scholarly journals Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial

10.2196/15969 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e15969
Author(s):  
Simon S Spahrkäs ◽  
Anne Looijmans ◽  
Robbert Sanderman ◽  
Mariët Hagedoorn
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
The United States ◽  
Waiting List ◽  
Self Management ◽  
Face To Face ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Number Of Patients

Background Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. Objective The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. Methods The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. Results Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. Conclusions This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF. Trial Registration Netherlands Trial Register NL6642; https://www.trialregister.nl/trial/6642. International Registered Report Identifier (IRRID) DERR1-10.2196/15969

scholarly journals Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Esther du Pon ◽  
Nanne Kleefstra ◽  
Frits Cleveringa ◽  
Ad van Dooren ◽  
Eibert R. Heerdink ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Online Platform ◽  
Randomized Controlled ◽  
Number Of Patients

Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients’ self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) (X21=0.58; p=0.45), and the number of patients who logged on at least once (platform users) (X21=0.46; p=0.50). In addition, no differences were found between the groups in the type of users—patients who logged on twice or more (active users) or patients who logged on once (nonactive users) (X21=0.56; p=0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.

Neonatology Needs Help

PEDIATRICS ◽  
1992 ◽  
Vol 89 (1) ◽  
pp. 158-158
Author(s):  
Jerold F. Lucey
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Clinical Research ◽  
Controlled Trial ◽  
The United States ◽  
Bad News ◽  
Good News ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Prospective Randomized Controlled Trial

I just reviewed the April 1991 issue of Pediatric Research which contains the APS-SPR abstracts. You can't help but notice that neonatology is the most active area of clinical research. Of the 2257 manuscripts submitted, at least 1119 can be classified as neonatal. There are now more than 2500 board-certified neonatologists in the United States. We certainly get high marks for producing abstracts. That's the good news. The bad news, I think, is how trivial, repetitive, and fruitless some of these studies seem to be. I stopped counting when I reached 20 abstracts which ended with the phrase "but of course this study needs to be repeated on a larger number of patients in a prospective randomized controlled trial."

scholarly journals Video consultation as an adequate alternative to face-to-face consultations in CPAP use for patients with obstructive sleep apnea: a Randomized Controlled Trial. (Preprint)

2020 ◽  
Author(s):  
L. Kooij ◽  
P. J. E. Vos ◽  
A. Dijkstra ◽  
E. A. Roovers ◽  
W. H. van Harten
Keyword(s):  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Outcome Expectancies ◽  
Self Management ◽  
Face To Face ◽  
Randomized Controlled ◽  
Cognitive Components ◽  
Video Consultation ◽  
Over Time

BACKGROUND The effectiveness of Continuous Positive Airway Pressure (CPAP) is dependent on the degree of use, so adherence is essential. Cognitive components (e.g. self-efficacy) are found to be important in predicting CPAP use. Telemedicine interventions are increasingly used to support self-management in different chronic diseases. Especially video consultation is a promising way of supporting OSA patients, and may be beneficial during treatment. So far video consultation is seldom evaluated through thorough controlled research, with only a limited number of outcomes assessed. OBJECTIVE To evaluate the effects of video consultation versus face-to-face consultation for patients with OSA on patients’ CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients’ and professionals’ satisfaction. METHODS A Randomized Controlled Trial was conducted with an intervention- (video consultations) and a usual care group (face-to-face consultations) with CPAP use assessments after 4, 12 and 24 weeks. Patients with confirmed OSA (AHI > 15), requiring CPAP treatment, no history of CPAP treatment, having access to a tablet/smartphone and proficiency of the Dutch language were included in the study. Patients completed questionnaires at baseline and after one month on self-efficacy, risk perception, outcome expectancies (using Self-Efficacy Measure for Sleep Apnea), expectations and experiences with video consultations (covering constructs of the Unified Theory of Acceptance and Use of Technology) and satisfaction. RESULTS In both groups CPAP use decreased over time (P=.01) similarly. No significant difference in change over time (week 4, 12 and 24) between groups was found for CPAP use (P interaction term P=.54). Self-efficacy appeared to have a statistically significant effect on CPAP use in both groups (P=.001), regardless of the intervention arm (P=.27). Patients in both groups were satisfied with the consultations and rated these respectively with an 8.4 and 8.3. The experiences with video consultation were positive, e.g. it did not cost patients effort (92%), they reported to have skills to use it (95%) and they intended to keep using it (95%). All nurses were satisfied with the quality of the sound, video and privacy and security. However, they recommended to use video consultation only in follow-up. CONCLUSIONS To our knowledge, this is the first Randomized Controlled Trial that examined the effects of video consultation on CPAP use over time for newly diagnosed OSA patients in combination with cognitive components and technology acceptance. The findings of this research suggest that, for patients starting CPAP, video consultation can preferably be used in combination with an initial face-to-face consultation and especially for patients with high levels of self-efficacy. Future research should focus on blended care approaches in which self-management and especially self-efficacy is receiving greater emphasis.

scholarly journals Therapeutic Education and Physical Activity to Support Self-management of Cancer-related Fatigue in Hematologic Cancer Patients: Protocol of a Feasibility Randomized Controlled Trial

2020 ◽  
Vol 19 ◽  
pp. 153473542096983
Author(s):  
Monica Denti ◽  
Monia Allisen Accogli ◽  
Stefania Costi ◽  
Stefania Fugazzaro
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hematologic Malignancies ◽  
Therapeutic Education ◽  
Self Management ◽  
Convenience Sample ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Hematologic Cancer

