scholarly journals A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabelle Suvaal ◽  
Susanna B. Hummel ◽  
Jan-Willem M. Mens ◽  
Helena C. van Doorn ◽  
Wilbert B. van den Hout ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Sexual Functioning ◽  
Controlled Trial ◽  
Gynaecological Cancer ◽  
Optimal Care ◽  
Sexual Rehabilitation ◽  
Randomized Controlled ◽  
Rehabilitation Intervention ◽  
The Cost

Abstract Background Sexual problems are frequently reported after treatment with radiotherapy (RT) for gynaecological cancer (GC), in particular after combined external beam radiotherapy and brachytherapy (EBRT+BT). Studies demonstrate that psychosexual support should include cognitive behavioural interventions and involvement of the patient’s partner, if available. Therefore, we developed a nurse-led sexual rehabilitation intervention, including these key components. The intervention was previously pilot-tested and results demonstrated that this intervention improves women’s sexual functioning and increases dilator compliance. The objective of the current study is to investigate the (cost-)effectiveness of the intervention compared to optimal care as usual (CAU). We expect that women who receive the intervention will report a statistically significant greater improvement in sexual functioning and – for women who receive EBRT+BT – higher compliance with dilator use, from baseline to 12 months post-RT than women who receive optimal care as usual (CAU). Methods/design The intervention is evaluated in the SPARC (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) study, a multicentre, randomized controlled trial (RCT). The primary endpoint is sexual functioning. Secondary outcomes include body image, fear of sexual activity, sexual-, treatment-related- and psychological distress, health-related quality of life and relationship satisfaction. A cost-effectiveness analysis (CEA) will be conducted in which the costs of the intervention will be related to shifts in other health care costs and the impact on patient outcome. The study sample will consist of 220 women with GC treated with RT in specialized GC treatment centres (N = 10). Participants are randomized to either the intervention- or CAU control group (1:1), and within each centre stratified by type of radiotherapy (EBRT+BT vs. EBRT only) and having a partner (yes/no). All women complete questionnaires at baseline (T1) and at 1, 3, 6, and 12 months post-RT (T2, T3, T4 and T5, respectively). Discussion There is a need to improve sexual functioning after RT for GC. This RCT will provide evidence about the (cost-)effectiveness of a nurse-led sexual rehabilitation intervention. If proven effective, the intervention will be a much needed addition to care offered to GC survivors and will result in improved quality of life. Trial registration ClinicalTrials.gov, NCT03611517. Registered 2 August 2018.

scholarly journals Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention

2020 ◽  
Vol 15 (9) ◽  
pp. 954-964 ◽  
Author(s):  
Vivian Fu ◽  
Mark Weatherall ◽  
Kathryn McPherson ◽  
William Taylor ◽  
Anna McRae ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Physical Component Summary ◽  
Short Form ◽  
Controlled Trial ◽  
Short Form 36 ◽  
Randomized Controlled ◽  
Rehabilitation Intervention ◽  
Related Quality

