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Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R)

NCT06668402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Exercise
  • Total Neoadjuvant Treatment
  • Rectal Tumors
  • Smart Watch
  • Quality of Life (QOL)

Interventions

DEVICE

Utilizing a smartwatch to gather data on individuals receiving treatment for rectal neoplasm.

Employing a smartwatch to monitor steps, sleep quality, intense physical activity, and vital signs in persons undergoing treatment for rectal carcinoma.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Ozan Yazici, Prof. Dr. · Gazi University

  • Osman Sutcuoglu, Associate Professor · Gazi University

  • Orhun Akdogan, MD · Gazi University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2025-12-15
Completion
2026-03-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668402 on ClinicalTrials.gov