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

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

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A mobile app for social anxiety disorder: A three-arm randomized controlled trial comparing mobile and PC-based guided self-help interventions.

Journal of Consulting and Clinical Psychology ◽

10.1037/ccp0000301 ◽

2018 ◽

Vol 86 (6) ◽

pp. 493-504 ◽

Cited By ~ 22

Author(s):

Timo Stolz ◽

Ava Schulz ◽

Tobias Krieger ◽

Alessia Vincent ◽

Antoine Urech ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Anxiety Disorder ◽

Social Anxiety ◽

Social Anxiety Disorder ◽

Controlled Trial ◽

Mobile App ◽

Randomized Controlled ◽

Self Help

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A Randomized Controlled Trial of Home-Based Exercise for Cancer-Related Fatigue in Women During and After Chemotherapy With or Without Radiation Therapy

Cancer Nursing ◽

10.1097/ncc.0b013e3181ddc58c ◽

2010 ◽

Vol 33 (4) ◽

pp. 245-257 ◽

Cited By ~ 63

Author(s):

Marylin J. Dodd ◽

Maria H. Cho ◽

Christine Miaskowski ◽

Patricia L. Painter ◽

Steven M. Paul ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Radiation Therapy ◽

Controlled Trial ◽

Randomized Controlled ◽

Cancer Related Fatigue ◽

Home Based

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Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2005.01.271 ◽

2005 ◽

Vol 23 (25) ◽

pp. 6027-6036 ◽

Cited By ~ 102

Author(s):

Patsy Yates ◽

Sanchia Aranda ◽

Maryanne Hargraves ◽

Bev Mirolo ◽

Alexandra Clavarino ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Randomized Controlled Trial ◽

Functional Assessment ◽

Controlled Trial ◽

Intervention Group ◽

Randomized Controlled ◽

Cancer Related Fatigue ◽

Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

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