EnergyPoints App for Fatigue in Cancer Survivors

Recruiting at 1 trial location

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

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the EnergyPoints App safe for use in humans?

The Untire app, which is similar to the EnergyPoints App, has been studied for cancer-related fatigue and is based on recommended behavioral and physical activity modifications. It has been launched in multiple countries, suggesting it is considered safe for use. ^{1 2 3 4 5}

How does the EnergyPoints App treatment for fatigue in cancer survivors differ from other treatments?

The EnergyPoints App is unique because it is a digital tool designed to help cancer survivors manage fatigue through self-management strategies, unlike traditional treatments that may involve face-to-face sessions or medications. This app offers a convenient, accessible way for users to engage in energy conservation and restoration techniques, potentially including relaxation and meditation, which are not typically part of standard care. ^{3 6 7 8 9}

What data supports the effectiveness of the EnergyPoints App treatment for fatigue in cancer survivors?

Research on similar apps, like the Untire app, shows that self-management programs delivered via mobile apps can help reduce fatigue in cancer survivors by focusing on mental processes, physical activity, and sleep. These findings suggest that the EnergyPoints App might also be effective in managing fatigue in this population. ^{1 3 4 7 10}

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. Canada pubmed.ncbi.nlm.nih.gov

Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A pilot study examining energy conservation for cancer treatment-related fatigue. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Untire: an all-embracing self-management eHealth program to cope with cancer-related fatigue. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Beating cancer-related fatigue with the Untire mobile app: Results from a waiting-list randomized controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial. [2022]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Managing post-therapy fatigue for cancer survivors using energy conservation training. [2009]

9. England pubmed.ncbi.nlm.nih.gov

Interventions for cancer-related fatigue: a scoping review. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Determinants of physical, affective, and cognitive fatigue during breast cancer therapy and 12 months follow-up. [2018]