Clinical trial NCT06754722: Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors
Official title: Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer-related Problem/condition
Fatigue in Cancer Survivors
Sleep Disturbances
Health-related Quality of Life
Keywords: fatigue
sleep disturbances
acupressure
mobile health app
cancer survivors
cancer symptoms
Lead sponsor: 5 Point App, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a parallel group (between subjects) trial with a one-week baseline to orient Study Participants (SPs) to the Fitbit. We will randomize SPs to either the Intervention (Immediate Group) (n=90) or Wait-List Control Group (n=90) . The Immediate Group will receive the EnergyPoints app after the baseline period (Week 0) and perform self-acupressure daily at home for the next 6 weeks (Weeks 1-6), at which point the intervention is complete. The Wait-List Control Group will provide data only for Weeks 1 to 6 then transition to the intervention during Weeks 7-12.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study from 5 Point App, Inc. aims to further test EnergyPoints-an app to help cancer survivors (people living with cancer both on and off treatment) administer acupressure to self-manage cancer-related fatigue (CRF) and sleep deficiency. The study aims to validate the effectiveness of the app on clinical outcomes in a decentralized clinical trial (DCT). The expert interdisciplinary team consists of scientists and clinical experts in acupressure, symptom management, and informatics; qualitative and quantitative analysts; software engineers and marketing experts.

Up to 90% of patients receiving cancer treatment experience CRF; 30% may experience long-lasting fatigue. Sleep deficiency affects up to 75% of survivors, contributes to poor health and may exacerbate fatigue. These symptoms impact the physical, emotional, and social health of millions of cancer survivors. Exercise is most recommended for CRF, yet exercise may be difficult for some. Evidence supports benefits of other non-pharmacologic therapies (e.g., cognitive behavioral therapy-insomnia and mindfulness) for CRF and sleep disturbances, but these therapies may be unavailable, costly, or not widely adopted. 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 unfamiliar to many cancer survivors. Acupressure requires instruction by a skilled practitioner and is not covered by insurance; EnergyPoints addresses these critical barriers to adoption.

EnergyPoints app, on iOS and Android, educates and guides use of acupressure rituals to self-manage fatigue and sleep disturbances1. 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. Regardless of location or access to a qualified instructor, users can self-treat and monitor symptoms and share a pdf of progress with their health care providers. The long-term goal is to improve clinical outcomes for cancer survivors by mainstreaming acupressure as a safe, affordable, self-care technique for managing symptoms. Once widely adopted, real-world-data from the app will advance science, allowing assessment of varying doses, types, and durations on effectiveness of acupressure.

During systematic user testing of EnergyPoints, cancer survivors performed acupressure as directed. Participants correctly located points and found the app easy to use; we established feasibility of connecting fitness tracker data. We added features identified by participants, such as music during the acupressure session. Participants completed at least one ritual (3 minutes per point) 87% of the time and both rituals 68% of the time. Some participants asked for "an express version." As there is no established standard for type of ritual or minimal dose of acupressure, the investigators developed a more scalable approach, allowing users to personalize their acupressure rituals to improve the experience and outcome. Users can choose rituals and timing for ½, 1, or 2 minutes per point.

The investigators will conduct a DCT in which 180 adult cancer survivors with CRF will test the EnergyPoints app at home for 6 weeks. Blocking on treatment status (on and off cancer treatment), the investigators will randomize a national, geographically, racially, and ethnically diverse sample of 180 adult cancer survivors with CRF to the EnergyPoints App-Immediate Group or a Wait-List Control Group. Data includes weekly self-report and daily app and fitness tracker measures of fatigue, sleep, and quality of life (physical and mental health). An exit interview and questionnaire will assess usability, acceptance, and desirability.

Specific Aim 1: Determine the effectiveness of EnergyPoints on clinical outcomes. The investigators will first identify key time points \[baseline, start of benefit, peak of benefit\] in trajectories of six weekly outcomes: fatigue, sleep, physical and mental health, total steps, and sleep efficiency. The primary analysis will then test effectiveness (Baseline to Start and Baseline to Peak, controlling for age, gender, and treatment status) by examining between- and within-subjects effects with linear mixed models in an intent-to-treat approach. The investigators will also explore the moderating effect of other personal factors and co-occurring symptoms. Milestone: Use of the app (vs. control) will clinically (MD=0.5 SD) and statistically (Group by Time interaction, p\<.001) improve outcomes.

Specific Aim 2: Identify important intervention dose and enhancement effects to guide ongoing app modifications. Combining intervention data from both groups, the investigators will estimate dose and enhancement effects by analyzing interaction of time (Baseline to Peak) with intervention dose and enhancement features (e.g., dose of each ritual, time of pressing points, ritual adherence, and use of music). Milestone Significant (p\<.001) interaction effects will elucidate important intervention features; effect sizes will estimate the impact.

Eligibility criteria: Inclusion Criteria:

* Have cancer or have been treated for cancer;
* at least a moderate level of fatigue (greater than 4on a 0 to 10 Likert-type scale);
* able to read and speak in English;
* age 18 years or older;
* have a smartphone (iPhone 8 or later orAndroid 11 or later),
* adequate hearing, vision, and functional ability to see, hear and use the app and participate in interviews,
* willing to wear a Fitbit 24/7 (except when charging) throughout the study.

Exclusion Criteria:

* recent history of easy bruising or bleeding
* receiving anticoagulants (e.g., warfarin, rivaroxaban)
* 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.

Primary outcomes:
measure: Fatigue self-report 1
timeFrame: Baseline and Weekly for 7 or 13 weeks
measure: Fatigue self-report 2
timeFrame: Daily for 7 or 13 weeks
measure: Sleep Self-Report 1
timeFrame: Baseline and Weekly for 7 or 13 weeks
measure: Sleep Self-Report 2
timeFrame: Daily for 7 or 13 weeks
measure: Global Health
timeFrame: Baseline and Weekly for 7 or 13 weeks
measure: Measures of Activity: Step Count
timeFrame: Daily for 7 or 13 weeks
measure: Measures of Sleep: Sleep efficiency
timeFrame: Daily for 7 or 13 weeks
Secondary outcomes:
measure: Active Step Count
timeFrame: Daily for 7 or 13 weeks
measure: Number of Awakenings
timeFrame: Daily for 7 or 13 weeks
measure: Total Sleep Time
timeFrame: Daily for 7 or 13 weeks
Other outcomes:
Locations:
city: New York City
country: United States
facility: 5 Point App Inc
state: New York
city: Salt Lake City
country: United States
facility: University of Utah College of Nursing
state: Utah
Study officials:
affiliation: 5 Point App, Inc.
name: Susan L Beck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 5 Point App, Inc.
name: Melanie A Gold, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.