Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT06668402
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06668402
Study Brief:
Protocol Section:
NCT06668402