Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors
5 Point App, Inc.
Summary
The purpose of the study is to evaluate whether EnergyPoints, a mobile phone health app that guides the participant to do self-acupressure, can decrease fatigue and improve sleep. Acupressure consists of applying physical pressure with fingers or a device to small locations on the body called acupoints. * The investigators will conduct this clinical trial remotely, allowing participants to use the app wherever they are. Participation will involve using the app daily while wearing a fitness tracker (a Fitbit) on the wrist, answering questions on the app and online, as well as completing a questionnaire and participating in an online interview at the end of the study. Participants will be assigned by chance to one of two groups. In both groups, participants will have a 1 week baseline week (Week 0) to get used to the Fitbit. Participants in the Immediate Group will start the 6 week trial of EnergyPoints immediately (Week 1). Participants in the Wait-List Group will be on a wait-list for 6 weeks during which time they will wear the Fitbit and answer online questions daily and weekly. At the end of the waiting period (week 7), these participants will begin the 6 week trial of EnergyPoints. * The risks to participating are minimal. There is a small risk of bruising or getting sore at a point where participants apply pressure. As with any mobile app, there is the possibility that electronic information could be viewed by third parties not involved in the study. The investigators cannot promise any benefits from participating in the study. However, it is possible that using acupressure might improve fatigue or sleep. Participants may use any other approaches to improve fatigue and sleep while in the study. A pilot study will be conducted first with 8 participants and 1 week periods (1 week baseline, 1 week waitlist, and 1 week intervention followed by an End of Study Questionnaire and Exit Interview
Description
This study from 5 Point App, Inc. aims to further test EnergyPoints-an app to help cancer survivors (people living with cancer both on and off treatment) administer acupressure to self-manage cancer-related fatigue (CRF) and sleep deficiency. The study aims to validate the effectiveness of the app on clinical outcomes in a decentralized clinical trial (DCT). The expert interdisciplinary team consists of scientists and clinical experts in acupressure, symptom management, and informatics; qualitative and quantitative analysts; software engineers and marketing experts. Up to 90% of patients rece…