FatigueNCT04983342
Apollo Device for Metastatic Breast Cancer (MBC)
A study testing Apollo Armband in people with Fatigue and Metastatic Breast Carcinoma, run by Margaret Quinn Rosenzweig at 1 site in United States.
Trial summary
This is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called Apollo, which is similar to a FitBit but emits vibrations. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Fatigue, Metastatic Breast Carcinoma
- What is being tested?
- Apollo Armband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic breast cancer diagnosis
- Fatigue score of 4 or greater at last clinic visit
Who cannot join
- Not able to read and understand English
- Use of Beta Blockers,
- Use of medications for serious mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Apollo Device for Fatigue in Metastatic Breast Cancer
This is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called Apollo, which is similar to a FitBit but emits vibrations. Our primary objective is to assess whether or not Apollo can help with symptoms of fatigue and pain in patients with Metastatic Breast Cancer (MBC).
Read the detailed description
This study aims to provide preliminary data on the efficacy and tolerability of the Apollo device in the management of fatigue and pain in patients with Metastatic Breast Cancer (MBC).
Apollo is about the size of an Apple Watchand can be worn on the ankle, wrist, or armwith two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears. The scientific principles guiding the use of Apollo and mechanistic understanding of its effects on the body are consistent with the understanding of how music and therapeutic touch effect the body to convey feelings of energy, focus, or relaxation by sending safety signals to the emotional cortex (limbic system) in the brain. Similar to music and touch used to facilitate a healing response in the body, there are no known side effects to this type of therapy.
The PROMIS-Fatigue scale and the Functional Assessment of Cancer Therapy Fatigue (FACT-F) are instruments that have been previously validated in multiple diseases and will be used in this study. Preliminary data on indices of pain, use of PRN pain medications, health-related quality of life, sleep, anxiety and depression and tolerability/frequency of use with the Apollo device in MBC will also be evaluated using:
- PROMIS pain scale
- Use of pain medications
- Health-related quality of life (HRQOL) using PROMIS-29
- PROMIS Sleep
- Hospital Anxiety and Depression Scale (HADS)
- Usage data from Apollo app
This study aims to identify improvement of fatigue symptoms from baseline after 4 and 8 weeks of Apollo use. Improvements in pain, quality of life, use of PRN pain medication, anxiety and sleep.
- Conditions
- Fatigue, Metastatic Breast Carcinoma
- Being tested
- Apollo Armband
- Medical subject headings
- Fatigue, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo ArmbandDevice
The Apollo armband is approximately the size of an Apple Watch and can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears.
| Study group | Role | What they receive |
|---|---|---|
| Apollo Armband | Experimental | Armband that can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. Receives: Device: Apollo Armband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue (PROMIS-Fatigue)
Change from baseline to 4 and then 8 weeks as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue scale, which measures the presence of fatigue and its interference with life. PROMIS-Fatigue includes 6 items with scores 1-5 for each item, total scores 6-30. Lower scores indicate less fatigue and interference from fatigue.
Measured: Up to 8 weeks
Change in Fatigue (FACT-F)
Change from baseline to 4 and then 8 weeks as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item, 5 choice/item measure ranging from 0 (Not at all) to 4 (Very much) that assesses self-reported fatigue and its impact upon daily activities and function, 0-160 is the total score with higher scores indicating better QOL, the lower the fatigue symptoms. The recall period refers to the "past 7 days".
Measured: Up to 8 weeks
Secondary outcomes (5)
Degree of Pain
The PROMIS Pain scale will be used to measure the degree of pain experienced. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Intensity part is a 3-item scale focuses on representing the full range of possible pain intensity using psychometric properties and clinical input, with frequency (never to always) and severity (none to very severe) Likert-type response scales. The final measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5. Scores range from 3-15, with higher scores indicating more severe pain. The pain interference part consists of 6 items ranging 1 through 5 - total scores 6-30. Higher scores indicate higher degrees of interference with important aspects of life. The recall period for all pain quality items is the past 7 days.
Measured: Up to 8 weeks
Use of pain medications
The dosage of specific medications will be recorded.
Measured: Up to 8 weeks
Health Related quality of life (HRQOL)
Quality of Life will be assessed using the the Promis-29. The Promis-29 is a short form assessment containing four items from each of seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities) plus one pain intensity question (0-5 numeric rating scale). Higher scores indicate greater difficulty and/or poorer quality of life.
Measured: Up to 8 weeks
Promis Sleep Measurement
Measure of sleep difficulty by first asking the participant to rate their sleep quality (very poor, poor, fair, good, very good). Participants are then ask to rate their sleep as, "refreshing; had a problem with sleep; had difficulty falling asleep; sleep was restless, hard to get to sleep, worried about not being able to get to sleep, unsatisfied with their sleep. Response scale: Not at all, A little bit, Somewhat, Quite a bit, Very much. Scoring scale is 1-5 (Very poor ,poor, fair, good, very good) Total scores range from 8-45, with higher numbers indicating better sleep.
