Geriatric assessment-driven intervention (GAIN) on chemotherapy toxicity in older adults with cancer: A randomized controlled trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12010-12010 ◽  
Author(s):  
Daneng Li ◽  
Can-Lan Sun ◽  
Heeyoung Kim ◽  
Vincent Chung ◽  
Marianna Koczywas ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Geriatric Assessment ◽  
Average Length ◽  
Controlled Trial ◽  
Stage Iv ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Grade 3 ◽  
The Impact

12010 Background: Geriatric assessment (GA) can predict chemotherapy (chemo) toxicity in older adults (age ≥65) with cancer. However, evidence regarding the effect of GA-driven intervention (GAIN) on the incidence of chemo toxicity has been limited. Therefore, we conducted a randomized controlled trial evaluating the impact of GAIN vs. standard of care (SOC) on chemo toxicity in older adults with cancer. Methods: Patients (pts) age ≥65, diagnosed with a solid malignancy, and starting a new chemo regimen at City of Hope were eligible (NCT02517034). In a 2:1 ratio, 600 pts were randomly assigned to either GAIN (n = 398) or SOC (n = 202) arms. All pts completed a baseline GA prior to chemo. In the GAIN arm, a multidisciplinary team led by a geriatric oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist, reviewed GA results and implemented interventions based on predefined triggers built into the GA’s various domains. In the SOC arm, GA results were sent to treating oncologists to use at their discretion. Pts were followed until either end of chemo or 6 months after start of chemo, whichever occurred first. The primary endpoint was incidence of grade 3-5 chemo-related toxicity (NCI CTCAE v.4.0). Secondary endpoints included advance directive (AD) completion, emergency room (ER) visits, hospitalizations, and average length of stay (ALOS). Chi-square and Fisher’s exact tests were used to compare the categorical outcomes, and Kruskal-Wallis test was used to compare the ALOS between arms. Results: Pt characteristics were balanced between arms. Median age was 71 (range 65-91). Cancer types included: 33% gastrointestinal, 23% breast, 16% lung, 15% genitourinary, and 13% other. Most (71%) had stage IV disease. The incidence of grade 3-5 chemo-related toxicity was 50.5% (95% CI: 45.6-55.4%) in the GAIN arm and 60.4% (95% CI: 53.7-67.1%) in the SOC arm (p = 0.02). Compared to SOC, the GAIN arm had a reduction of 9.9% (95% CI: 1.6-18.2%) in chemo-related toxicity. At the end of study, AD completion increased 24.1% in the GAIN arm vs. 10.4% in the SOC arm (p < 0.001). No significant differences in ER visits (27.4% vs. 30.7%), hospitalizations (22.1% vs. 19.3%), or ALOS (median 4.8 vs. 5.0 days) were observed between the GAIN and SOC arms, respectively. Conclusions: Integration of multidisciplinary GA-driven interventions reduced grade 3-5 chemo-related toxicity and improved AD completion in older adults with cancer. GA-driven interventions should be included as a part of cancer care for all older adults. Clinical trial information: NCT02517034 .

The impact of life review on depression in older adults: a randomized controlled trial

2010 ◽  
Vol 22 (4) ◽  
pp. 572-581 ◽  
Author(s):  
Anne Margriet Pot ◽  
Ernst T. Bohlmeijer ◽  
Simone Onrust ◽  
Anne-Sophie Melenhorst ◽  
Marjolein Veerbeek ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Effect Size ◽  
Comparison Group ◽  
Controlled Trial ◽  
Life Review ◽  
Group Effect ◽  
Randomized Controlled ◽  
The Impact

