Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059120) titled 'Study to promote postoperative physical activity in colorectal cancer patients' on Oct. 6.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Kyushu University
Condition:
Condition - Colorectal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - 1. To implement a comprehensive intervention for colorectal cancer patients undergoing surgery, consisting of nurse-led physical activity guidance, goal setting, and self-monitoring, aimed at promoting postoperative physical activity, and to evaluate changes in physical activity at 3 months and 6 months after surgery.
2. To explore and quantitatively assess the effects of the intervention by referencing data from participants in previous observational studies.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Nurse-led physical activity guidance
Individualized goal setting for physical activity
Self-monitoring using wearable device
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients undergoing colorectal cancer resection at Kyushu University Hospital
2.Patients aged 18 years or older at the time of obtaining consent
3.Patients who fully understand the study protocol and are capable of providing informed consent
4.Patients who provide written informed consent
5.Patients who have lived at home for at least four days prior to the day of hospital admission for surgery
Key exclusion criteria - 1.Patients unable to complete a self-administered questionnaire in Japanese
2.Patients with limitations in physical activity or difficulty performing activities due to treatment or comorbidities
3.Patients who do not have a device capable of downloading the Fitbit app
4.Patients whom the attending physician judges as unsuitable for study participation due to severe comorbidities or complications
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 03 Day
Date of IRB - 2025 Year 09 Month 03 Day
Anticipated trial start date - 2025 Year 10 Month 06 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067622
Disclaimer: Curated by HT Syndication.