require more intensive components such as higher loading forces and longer duration for improving bone health among this population.