ABSTRACTBackground: We developed an indicated preventive life-review course, “Looking for Meaning”, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial.Methods: Inclusion criteria were >50 years, a score of 5 or higher on the Center for Epidemiological Studies Depression Scale (CES-D), and no depressive disorder or psychotropic or psychological treatment. Participants were randomized and stratified by gender: the experimental group (N = 83) was offered the course and the comparison group (N = 88) a movie. There were three measurements: pre-treatment, post-treatment and 6 months after post-treatment. Depressive symptoms constituted the primary outcome. Secondary outcomes were anxiety symptoms, satisfaction with life, mastery and reminiscence styles. All analyses were conducted according to the intention-to-treat principle. Missing values were replaced by regression imputation.Results: The course reduced depressive symptoms, a decrease that was retained during follow-up. A significant between-group effect size was found (d = 0.58). There was also a reduction in symptoms of anxiety; however, the comparison group showed the same reduction, resulting in a small between-group effect size. Gender and level of depressive symptoms were found to be prognostic factors for the change in depressive symptoms; age was not. Post hoc analyses showed significant between-group effect sizes for females and those with a score above the cut-off of the CES-D.Conclusion: The course “Looking for Meaning” can be recommended for people aged over 50 years, females and older adults with a clinically relevant level of depressive symptoms (above cut-off) in particular.

scholarly journals Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignancies

Haematologica ◽  
2021 ◽  
Author(s):  
Clark DuMontier ◽  
Hajime Uno ◽  
Tammy Hshieh ◽  
Guohai Zhou ◽  
Richard Chen ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Hematologic Malignancies ◽  
Care Utilization ◽  
Goals Of Care ◽  
Randomized Controlled ◽  
Geriatric Consultation ◽  
The Impact

We conducted a randomized controlled trial in older adults with hematologic malignancies to determine the impact of geriatrician consultation embedded in our oncology clinic alongside standard care. From February 2015 to May 2018, transplant-ineligible patients age ii75 years who presented for initial consultation for lymphoma, leukemia, or multiple myeloma at Dana-Farber Cancer Institute (Boston, MA) were eligible. Pre-frail and frail patients, classified based on phenotypic and deficitaccumulation approaches, were randomized to receive either standard oncologic care with or without consultation with a geriatrician. The primary outcome was 1-year overall survival. Secondary outcomes included unplanned care utilization within 6 months of follow-up and documented end of life (EOL) goals of care discussions. Clinicians were surveyed as to their impressions of geriatric consultation. One hundred sixty patients were randomized to either geriatric consultation plus standard care (n = 60) or standard care alone (n = 100). Median age was 80.4 years (SD = 4.2). Of those randomized to geriatric consultation, 48 (80%) completed at least one visit with a geriatrician. Consultation did not improve survival at one year compared to standard care (difference: 2.9%, 95% CI = -9.5% to 15.2%, p = 0.65), and did not significantly reduce the incidence of ED visits, hospitalizations, or days in hospital. Consultation did improve the odds of having EOL goals of care discussions (odds ratio = 3.12, 95% CI = 1.03 to 9.41) and was valued by surveyed hematologiconcology clinicians, with 62.9%-88.2% rating consultation as useful in the management of several geriatric domains.

Investigating bacterial decolonization for the prevention of radiation dermatitis: A randomized controlled trial and quality of life assessment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS12137-TPS12137
Author(s):  
Karolina Mieczkowska ◽  
Alana Deutsch ◽  
Kosaku Shinoda ◽  
Johanna Daily ◽  
Nitin Ohri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Life Assessment ◽  
Radiation Dermatitis ◽  
Low Grade ◽  
Randomized Controlled ◽  
The Impact

