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

NCT06668402 | Active Not Recruiting

• 1 other identifier: AESH-BADEK-2024-725
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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)

Outcome Measures

Primary Outcomes (1)

• The rate of pathological complete response in rectal cancer patients receiving neoadjuvant therapy

  This outcome measure assesses the relationship between daily physical activity levels, specifically step count, and the rate of pathological complete response (pCR) in rectal cancer patients undergoing neoadjuvant therapy. By tracking patients' step counts throughout the treatment period, we aim to investigate whether higher physical activity levels correlate with a higher likelihood of achieving a pCR, defined as no residual tumor in resected tissue at the time of surgery.

  9 months

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve adult patients diagnosed with locally advanced rectal cancer (stages II and III) who are scheduled to receive total neoadjuvant therapy (TNT), which includes chemotherapy and radiotherapy prior to surgery. Participants are required to have sufficient physical capacity for regular activity monitoring via a wearable smartwatch, which will collect data on physical activity, heart rate, and sleep quality. Stage I and metastatic (stage IV) rectal cancer patients are excluded, as they are not candidates for TNT. The study population represents individuals who are eligible for this preoperative treatment and can benefit from objective monitoring of activity as part of their treatment response assessment.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Prior treatment for rectal cancer with chemotherapy or radiotherapy.
• Use of a pacemaker or other implanted medical devices that might interfere with smartwatch functionality.
• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Gazi University

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ozan Yazici, Prof. Dr.

  Gazi University

  STUDY CHAIR

• Osman Sutcuoglu, Associate Professor

  Gazi University

  STUDY DIRECTOR

• Orhun Akdogan, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: October 30, 2024
• Primary Completion: December 15, 2025
• Study Completion: March 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)