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

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

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.