Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors
1 other identifier
interventional
180
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 1, 2025
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
January 16, 2026
January 1, 2026
1.7 years
December 19, 2024
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Fatigue self-report 1
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.
Baseline and Weekly for 7 or 13 weeks
Fatigue self-report 2
Patient Reported Outcome Measurement Information System (PROMIS) single item of fatigue intensity on a 1 to 5 scale. A higher score indicates more fatigue.
Daily for 7 or 13 weeks
Sleep Self-Report 1
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.
Baseline and Weekly for 7 or 13 weeks
Sleep Self-Report 2
Single item measure of overall sleep quality on a scale of 1 to 5. A higher score indicates better sleep quality.
Daily for 7 or 13 weeks
Global Health
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.
Baseline and Weekly for 7 or 13 weeks
Measures of Activity: Step Count
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.
Daily for 7 or 13 weeks
Measures of Sleep: Sleep efficiency
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.
Daily for 7 or 13 weeks
Secondary Outcomes (3)
Active Step Count
Daily for 7 or 13 weeks
Number of Awakenings
Daily for 7 or 13 weeks
Total Sleep Time
Daily for 7 or 13 weeks
Study Arms (2)
Wait-List Control
NO INTERVENTIONFor 6 weeks, the Wait-List control group will continue collecting data by wearing their Fitbit and completing daily and weekly surveys sent by REDCap. They will then transition to the Experimental arm for Weeks 7 through 12.
App to guide self-acupressure
EXPERIMENTALThe intervention, App to guide Self-Acupressure, is delivered via a mobile health app which is used daily for 6 weeks to guide users to use self-acupressure. The dashboard provides options to tailor the rituals (stimulating and relaxing) 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 5 Point App, Inc.lead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
5 Point App Inc
New York, New York, 10011, United States
Related Publications (1)
Beck SL, Smith R, Mindes J, Beck K, Leah Kim J, Weitzman M, Stone JAM, Veleber S, Dudley WN. Feasibility and Usability of EnergyPoints: A Mobile Health App to Guide Acupressure Use for Cancer Symptom Management. Integr Cancer Ther. 2024 Jan-Dec;23:15347354231223965. doi: 10.1177/15347354231223965.
PMID: 38284345BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan L Beck, PhD
5 Point App, Inc.
- PRINCIPAL INVESTIGATOR
Melanie A Gold, DO
5 Point App, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- Study Participants (SPs) will know whether they are using the app or not and study staff must guide them in the onboarding process. The data collection process is independent of any research staff and occurs virtually using online surveys and trackers. The one exception is the exit interviews via Zoom. The Research Coordinator will be trained in proper interviewing techniques and the interview guide is designed to avoid leading questions. All SPs will receive the intervention and participate in an interview. The investigators will need to be aware of whether SPs are currently using the app to evaluate and report any adverse events. The statistical team will have no contact with SPs; group assignment will be revealed as part of analysis. Care providers may make referrals but will not be told of study assignment.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
January 1, 2025
Study Start
January 15, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The MPIs agree to make data available within one year of the completion of the funded project period and completed publication of manuscripts pertaining to the specific aims. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period. The MPIs agree to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations effective at the time of grant submission.
- Access Criteria
- All dataset(s) that can be shared will be available in Mendeley Data (a no cost repository).Mendeley Data provides searchable study-level metadata for dataset discovery. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. Once deposited in Mendeley Data, all data will be shared in a controlled fashion to assure compliance with the approved protocol and informed consent and privacy regulations. Institutions, groups, or researchers who propose to use the DCT data are required to submit a brief proposal/data request form describing the goals and methods of the proposed analyses. Based on this document and additional discussions with the party(ies) proposing the collaboration, the decision as to whether and/or how to proceed is made by consensus between the MPIs and the 5 Point App's CEO.
A. Types and amount of scientific data expected to be generated in the project: The decentralized clinical trial (DCT) will produce data from 180 cancer survivors with fatigue. There will both be quantitative and qualitative data including surveys, data synchronized from the Fitbit, and exit interview transcripts. All data will be deidentified. We will not share the software for the EnergyPoints app as it is proprietary and patented (application filed December 2023, patent pending).