OncologySTEPPNCT03952767
The STEPP Study: Sensors To Evaluate Physical Performance
A study testing Digital Physical Measures and Survey Assessments in people with Oncology, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Oncology
- What is being tested?
- Digital Physical Measures and Survey Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 30 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All genders aged ≥ 18 years of age
- Patients being seen at UNCCH for treatment of cancer.
- English-speakers
- Able to understand and cooperate with study procedures.
- Patients with solid tumors or hematological malignancies, and self-reported KPS ≤70 to ≥ 100.
- Signed and dated informed consent and HIPPA.
Who cannot join
- Subjects using investigational/experimental products.
- Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.
- Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days.
- Unable to speak English.
- Subjects who report any other medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent.
- Subjects who are allergic to silicone or adhesives. Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).
Read the detailed description
This study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. The study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. The participants will also be asked to fill out survey data regarding their health. At-home data will be collected for 14 days. During this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data.
Primary Objective:
- Assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. KPS)
- Conditions
- Oncology
- Being tested
- Digital Physical Measures and Survey Assessments
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Physical Measures and Survey AssessmentsOther
Data from at home and in clinic visits will assess physical function and survey data will be collected
| Study group | Role | What they receive |
|---|---|---|
| Digital Physical Measures and Survey Assessments | Experimental | Digital physical measure data will be collected in clinic and at home and survey assessments will be collected Receives: Other: Digital Physical Measures and Survey Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of mean steps per day recorded at home
At-home record of mean steps per day
Measured: 18 months
Amount of mean sedentary activity time recorded at home
At-home record of minutes per day of mean sedentary activity time
Measured: 18 months
Amount of Light activity time recorded at home
At-home record of minutes per day of light activity time per day
Measured: 18 months
Amount of moderate activity time recorded at home
At-home record of minutes per day of moderate activity time
Measured: 18 months
Amount of vigorous activity time recorded at home
At-home record of minutes per day of vigorous activity time
Measured: 18 months
Self-Reported Karnofsky Performance Score (KPS)
The validated 1 question Self-reported Karnofsky Performance Score (KPS) score 0 to 100 will be measured. Scores closer to 100 indicate high performance of the patient
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start24 Apr 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2022
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 OncologyStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952767
- Sponsor's protocol ID
- LCCC 1851
- Acronym
- STEPP
- Status last verified
- Oct 2022
- First submitted
- 13 May 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karahanoglu FI, Jensen CE, Cai X, Santamaria M, Psaltos D, Messere A, Demanuele C, Stone J, Tarachandani A, Adamowicz L, Muss H, Wood WA. Improved functional assessment in cancer patients using home-based digital technologies. Sci Rep. 2025 May 21;15(1):17638. doi: 10.1038/s41598-025-02401-4.
PubMed 40399391
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STEPP Study: Sensors To Evaluate Physical Performance
- ClinicalTrials.gov ID
- NCT03952767
- Acronym / sponsor ID
- STEPP / LCCC 1851
- Conditions
- Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 16 May 2019 (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 study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).
Detailed description
This study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. The study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. The participants will also be asked to fill out survey data regarding their health. At-home data will be collected for 14 days. During this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data.
Primary Objective:
- Assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. KPS)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Physical Measures and Survey Assessments | Experimental | Other: Digital Physical Measures and Survey AssessmentsDigital physical measure data will be collected in clinic and at home and survey assessments will be collected |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All genders aged ≥ 18 years of age
- Patients being seen at UNCCH for treatment of cancer.
- English-speakers
- Able to understand and cooperate with study procedures.
- Patients with solid tumors or hematological malignancies, and self-reported KPS ≤70 to ≥ 100.
Key exclusion criteria (6 listed)
- Subjects using investigational/experimental products.
- Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.
- Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days.
- Unable to speak English.
- Subjects who report any other medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent.
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 |
|---|---|---|
| Digital Physical Measures and Survey AssessmentsData from at home and in clinic visits will assess physical function and survey data will be collected | Other | Digital Physical Measures and Survey Assessments |
Primary outcome
Amount of mean steps per day recorded at home
Time frame: 18 months
At-home record of mean steps per day
Amount of mean sedentary activity time recorded at home
Time frame: 18 months
At-home record of minutes per day of mean sedentary activity time
Amount of Light activity time recorded at home
Time frame: 18 months
At-home record of minutes per day of light activity time per day
Amount of moderate activity time recorded at home
Time frame: 18 months
At-home record of minutes per day of moderate activity time
Amount of vigorous activity time recorded at home
Time frame: 18 months
At-home record of minutes per day of vigorous activity time
Self-Reported Karnofsky Performance Score (KPS)
Time frame: 18 months
The validated 1 question Self-reported Karnofsky Performance Score (KPS) score 0 to 100 will be measured. Scores closer to 100 indicate high performance of the patient
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 25 Oct 2022.
- Derived from this study: PubMed 40399391Karahanoglu FI, Jensen CE, Cai X, Santamaria M, Psaltos D, Messere A, Demanuele C, Stone J, Tarachandani A, Adamowicz L, Muss H, Wood WA. Improved functional assessment in cancer patients using home-based digital technologies. Sci Rep. 2025 May 21;15(1):17638. doi: 10.1038/s41598-025-02401-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Physical Measures and Survey Assessments in people with Oncology, run by UNC Lineberger Comprehensive Cancer Center 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 6 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 25 Oct 2022. 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?
Amount of mean steps per day recorded at home (time frame: 18 months). The study lists 6 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 NCT03952767, 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 25 Oct 2022.