Clinical trial · Interventional
The STEPP Study: Sensors To Evaluate Physical Performance
NCT03952767CI-TRIAL-00061658STEPPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Physical Measures and Survey Assessments | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Digital Physical Measures and Survey Assessments
- description
- Digital physical measure data will be collected in clinic and at home and survey assessments will be collected
- interventionNames
- Other: Digital Physical Measures and Survey Assessments
Primary outcomes (6)
- measure
- Amount of mean steps per day recorded at home
- timeFrame
- 18 months
- description
- At-home record of mean steps per day
- measure
- Amount of mean sedentary activity time recorded at home
- timeFrame
- 18 months
- description
- At-home record of minutes per day of mean sedentary activity time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. All genders aged ≥ 18 years of age 2. Patients being seen at UNCCH for treatment of cancer. 3. English-speakers 4. Able to understand and cooperate with study procedures. 5. Patients with solid tumors or hematological malignancies, and self-reported KPS ≤70 to ≥ 100. Signed and dated informed consent and HIPPA. Exclusion Criteria: 1. Subjects using investigational/experimental products. 2. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent. 3. Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days. 4. Unable to speak English. 5. 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. 6. Subjects who are allergic to silicone or adhesives. Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.
References
Publications (1)
- DERIVEDKarahanoglu 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. PMID 40399391