Background and purpose “Take Charge” is a novel, community-based self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. In a previous randomized controlled trial, a single Take Charge session improved independence and health-related quality of life 12 months following stroke in Māori and Pacific New Zealanders. We tested the same intervention in three doses (zero, one, or two sessions) in a larger study and in a broader non-Māori and non-Pacific population with stroke. We aimed to confirm whether the Take Charge intervention improved quality of life at 12 months after stroke in a different population and whether two sessions were more effective than one. Methods We randomized 400 people within 16 weeks of acute stroke who had been discharged to institution-free community living at seven centers in New Zealand to a single Take Charge session (TC1, n = 132), two Take Charge sessions six weeks apart (TC2, n = 138), or a control intervention (n = 130). Take Charge is a “talking therapy” that encourages a sense of purpose, autonomy, mastery, and connectedness with others. The primary outcome was the Physical Component Summary score of the Short Form 36 at 12 months following stroke comparing any Take Charge intervention to control. Results Of the 400 people randomized (mean age 72.2 years, 58.5% male), 10 died and two withdrew from the study. The remaining 388 (97%) people were followed up at 12 months after stroke. Twelve months following stroke, participants in either of the TC groups (i.e. TC1 + TC2) scored 2.9 (95% confidence intervals (CI) 0.95 to 4.9, p = 0.004) points higher (better) than control on the Short Form 36 Physical Component Summary. This difference remained significant when adjusted for pre-specified baseline variables. There was a dose effect with Short Form 36 Physical Component Summary scores increasing by 1.9 points (95% CI 0.8 to 3.1, p < 0.001) for each extra Take Charge session received. Exposure to the Take Charge intervention was associated with reduced odds of being dependent (modified Rankin Scale 3 to 5) at 12 months (TC1 + TC2 12% versus control 19.5%, odds ratio 0.55, 95% CI 0.31 to 0.99, p = 0.045). Conclusions Confirming the previous randomized controlled trial outcome, Take Charge—a low-cost, person-centered, self-directed rehabilitation intervention after stroke—improved health-related quality of life and independence. Clinical trial registration-URL http://www.anzctr.org.au . Unique identifier: ACTRN12615001163594

scholarly journals Determining the cost effectiveness of a smoke alarm give-away program using data from a randomized controlled trial

2005 ◽  
Vol 15 (5) ◽  
pp. 448-453 ◽  
Author(s):  
Laura Ginnelly ◽  
Mark Sculpher ◽  
Chris Bojke ◽  
Ian Roberts ◽  
Angie Wade ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Smoke Alarm ◽  
Randomized Controlled ◽  
Using Data ◽  
The Cost

scholarly journals The Cost-Effectiveness of specialized Nursing Interventions for people with Parkinson’s Disease: the NICE-PD study protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Danique LM Radder ◽  
Herma H Lennaerts ◽  
Hester Vermeulen ◽  
Thies van Asseldonk ◽  
Cathérine CS Delnooz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cost Effectiveness ◽  
Controlled Clinical Trial ◽  
Motor Symptoms ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Cost

Abstract Background Current guidelines recommend that every person with Parkinson’s disease (PD) should have access to Parkinson’s Disease Nurse Specialist (PDNS) care. However, there is little scientific evidence on the cost-effectiveness of PDNS care. This hampers wider implementation, creates unequal access to care and possibly leads to avoidable disability and costs. Therefore, we aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS compared to usual care (without PDNS) for people with PD in all disease stages. To gain more insight into the deployed interventions and their effects, a pre-planned subgroup analysis will be performed based on disease duration (diagnosis <5, 5-10, or >10 years ago). Methods We will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with PD that have not been treated by a PDNS over the past two years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to either care by a PDNS (who works according to a recent guideline on PDNS care) or usual care. We will use two co-primary outcomes: quality of life (measured with the Parkinson’s Disease Questionnaire-39) and motor symptoms (measured with the MDS-UPDRS part III). Secondary outcomes include non-motor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden and coping skills. Data will be collected after 12 months and 18 months by a blinded researcher. A healthcare utilization and productivity loss questionnaire will be completed every 3 months. Discussion The results of this trial will have an immediate impact on the current care of people with PD. We hypothesize that, by offering more patients access to PDNS care, quality of life will increase. We also expect healthcare costs to remain equal, as increases in direct medical costs (funding additional nurses) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care is warranted. Trial registration ClinicalTrials.gov: NCT03830190. Registered February 5, 2019 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03830190.

scholarly journals Cost-effectiveness and quality of life of a diet intervention postpartum: 2-year results from a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Lars Hagberg ◽  
Anna Winkvist ◽  
Hilde K Brekke ◽  
Fredrik Bertz ◽  
Else Hellebö Johansson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Diet Intervention ◽  
Randomized Controlled
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