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

Launched by GAZI UNIVERSITY · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how daily physical activity, measured by the number of steps taken, affects treatment outcomes in patients with locally advanced rectal cancer. The goal is to see if being more active during total neoadjuvant therapy, which includes chemotherapy and radiotherapy before surgery, can lead to better results and fewer side effects. Participants will wear a Huawei Watch Fit 2 smartwatch to track their daily steps, heart rate, and sleep quality throughout their treatment, while also filling out questionnaires about their quality of life and sleep at the beginning and end of the study.

To be eligible for the study, participants should be 18 years or older, diagnosed with locally advanced rectal cancer (stages II or III), and set to receive total neoadjuvant therapy. They need to be able to walk and wear the smartwatch during the treatment period. In total, around 200 patients will take part, and the study will follow them for about 4 to 6 months until their surgery. This research could help improve cancer care by understanding the link between physical activity and treatment outcomes, paving the way for future exercise recommendations for cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.