Measured: Up to 8 weeks
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) assesses both anxiety and depression, focusing on non-physical symptoms so that it can be used to diagnose depression in people with significant physical ill-health. Self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The HADS questionnaire takes 2-5 min to complete and is comprised of seven questions for anxiety and seven questions for depression, with anxiety and depression questions interspersed within.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Feb 2021
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot design -pre and post
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margaret Quinn Rosenzweig
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Neuroscience, Inc.
- Responsible party
- Sponsor-investigator, Margaret Quinn Rosenzweig, University of Pittsburgh
- Investigators
- Margaret Q Rosenzweig, Principal investigator, University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983342
- Sponsor's protocol ID
- HCC 20-243
- Status last verified
- Jun 2024
- First submitted
- 15 Jul 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If investigators want to see de-identified data we will work with Apollo company to share data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apollo Device for Fatigue in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04983342
- Acronym / sponsor ID
- HCC 20-243
- Conditions
- Fatigue, Metastatic Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Margaret Quinn RosenzweigUniversity, hospital or other
- Collaborators
- Apollo Neuroscience, Inc.
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 30 Jul 2021 (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.
This is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called Apollo, which is similar to a FitBit but emits vibrations. Our primary objective is to assess whether or not Apollo can help with symptoms of fatigue and pain in patients with Metastatic Breast Cancer (MBC).
Detailed description
This study aims to provide preliminary data on the efficacy and tolerability of the Apollo device in the management of fatigue and pain in patients with Metastatic Breast Cancer (MBC).
Apollo is about the size of an Apple Watchand can be worn on the ankle, wrist, or armwith two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears. The scientific principles guiding the use of Apollo and mechanistic understanding of its effects on the body are consistent with the understanding of how music and therapeutic touch effect the body to convey feelings of energy, focus, or relaxation by sending safety signals to the emotional cortex (limbic system) in the brain. Similar to music and touch used to facilitate a healing response in the body, there are no known side effects to this type of therapy.
The PROMIS-Fatigue scale and the Functional Assessment of Cancer Therapy Fatigue (FACT-F) are instruments that have been previously validated in multiple diseases and will be used in this study. Preliminary data on indices of pain, use of PRN pain medications, health-related quality of life, sleep, anxiety and depression and tolerability/frequency of use with the Apollo device in MBC will also be evaluated using:
- PROMIS pain scale
- Use of pain medications
- Health-related quality of life (HRQOL) using PROMIS-29
- PROMIS Sleep
- Hospital Anxiety and Depression Scale (HADS)
- Usage data from Apollo app
This study aims to identify improvement of fatigue symptoms from baseline after 4 and 8 weeks of Apollo use. Improvements in pain, quality of life, use of PRN pain medication, anxiety and sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot design -pre and post
| Arm | Type | Receives |
|---|---|---|
| Apollo Armband | Experimental | Device: Apollo ArmbandArmband that can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metastatic breast cancer diagnosis
- Fatigue score of 4 or greater at last clinic visit
Key exclusion criteria (3 listed)
- Not able to read and understand English
- Use of Beta Blockers,
- Use of medications for serious mental illness
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 |
|---|---|---|
| Apollo ArmbandThe Apollo armband is approximately the size of an Apple Watch and can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears. | Device | Apollo Armband |
Primary outcome
Change in Fatigue (PROMIS-Fatigue)
Time frame: Up to 8 weeks
Change from baseline to 4 and then 8 weeks as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue scale, which measures the presence of fatigue and its interference with life. PROMIS-Fatigue includes 6 items with scores 1-5 for each item, total scores 6-30. Lower scores indicate less fatigue and interference from fatigue.
Change in Fatigue (FACT-F)
Time frame: Up to 8 weeks
Change from baseline to 4 and then 8 weeks as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item, 5 choice/item measure ranging from 0 (Not at all) to 4 (Very much) that assesses self-reported fatigue and its impact upon daily activities and function, 0-160 is the total score with higher scores indicating better QOL, the lower the fatigue symptoms. The recall period refers to the "past 7 days".
5 secondary outcomes
Degree of Pain
Time frame: Up to 8 weeks
Use of pain medications
Time frame: Up to 8 weeks
Health Related quality of life (HRQOL)
Time frame: Up to 8 weeks
Promis Sleep Measurement
Time frame: Up to 8 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. If investigators want to see de-identified data we will work with Apollo company to share data.
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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. This study is not recruiting at the moment.
Margaret Q Rosenzweig principal investigator
University of Pittsburgh School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Armband in people with Fatigue and Metastatic Breast Carcinoma, run by Margaret Quinn Rosenzweig 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 2 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: finished, as of the sponsor's last update on 21 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue (PROMIS-Fatigue) (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.