scholarly journals The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors (Preprint)

2021 ◽  
Author(s):  
Nicholas J Hulbert-Williams ◽  
Monica Leslie ◽  
Lee Hulbert-Williams ◽  
Bogda Koczwara ◽  
Eila K Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Research Network ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. <i>Finding My Way</i> (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that <i>FMW</i> is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. OBJECTIVE This study aims to adapt the Australian <i>FMW</i> website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of <i>FMW UK</i> against a treatment-as-usual waitlist control. METHODS To an extent, our trial design replicates the existing Australian randomized controlled trial of <i>FMW.</i> Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, <i>FMW UK</i> and suggestions for future improvements<i>.</i> RESULTS The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of <i>FMW UK.</i> Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the <i>Improving Communication</i> and <i>Sexuality and Intimacy</i> content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. CONCLUSIONS Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the <i>FMW</i> trial in the UK setting, content updating was required. If <i>FMW UK</i> now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/31976

scholarly journals The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

10.2196/31976 ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. e31976
Author(s):  
Nicholas J Hulbert-Williams ◽  
Monica Leslie ◽  
Lee Hulbert-Williams ◽  
Bogda Koczwara ◽  
Eila K Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Research Network ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact

Background Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. Objective This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. Methods To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. Results The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. Conclusions Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 International Registered Report Identifier (IRRID) DERR1-10.2196/31976

Short-term effectiveness of a web-based tailored intervention for cancer survivors on quality of life, anxiety, depression, and fatigue: randomized controlled trial

2016 ◽  
Vol 26 (2) ◽  
pp. 222-230 ◽  
Author(s):  
Roy A. Willems ◽  
Catherine A. W. Bolman ◽  
Ilse Mesters ◽  
Iris M. Kanera ◽  
Audrey A. J. M. Beaulen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Tailored Intervention ◽  
Short Term ◽  
Web Based ◽  
Randomized Controlled ◽  
Anxiety Depression

Effects of Web-Based Interventions on Physical Activity and Quality of Life in Colorectal Cancer Survivors: Systematic Review and Meta-Analysis (Preprint)

2021 ◽  
Author(s):  
Ching-Ching Su ◽  
Su-Er Guo ◽  
Ya-Wen Kuo
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
Colorectal Cancer Survivors

BACKGROUND Approximately 80% of colorectal cancer survivors have at least one comorbidity. Physical activity (PA) can mitigate the adverse effects of disease treatment, reduce patients’ mortality rate, and improve their quality of life (QoL). However, colorectal cancer survivors generally engage in insufficient PA. The present study proposed that web-based interventions can assist patients with colorectal cancer in improving their PA behavior to induce health-promoting effects, thus positively influencing their QoL. OBJECTIVE To perform a systematic literature review, to employ web-based interventions to improve the PA behavior and QoL of colorectal cancer survivors, and to assess the quality of research articles. METHODS A systematic literature search was performed based on the PRISMA guidelines to compile literature on the influence of web-based interventions on the PA activity and QoL of colorectal cancer survivors. Electronic databases (PubMed, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials, and CEPS) were searched up until July 2020. Additionally, the researchers manually searched for journal articles referenced in the collected literature. Literature quality assessment and data extraction were performed by 3 researchers individually using the Joanna Briggs Institute appraisal tool. RESULTS Among the 438 searched studies, 6 published between 2009 and 2019 met the inclusion criteria. Of these studies, 4 had adopted randomized controlled trial designs and 2 had employed one-group pretest–posttest designs. The collected literature exhibited risk of bias to varying degrees. The overall outcomes revealed that after 6 months of web-based interventions, participants’ performance in PA indicators improved significantly (P = .03). Additionally, a comparison conducted using the European Organization for Research and Treatment of Cancer Quality of Life scale revealed no significant differences between the experiment group, which received 3 months of intervention, and the control group (P = .24). However, a comparison conducted using the Functional Assessment of Cancer Therapy-Colorectal questionnaire indicated a significant difference in QoL indicators between groups (P = .01). CONCLUSIONS Web-based interventions are conducive to improving the PA behavior and QoL of colorectal cancer survivors. Because intervention outcomes may differ based on the intervention time and the assessment tools used, more randomized controlled trial–based clinical research is required to provide suggestions for clinical practice.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

Web-Based Intervention to Improve Implantable Cardioverter Defibrillator Patients’ Shock-Related Anxiety and Quality of Life: A Randomized Controlled Trial

2017 ◽  
Vol 28 (2) ◽  
pp. 150-164 ◽  
Author(s):  
Tuğba Yardımcı ◽  
Hatice Mert
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Implantable Cardioverter Defibrillator ◽  
Controlled Trial ◽  
Web Based ◽  
Cardioverter Defibrillator ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Shock Anxiety

In spite of its effectiveness, implantable cardioverter defibrillator (ICD) patients face psychological problems such as shock-related anxiety due to device shocks. The aim of this study was to evaluate whether a web-based intervention program for ICD patients would reduce shock-related anxiety and improve quality of life compared with usual care. This was a randomized controlled trial study including a total of 76 patients. Data were collected using Turkish versions of the Florida Shock Anxiety Scale and Short Form Health Survey (SF-36) at 0 (baseline), 3, and 6 months. Following intervention, there was a significant decrease in shock anxiety levels of patients and a statistically significant increase in social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36. While no statistically significant difference was found between groups in terms of summary scores of SF-36, our results suggest that web-based interventions can be useful for ICD patients.

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