Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors

Part of paid clinical trials in New York, New York.

Sponsor
5 Point App, Inc.
Study ID
NCT06754722
Status
Recruiting
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Conditions

  • Cancer-related Problem/Condition
  • Fatigue in Cancer Survivors
  • Health-related Quality of Life
  • Sleep Disturbances

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • App to guide self-acupressure — OTHER
    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 Details

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

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Wait-List Control
    For 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.
  • Experimental: App to guide self-acupressure
    The 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

Primary Outcome Measure

Fatigue self-report 1 [ Time Frame: Baseline and Weekly for 7 or 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
5 Point App IncNew YorkNew York10011
Ryan J Smith, MS
[email protected]
917-327-0827
Melanie A Gold, DO
[email protected]
646-740-6525
Susan L Beck, PhD (PRINCIPAL_INVESTIGATOR)
Melanie A Gold, DO (PRINCIPAL_INVESTIGATOR)

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