NCT06754722 · 5 Point App, Inc.
Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
Primary outcome measures
Fatigue self-report 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have cancer or have been treated for cancer;
- at least a moderate level of fatigue (greater than 4 on a 0 to 10 Likert-type scale);
- able to read and speak in English;
- age 18 years or older; Android 11 or later),
- adequate hearing, vision, and functional ability to see, hear and use the app and participate in interviews,
- willing to wear a provided Fitbit 24/7 (except when charging) throughout the study.
Exclusion criteria
- recent history of easy bruising or bleeding
- previous use of the EnergyPoints app. Note: The functional ability questions will exclude anyone who is too sick to participate due to life-limiting disease.
Where
- New York, New York
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations