EnergyPoints App for Fatigue in Cancer Survivors

Not yet recruiting at 2 trial locations

Overseen By Susan L Beck, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 5 Point App, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Easy bruising, EnergyPoints app, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the EnergyPoints app, which instructs users in self-acupressure (applying pressure to specific body points) to help reduce fatigue and improve sleep in cancer survivors. Participants will use the app daily while wearing a Fitbit and will be randomly assigned to one of two groups—one starts the app immediately, and the other waits six weeks before starting. The trial seeks cancer survivors who feel very tired (fatigued) and have a smartphone. As an unphased trial, this study offers participants a unique opportunity to explore innovative ways to manage fatigue and improve sleep.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you cannot participate in the study.

What prior data suggests that the EnergyPoints App is safe for cancer survivors?

Research has shown that using the EnergyPoints app for self-acupressure is generally safe. Previous studies found only minor risks. Some users might notice slight bruising or soreness at pressure points, which are the main reported side effects. Additionally, as with any mobile app, there is a small chance that personal information could be accessed by unauthorized individuals. Overall, the app is designed to safely help manage fatigue and sleep issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for fatigue in cancer survivors, which often involve medications or therapies like cognitive behavioral therapy, the EnergyPoints App offers a novel approach by delivering self-acupressure guidance through a mobile app. This app is unique because it allows users to customize their acupressure routines with options for stimulating or relaxing rituals and adjust pressing times to fit their symptoms and lifestyle. Additionally, the app integrates enhancements like aromatherapy, relaxing music, and visuals, providing a holistic experience. Researchers are excited about this trial because it leverages technology to offer a flexible, personalized treatment option that empowers users to manage their fatigue more effectively.

What evidence suggests that the EnergyPoints App is effective for reducing fatigue in cancer survivors?

Research has shown that acupressure effectively reduces tiredness and improves sleep. Studies found a strong impact on reducing tiredness and a significant improvement in sleep. In this trial, participants in the experimental arm will use the EnergyPoints app, designed to guide users in applying acupressure to manage these issues. Although the app is new, the acupressure method it employs has shown promise in helping people with cancer manage tiredness and sleep problems. ^{1 2 5 6 7}

Who Is on the Research Team?

Susan L Beck, PhD

Principal Investigator

5 Point App, Inc.

Melanie A Gold, DO

Principal Investigator

5 Point App, Inc.

Are You a Good Fit for This Trial?

This trial is for cancer survivors experiencing fatigue and sleep issues. Participants must be comfortable using a mobile app and wearing a fitness tracker daily. They should be willing to complete questionnaires and an online interview. There are no specific exclusion criteria provided.

Inclusion Criteria

Able to read and speak in English

Have a smartphone (iPhone 8 or later or Android 11 or later)

I have cancer or have been treated for cancer.

Exclusion Criteria

I am taking blood thinners.

Previous use of the EnergyPoints app

I have been bruising or bleeding easily lately.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Remote participation

Baseline

Participants get used to wearing the Fitbit and establish baseline measurements

1 week

Remote participation

Treatment (Immediate Group)

Participants in the Immediate Group use the EnergyPoints app for self-acupressure for 6 weeks

6 weeks

Remote participation with daily app usage

Wait-List Control

Participants in the Wait-List Group wear the Fitbit and complete surveys for 6 weeks before starting treatment

6 weeks

Remote participation with daily surveys

Treatment (Wait-List Group)

Participants in the Wait-List Group use the EnergyPoints app for self-acupressure for 6 weeks after the initial wait period

6 weeks

Remote participation with daily app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Remote participation with exit interview and questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• EnergyPoints App

Trial Overview The study tests the EnergyPoints app, which guides users in self-acupressure to see if it can reduce fatigue and improve sleep quality. It's a remote trial with two groups: one starts using the app immediately, while the other waits six weeks before starting.

How Is the Trial Designed?

Group I: App to guide self-acupressure Experimental Treatment 1 Intervention

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

Group II: Wait-List Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

5 Point App, Inc.

Lead Sponsor

Trials

1

Recruited

180+

Published Research Related to This Trial

The Untire mHealth app significantly improved fatigue severity and quality of life in cancer patients and survivors, with 519 participants in the intervention group showing better outcomes compared to 280 in the control group over 12 weeks.

Participants who used the app more frequently experienced the greatest benefits, indicating that higher engagement with the app correlates with improved management of cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beating cancer-related fatigue with the Untire mobile app: Results from a waiting-list randomized controlled trial. Spahrkäs, SS., Looijmans, A., Sanderman, R., et al.[2021]

A 12-week remote Fatigue Reduction Diet (FRD) intervention for diffuse large B-cell lymphoma (DLBCL) survivors was feasible and well-accepted, with 90% of participants attending all sessions.

Participants showed significant improvements in diet quality and a reduction in cancer-related fatigue, indicating that dietary interventions may be effective in enhancing the quality of life for lymphoma survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote Whole Food Dietary Intervention to Reduce Fatigue and Improve Diet Quality in Lymphoma Survivors: Results of a Feasibility Pilot Study. Weinhold, KR., Light, S., Bittoni, AM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06754722

Study Details | NCT06754722 | Decentralized Clinical Trial ... Evidence supports the efficacy of acupressure to reduce fatigue (Effect size = 0.87) and improve sleep [Mean Difference (MD)= 3.72]14-19, but it is currently ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10826379/

Feasibility and Usability of EnergyPoints: A Mobile Health App ... An innovative mobile health app that teaches and guides people with cancer to implement daily acupressure to self-manage their fatigue and sleep disturbances.

3. reporter.nih.gov reporter.nih.gov/project-details/10255903

Project Details - NIH RePORTER The EnergyPoints App will motivate and guide cancer patients to implement daily acupressure protocols to self-manage fatigue and sleep disturbances. The app ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15347354231223965

A Mobile Health App to Guide Acupressure Use for Cancer ... An innovative mobile health app that teaches and guides people with cancer to implement daily acupressure to self-manage their fatigue and sleep disturbances.

5. researchgate.net researchgate.net/publication/377774660_Feasibility_and_Usability_of_EnergyPoints_A_Mobile_Health_App_to_Guide_Acupressure_Use_for_Cancer_Symptom_Management

Feasibility and Usability of EnergyPoints: A Mobile Health ... Objective To examine the feasibility and usability of EnergyPoints™, an innovative mobile health app that teaches and guides people with cancer to implement ...

6. energypointsapp.com energypointsapp.com/app/

App - EnergyPoints For Healthcare Providers. EnergyPoints App helps people with cancer learn safe and effective self-care techniques without the need for professional training.

7. withpower.com withpower.com/trial/energypoints-app-for-fatigue-in-cancer-survivors-14107

EnergyPoints App for Fatigue in Cancer Survivors * 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 ...