Introduction Hematologic malignancies account for nearly 8% of new cancer diagnosis in Italy. Cancer-related fatigue (CRF) is one of the most distressing symptoms reported by patients with cancer. As CRF has a multifactorial etiology, physical activity and therapeutic education may be beneficial for managing CRF, both during and after cancer treatment. However, there is a lack of evidence specific to hematologic malignancies. This paper describes the protocol of a feasibility study on Therapeutic Education and Physical Activity (TEPA) intervention to support self-management of CRF in patients with hematologic malignancies. Methods TEPA was addressed to newly diagnosed adult individuals with hematologic malignancy able to take part in a rehabilitation programme at the AUSL-IRCCS of Reggio Emilia. The protocol was developed in 2 phases. Phase I was an observational cohort study involving a convenience sample of 10 participants with the aim to evaluate the feasibility of the assessment schedule and to register longitudinal clinical data regarding CRF (FACIT-F), psychologic distress (NCCN Distress Thermometer), QoL (EORTC QLQ-C30), physical performance (TUG and 6MWT) and habitual level of physical activity during first months after diagnosis. Phase II (underway) is a feasibility randomized controlled trial (TEPA) involving a convenience sample of 40 participants and comparing 2 parallel active interventions (Therapeutic Education versus Therapeutic Education and Physical Activity) on top of usual care. The primary aim is to estimate the feasibility of TEPA, measured by the adherence rate to the intervention. Secondary aims are: to estimate the effect size of TEPA in terms of changes in CRF, psychological distress, QoL, physical performance and habitual level of physical activity (measured as in Phase I); to collect patient satisfaction, perception of usefulness of the TEPA intervention and data on long-term adherence to an active lifestyle. Data are collected in both phases at the time of diagnosis and then at 1-, 3- (completion of intervention) and 7-month follow-up. Discussion Data on feasibility and effect size of TEPA will be analyzed upon completion of Phase II, allowing us to design a large, adequately powered RCT to verify the effectiveness of this intervention on CRF management in patients with hematologic cancer. Trial registration: clinicaltrials.gov; Trial registration number: NCT03403075

scholarly journals Beating cancer‐related fatigue with the Untire mobile app: Results from a waiting‐list randomized controlled trial

2020 ◽  
Vol 29 (11) ◽  
pp. 1823-1834
Author(s):  
Simon Sebastian Spahrkäs ◽  
Anne Looijmans ◽  
Robbert Sanderman ◽  
Mariët Hagedoorn
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mobile App ◽  
Waiting List ◽  
Randomized Controlled ◽  
Cancer Related Fatigue

scholarly journals Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: A non-inferiority randomized controlled trial

SLEEP ◽  
2021 ◽  
Author(s):  
Josée Savard ◽  
Hans Ivers ◽  
Marie-Hélène Savard ◽  
Charles M Morin ◽  
Aude Caplette-Gingras ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Cancer Patients ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Stepped Care ◽  
Sleep Diary ◽  
Face To Face ◽  
Randomized Controlled ◽  
Care Approach

Abstract Study Objectives Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this non-inferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I). Methods A total of 177 cancer patients were randomized to: 1) StanCBT-I (6 face-to-face CBT-I sessions; n=59); or 2) StepCBT-I (n=118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n=65), while those with a more severe insomnia received 6 face-to-face CBT-I sessions (n=53). In both cases, patients could receive up to 3 booster sessions of CBT-I if they still had insomnia symptoms following this first step. Results Results indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that were not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps<.001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue and quality of life scores. Conclusion(s) The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.

scholarly journals Zhengyuan capsule for the treatment of cancer-related fatigue in lung cancer patients undergoing operation: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Zhouji Zhang ◽  
Ming Zhang ◽  
Xiaoting Wu ◽  
Qing Cui ◽  
Yijun Guo
Keyword(s):  
Lung Cancer ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Treatment Guidelines ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Lung Cancer Patients ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Severity Scores

Abstract Background: Cancer-related fatigue (CRF) is one of the most common and painful symptoms in patients with lung cancer undergoing treatment with operation, affecting patients’ physical, psychological, family and social functions as well as their quality of life. However, there is very little evidence for treatment guidelines at home and abroad. Traditional Chinese Medicine (TCM) has been proved to improve the symptoms of general weakness and shown to be beneficial to cancer patients’ recovery. TCM treatment should be based on syndrome differentiation. Aiming at the CRF, we should focus on bolstering the deficiency while simultaneously attacking and reinforcing it. This trial preliminarily evaluated the efficacy and safety of Zhengyuan capsule for CRF in lung cancer patients undergoing operation. Methods/design: The single center clinical study is a two-group, double-blind, prospective, placebo-controlled, randomized controlled trial (RCT) designed to assess the efficacy and safety of Zhengyuan capsule for CRF in lung cancer patients undergoing operation. Eligible participants will randomly divided into two groups: a treatment group receiving a 8-week Zhengyuan capsule regimen therapy and a control group receiving a 8-week placebo capsule regimen therapy. The main efficacy indicator is fatigue, assessed using severity scores from the Cancer Fatigue Scale(CFS) measurement system. Secondary efficacy measures include fatigue which assessed using severity scores from the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, TCM syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient’s pulmonary functionality and adverse events (AEs). Evaluation will be carried out at the screening period, baseline, the middle of the intervention and the end of the intervention, respectively. Discussion: Experimental results of Zhengyuan capsule can guide the improvement of CRF and provide evidences that Zhengyuan capsule is effective and safe in lung cancer patients undergoing operation. The data can be imported into the management and treatment guidelines of CRF for patients with lung cancer undergoing operation throughout China nationwide. Trial registration: Chinese Clinical Trial Registry (chictr.org.cn), ChiCTR1900022712/YZJ-TCM-ZYJN-02. Registered on 23 April 2019.

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