Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors

Condition(s) studied

Investigational drug(s) / intervention(s)

App to guide self-acupressure: The intervention is delivered via a mobile health app. EnergyPoints app, on iOS and Android, educates and guides use of acupressure rituals to self-manage fatigue and sleep disturbances. The intervention involves using the app daily for 6 weeks. A follow-along format guides correct point stimulation for two acupressure rituals (stimulating and relaxing). The app synchronizes symptom self-reports with fitness tracker (e.g., an Apple Watch or Fitbit) sleep and activity data, allowing evaluation of response to acupressure. The dashboard provides options to tailor the rituals and pressing time (½, 1 or 2 min. per point) according to symptom experience, lifestyle, and schedule. Individuals can choose to use enhancements such as aromatherapy (including an instructional safety video), relaxing music, and/or visuals during each ritual and connect with other users via the social engagement feature.

Study 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

Eligibility

Primary outcome measure(s)

• Fatigue self-report 1 — Baseline and Weekly for 7 or 13 weeks
  Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue 7a, a standardized measure of fatigue, yields a T score. A T score is a standardized measure on a 0 to 100 scale. The mean is 50 and SD is 10. Higher results indicate more fatigue.
• Fatigue self-report 2 — Daily for 7 or 13 weeks
  Patient Reported Outcome Measurement Information System (PROMIS) single item of fatigue intensity on a 1 to 5 scale. A higher score indicates more fatigue.
• Sleep Self-Report 1 — Baseline and Weekly for 7 or 13 weeks
  Patient Reported Outcome Measurement Information System (PROMIS) Sleep Disturbances 8b, a standardized measure of sleep, yields a T score. A T score is a standardized measure on a 0 to 100 scale. The mean is 50 and SD is 10. Higher results indicate more sleep disturbance.
• Sleep Self-Report 2 — Daily for 7 or 13 weeks
  Single item measure of overall sleep quality on a scale of 1 to 5. A higher score indicates better sleep quality.
• Global Health — Baseline and Weekly for 7 or 13 weeks
  Patient Reported Outcome Measurement Information System (PROMIS) Global Health V1.2.10, a standardized measure of health and functioning, includes a physical health and mental health subscale, yielding a T score for each. A T score is a standardized measure on a 0 to 100 scale. The mean is 50 and SD is 10. Higher results indicate better physical or mental health.
• Measures of Activity: Step Count — Daily for 7 or 13 weeks
  Fitbit is worn 24/7 and data are synched via the EnergyPoints app. The measure is number of steps in a 24 hour period and the range is 0 to maximum steps.
• Measures of Sleep: Sleep efficiency — Daily for 7 or 13 weeks
  Fitbit is worn 24/7 and data are synched via the EnergyPoints app. Sleep efficiency is calculated by the percent of time asleep while in bed.

Trial sites (1)