Cancer-related Problem/ConditionNCT06754722
Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors
A study testing App to guide self-acupressure in people with Cancer-related Problem/Condition and Fatigue in Cancer Survivors, run by 5 Point App, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Fatigue in Cancer Survivors, Sleep Disturbances
- What is being tested?
- App to guide self-acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
5 Point App Inc
New York, New York, 10011
Ryan J Smith, MS, 917-327-0827, Ryan@5pointapp.com
Melanie A Gold, DO, 646-740-6525, melanie@5pointapp.com
About this study
Official title: Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors
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
Read the 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.
- Conditions
- Cancer-related Problem/Condition, Fatigue in Cancer Survivors, Sleep Disturbances, Health-related Quality of Life
- Being tested
- App to guide self-acupressure
- Keywords
- fatigue, sleep disturbances, acupressure, mobile health app, cancer survivors, cancer symptoms
- Medical subject headings
- Parasomnias, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App to guide self-acupressureOther
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 group | Role | What they receive |
|---|---|---|
| Wait-List Control | No 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. |
| App to guide self-acupressure | Experimental | 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 Receives: Other: App to guide self-acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily for 7 or 13 weeks
Secondary outcomes (3)
Active Step Count
Fitbit is worn 24/7 and data are synched via the EnergyPoints app. Active minutes are calculated based on achieving a certain level of activity (with an algorithm). The measure in number of active minutes per 24 hours. The range is 0 to individual's maximum.
Measured: Daily for 7 or 13 weeks
Number of Awakenings
The Fitbit is worn 24/7 to measure activity and sleep. The number of awakenings is the number of times the participants wakes up from sleep during a 24 hour period.
Measured: Daily for 7 or 13 weeks
Total Sleep Time
The Fitbit is worn 24/7 to measure activity and sleep. Total sleep time is the total number of minutes that the participant sleeps in 24 hours.
Measured: Daily for 7 or 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 5 Point App, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan L Beck, PhD, Principal investigator, 5 Point App, Inc.Melanie A Gold, DO, Principal investigator, 5 Point App, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754722
- Sponsor's protocol ID
- R44CA297977-01
- Other IDs
- R44CA297977-01
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 38284345
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors
- ClinicalTrials.gov ID
- NCT06754722
- Acronym / sponsor ID
- R44CA297977-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- 5 Point App, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wait-List Control | No 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. |
| App to guide self-acupressure | Experimental | Other: App to guide self-acupressureThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App to guide self-acupressureThe 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. | Other | App to guide self-acupressure |
Primary outcome
Fatigue self-report 1
Time frame: Baseline and Weekly for 7 or 13 weeks
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.
Fatigue self-report 2
Time frame: Daily for 7 or 13 weeks
Patient Reported Outcome Measurement Information System (PROMIS) single item of fatigue intensity on a 1 to 5 scale. A higher score indicates more fatigue.
Sleep Self-Report 1
Time frame: Baseline and Weekly for 7 or 13 weeks
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.
Sleep Self-Report 2
Time frame: Daily for 7 or 13 weeks
Single item measure of overall sleep quality on a scale of 1 to 5. A higher score indicates better sleep quality.
Global Health
Time frame: Baseline and Weekly for 7 or 13 weeks
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.
Measures of Activity: Step Count
Time frame: Daily for 7 or 13 weeks
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.
Measures of Sleep: Sleep efficiency
Time frame: Daily for 7 or 13 weeks
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.
3 secondary outcomes
Active Step Count
Time frame: Daily for 7 or 13 weeks
Number of Awakenings
Time frame: Daily for 7 or 13 weeks
Total Sleep Time
Time frame: Daily for 7 or 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 38284345Beck 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan L Beck, PhD principal investigator
5 Point App, Inc.
Melanie A Gold, DO principal investigator
5 Point App, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App to guide self-acupressure in people with Cancer-related Problem/Condition and Fatigue in Cancer Survivors, run by 5 Point App, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan L Beck, PhD (801-971-5338, susie@5pointapp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue self-report 1 (time frame: Baseline and Weekly for 7 or 13 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.