scholarly journals Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned

2011 ◽  
Vol 8 (3) ◽  
pp. 298-310 ◽  
Author(s):  
Jennifer Steel ◽  
David A Geller ◽  
Allan Tsung ◽  
J Wallis Marsh ◽  
Mary Amanda Dew ◽  
...  
2019 ◽  
Vol 70 (3) ◽  
pp. 219-224 ◽  
Author(s):  
Amy M. Kilbourne ◽  
Katherine M. Prenovost ◽  
Celeste Liebrecht ◽  
Daniel Eisenberg ◽  
Hyungjin Myra Kim ◽  
...  

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Onur M. Orun ◽  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Ellis Morgan ◽  
Mohana Karlekar ◽  
...  

Abstract Background The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. Methods and design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. Results The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. Trial registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018


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