TPS12137 Background: Radiation dermatitis (RD) can be therapy-limiting and detrimental to quality of life for cancer patients receiving radiation therapy (RT). Bacteria play an important role in many inflammatory dermatoses. In an observational clinical study, our group discovered that nasal colonization with bacteria, specifically with Staphylococcus aureus (SA), prior to RT was an independent predictor of higher-grade RD (grade ≥2). Higher-grade RD patients were also found to have more SA on the irradiated skin after treatment. If successful, bacterial decolonization could be a safe and cost-effective method to prevent RD. Methods: This is a randomized controlled trial assessing the efficacy of universal bacterial decolonization in preventing RD. Subject inclusion criteria include patients who are aged ≥ 18 years with a diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (≥ 15 fractions) with curative intent. Based on previous studies and power analyses, we plan to recruit a total of 80 patients. Patients in the control arm will be treated according to standard of care, including daily application of emollients and gentle bathing. In addition to standard of care, patients in the intervention arm will receive a decolonization regimen consisting of intranasal mupirocin ointment used twice daily and chlorhexidine wash used daily for 5 days prior to the initiation of RT and repeated for 5 days every other week throughout RT. Study evaluations for both groups will include bacterial cultures obtained via superficial swab from the nares, irradiated skin, and contralateral non-radiated skin performed at the beginning, middle, and end of RT. Additionally, standardized photographs of the skin at the radiated site will be performed prior to and at the completion of RT, which will be graded by a dermatologist blinded to study arm. Lastly, at identical timepoints, each patient will complete the SKINDEX-16 questionnaire, a validated quality of life (QoL) assessment. The primary endpoint is development of grade ≥ 2 RD, as compared to low-grade RD (grade 0-1), during RT. The secondary endpoint includes the impact of bacterial decolonization on QoL. Pearson’s chi square or Fisher’s exact tests will be used to compare the incidence rates of higher-grade RD between the interventional arm and control arm to assess if the intervention is associated with a lower incidence rate of higher-grade RD. Paired t-tests will be used to compare the QoL score change from baseline to after RT between the two arms. Linear regression models will be used in both analyses to adjust for covariates. Clinical trial information: NCT03883828.

scholarly journals Wolfberry Consumption with a Healthy Dietary Pattern Lowers Oxidative Stress and Improves Carotenoids Status in Middle-Aged and Older Adults: A Randomized Controlled Trial

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 79-79
Author(s):  
Darel Wee Kiat Toh ◽  
Wan Yee Lee ◽  
Hanzhang Zhou ◽  
Clarinda Sutanto ◽  
Delia Pei Shan Lee ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Dietary Pattern ◽  
Controlled Trial ◽  
Middle Aged ◽  
Randomized Controlled ◽  
Dietary Counselling ◽  
The Impact ◽  
Healthy Dietary Pattern

Abstract Objectives The incorporation of zeaxanthin rich wolfberry (Lycium barbarum) into a healthy dietary pattern may augment its antioxidant effects although evidence evaluating whole fruits is lacking. The objectives of this study are to (1) investigate the impact of dietary counselling, either with or without whole dried wolfberry on oxidative stress status in middle-aged and older Singaporean adults and (2) delineate underlying mechanisms by examining associations with the corresponding changes in carotenoids status. Methods In this 16-week, parallel design randomized controlled trial, 40 subjects (29 F, 11 M; aged 50 to 64 y) received dietary counselling to follow a healthy dietary pattern. Compared to the control group (CG, n = 18), the wolfberry group (WG, n = 22) additionally cooked and consumed 15 g/d whole dried wolfberry with their main meals. Biomarkers of oxidative stress (plasma malondialdehyde (MDA) by thiobarbituric acid reactive substance assay and 8-isoprostanes by ELISA) were measured at baseline and week 16. Plasma and dietary carotenoids analyzed by HPLC and 3-day food records respectively were measured at baseline, week 8 and week 16 while skin carotenoids status (SCS) by resonance Raman spectroscopy was assayed every 4 weeks. Results Plasma 8-isoprostanes showed a time effect (P &lt; 0.05), attributed to the marked decline in the WG only (WG: −19.0 ± 43.6 ng/L; CG: −7.7 ± 38.7 ng/L, mean ± SD) though no effect was observed for MDA. A significant interaction effect (P &lt; 0.001), driven by higher plasma zeaxanthin (WG: +0.08 ± 0.13 nmol/L; CG: −0.03 ± 0.05 nmol/L) and SCS (WG: +4242 ± 4938 a.u.; CG: +1713 ± 5921 a.u.) was observed in the WG with a marked increase evident from week 8 onwards although concentrations of the other plasma carotenoids were maintained. Moreover, the change value for plasma zeaxanthin in the WG was inversely associated with the corresponding changes in plasma 8-isoprostanes (−0.21 (−0.43, 0.00) ng/µmol, regression coefficient (95% CI); P = 0.05). This same association was absent in the CG. Conclusions Consuming wolfberry with a healthy dietary pattern attenuates oxidative stress in middle-aged and older adults and this may be attributed to the rich zeaxanthin content in wolfberry. Funding Sources National University of Singapore Ministry of Education, Singapore Agency for Science, Technology and Research.

