scholarly journals 08 / A RANDOMISED CONTROLLED TRIAL OF PSYCHO-EDUCATIONAL INTERVENTIONS FOR REDUCING UNCERTAINTY AND ANXIETY, AND IMPROVING SEXUAL FUNCTIONING AMONG GYNAECOLOGICAL CANCER PATIENTS IN HONG KONG

Author(s):  
Ka Ming Chow
BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038351
Author(s):  
Xue Weng ◽  
Man Ping Wang ◽  
Ho Cheung William Li ◽  
Yee Tak Derek Cheung ◽  
Ching Yin Lau ◽  
...  

IntroductionEvidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.Methods and analysisThis ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow‐ups at 1, 2, 3 and 6 months after randomisation. We aim to enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong. All participants receive Ask, Warn, Advise, Refer, Do-it-again (AWARD) guided advice and a self-help booklet at baseline. Additionally, participants in the intervention group receive an offer of referral to smoking cessation services at baseline and a small financial incentive (HK$300≈US$38) contingent on using any of such services within 3 months. The primary outcomes are bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10 ng/mL) at 3 and 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services at 3 and 6 months. Intention-to-treat approach and regression models will be used in primary analyses.Ethics and disseminationThis protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-318). The results of this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences.Trial registration numberClinicalTrials.gov Registry NCT03565796.


PLoS ONE ◽  
2013 ◽  
Vol 8 (5) ◽  
pp. e63271 ◽  
Author(s):  
Sietske J. Tamminga ◽  
Jos H. A. M. Verbeek ◽  
Monique M. E. M. Bos ◽  
Guus Fons ◽  
Jos J. E. M. Kitzen ◽  
...  

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
T. X. Wong ◽  
S. T. Chen ◽  
S. H. Ong ◽  
S. Shyam ◽  
P. Kandasami ◽  
...  

Abstract Background While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer. Methods Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate. Discussion This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes. Trial registration ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered


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