NCT06668402Completed
Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R)
Prospective Observational Study of the Association Between Daily Step Count and Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy: STEP-R Trial
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Using Huawei Watch Fit 2 smartwatches, we will track participants' daily step counts, heart rate, and sleep quality. The primary hypothesis is that higher step counts and physical activity levels correlate with higher rates of complete pathological response at surgery. A secondary hypothesis is that increased physical activity may be associated with fewer or less severe side effects during treatment. Participants will wear a smartwatch and complete the EORTC QLQ-C30 Quality of Life Questionnaire and the Pittsburgh Sleep Quality Index at the beginning and end of treatment. Data from the smartwatch, including step count, heart rate changes, and sleep duration, will be reviewed weekly during routine visits. Approximately 200 patients with rectal cancer will participate, and each will be followed from the start of therapy until surgery (around 4-6 months). Total data collection is expected to take 12-15 months. This study could improve cancer care by identifying links between physical activity and treatment outcomes, supporting future exercise guidelines for oncology patients.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 160 (actual)
- First submitted
- 30 Oct 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 15 May 2026
- Lead sponsor
- Gazi University
- Diseases
- Colorectal cancer
- NCT number
- NCT06668402
What you commit to
- Study type: Observational
- Participants enrolled: 160
- From 30 Oct 2024 to the primary completion date, 15 May 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for rectal cancer with chemotherapy or radiotherapy.
Other illness
- Stage I or metastatic (stage IV) rectal cancer.
- Contraindications to physical activity, including but not limited to severe cardiovascular or respiratory conditions that limit mobility.
- Known allergic reaction to materials in the Huawei Watch Fit 2 smartwatch.
- Severe cognitive or psychological disorders that would hinder participation in the study or completion of questionnaires.
- Any medical or psychiatric condition that, in the opinion of the investigator, may compromise patient safety or interfere with study adherence.
Other
- Use of a pacemaker or other implanted medical devices that might interfere with smartwatch functionality.
Who the study is looking for
- Patients aged 18 years and older.
- Diagnosed with locally advanced rectal cancer (stage II or III) and eligible for total neoadjuvant therapy (TNT).
- Planned to undergo chemotherapy and radiotherapy as part of neoadjuvant treatment before surgery.
- Capable of providing informed consent.
- Able to wear and operate the Huawei Watch Fit 2 smartwatch throughout the treatment period.
- Sufficient mobility to engage in physical activity, including walking, as per study requirements.
- Willing to complete weekly monitoring visits and complete the EORTC QLQ-C30 and Pittsburgh Sleep Quality Index questionnaires at baseline and study end
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Etlik City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.