scholarly journals Home ovulation test use and stress during subfertility evaluation: Subarm of a randomized controlled trial

2019 ◽  
Vol 15 ◽  
pp. 174550651983836
Author(s):  
Sarah Weddell ◽  
Georgina L Jones ◽  
Sheila Duffy ◽  
Cameron Hogg ◽  
Sarah Johnson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Confidence Interval ◽  
Average Length ◽  
Controlled Trial ◽  
Test Group ◽  
Well Being ◽  
Control Group ◽  
Psychological Well Being ◽  
Randomized Controlled ◽  
The Impact

Objectives: A prospective, randomized controlled trial in women seeking to conceive examined the impact of using ovulation tests on self-reported levels of stress, psychological well-being, and quality of life in women with unexplained infertility. Method: The test group used a home ovulation test to detect the day of ovulation, whereas the control group were provided with a predicted day of ovulation based on the average length of menstrual cycle reported during study recruitment. Volunteers collected their first morning urine samples to evaluate biochemical levels of stress (urinary cortisol and estrone-3-glucouronide) and completed questionnaires over two complete menstrual cycles. Results: Overall, the use of digital ovulation tests by sub-fertile women under medical care had negligible negative effects and no detectable positive benefit on psychological well-being, according to multiple measurements of stress by questionnaire and biochemical markers. No significant differences were found between groups for all stress measures at the various study time points, except in relation to “couple concordance” where the test group scored much higher than the control group (mean difference at end of study was 21.25 (95% confidence interval: 9.25, 33.25; P = 0.0015)). The maximum difference in log cortisol: creatinine ratio between the test and control groups was −0.28 (95% confidence interval: −0.69, 0.13). Conclusions: These results do not support propositions that using digital ovulation tests can cause stress in women trying to conceive.

scholarly journals Challenges faced and lessons learned A multi-component prospective memory training program for Malaysian older adults

2018 ◽  
Vol 12 (2) ◽  
pp. 189-195
Author(s):  
Azin Farzin ◽  
Rahimah Ibrahim ◽  
Zainal Madon ◽  
Hamidon Basri
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Prospective Memory ◽  
Controlled Trial ◽  
Practical Method ◽  
Lessons Learned ◽  
Memory Training ◽  
Cultural Issues ◽  
Randomized Controlled ◽  
The Impact

Abstract The surrounding circumstances and environments of Malaysian older adults could make conducting interventions (mainly in terms of clinical or randomized controlled trials) a challenge. Working with older adults and facing cultural issues could be challenging. Objective: This paper illustrates a significant perspective of some of the challenges faced while conducting a randomized controlled trial exploring the impact of a multi-component intervention that included strategy- and process-based prospective memory (PM) training among Malaysian older adults. Methods: The current study was a randomized controlled trial (RCT) and therefore the challenges were presented in accordance with the CONSORT statement style. Results: A discussion on how these issues were addressed is provided. Conclusion: Some suggestions were presented to help researchers plan and create interventions for similar studies and to support a practical method of addressing all related challenges.

scholarly journals Randomized Controlled Trial to Determine the Impact of Probiotic Administration on Colonization With Multidrug-Resistant Organisms in Critically Ill Patients

2015 ◽  
Vol 36 (12) ◽  
pp. 1451-1454 ◽  
Author(s):  
Jennie H. Kwon ◽  
Kerry M. Bommarito ◽  
Kimberly A. Reske ◽  
Sondra M. Seiler ◽  
Tiffany Hink ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Lactobacillus Rhamnosus ◽  
Standard Of Care ◽  
Multidrug Resistant ◽  
Resistant Organism ◽  
Randomized Controlled ◽  
Multidrug Resistant Organisms ◽  
The Impact

This was a randomized controlled pilot study of Lactobacillus rhamnosus GG versus standard of care to prevent gastrointestinal multidrug-resistant organism colonization in intensive care unit patients. Among 70 subjects, there were no significant differences in acquisition or loss of any multidrug-resistant organisms (P>.05) and no probiotic-associated adverse events.Infect. Control Hosp. Epidemiol. 2015;36(12):1451–1454

scholarly journals Predictive analytics and tailored interventions improve clinical outcomes in older adults: a randomized controlled trial

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Sara Bersche Golas ◽  
Mariana Nikolova-Simons ◽  
Ramya Palacholla ◽  
Jorn op den Buijs ◽  
Gary Garberg ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Predictive Analytics ◽  
Controlled Trial ◽  
Stepped Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
The Impact

AbstractThis study explored the potential to improve clinical outcomes in patients at risk of moving to the top segment of the cost acuity pyramid. This randomized controlled trial evaluated the impact of a Stepped-Care approach (predictive analytics + tailored nurse-driven interventions) on healthcare utilization among 370 older adult patients enrolled in a homecare management program and using a Personal Emergency Response System. The Control group (CG) received care as usual, while the Intervention group (IG) received Stepped-Care during a 180-day intervention period. The primary outcome, decrease in emergency encounters, was not statistically significant (15%, p = 0.291). However, compared to the CG, the IG had significant reductions in total 90-day readmissions (68%, p = 0.007), patients with 90-day readmissions (76%, p = 0.011), total 180-day readmissions (53%, p = 0.020), and EMS encounters (49%, p = 0.006). Predictive analytics combined with tailored interventions could potentially improve clinical outcomes in older adults, supporting population health management in home or community settings.

scholarly journals Change in Dysfunctional Sleep-Related Beliefs is Associated with Changes in Sleep and Other Health Outcomes Among Older Veterans With Insomnia: Findings From a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yeonsu Song ◽  
Monica R Kelly ◽  
Constance H Fung ◽  
Joseph M Dzierzewski ◽  
Austin M Grinberg ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Severity Index ◽  
Sleep Diary ◽  
Daytime Functioning ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Cognitive behavioral therapy for insomnia (CBTI) targets changing dysfunctional sleep-related beliefs. The impact of these changes on daytime functioning in older adults is unknown. Purpose We examined whether changes in sleep-related beliefs from pre- to post-CBTI predicted changes in sleep and other outcomes in older adults. Method Data included 144 older veterans with insomnia from a randomized controlled trial testing CBTI. Sleep-related beliefs were assessed with the Dysfunctional Beliefs and Attitudes about Sleep-16 (DBAS-16, subscales: Consequences, Worry/Helplessness, Sleep Expectations, Medication). Outcomes included sleep diary variables, actigraphy-measured sleep efficiency, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), Flinders Fatigue Scale (FFS), Patient Health Questionnaire-9, and health-related quality of life. Analyses compared slope of change in DBAS subscales from baseline to posttreatment between CBTI and control, and assessed the relationship between DBAS change and the slope of change in outcomes from baseline to 6 months. Results Compared to controls, the CBTI group demonstrated stronger associations between improvement in DBAS-Consequences and subsequent improvement in PSQI, ISI, ESS, and FFS. The CBTI group also demonstrated stronger associations between improvement in DBAS-Worry/Helplessness and subsequent improvements in PSQI, ISI, and FFS; improvements in DBAS-Medication and PSQI; and improvements in DBAS-Sleep Expectations and wake after sleep onset (sleep diary) and FFS (all p &lt; .05). Conclusions Significant reduction in dysfunctional sleep-related beliefs following CBTI in older adults predicted improvement in several outcomes of sleep and daytime functioning. This suggests the importance of addressing sleep-related beliefs for sustained improvement with CBTI in older veterans. Trial Registration ClinicalTrials.gov Identifier: NCT00781963.

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