Application of lifelog-based physical activity and nutritional intervention for minimizing postoperative weight-loss among esophageal cancer patients.
- Conditions
- Neoplasms
- Registration Number
- KCT0006446
- Lead Sponsor
- ational Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 94
Those who have been diagnosed with esophageal cancer and are over the age of 18 who are scheduled to undergo curative esophageal resection and reconstruction, and are under 80 years of age
– Able to walk independently and live daily life
- ECOG PS 0-1
– Those who can use a smartphone
– Those who signed on the written informed consent to this study
- Those who have limited cognitive and communication skills or are currently receiving psychiatric treatment
– Those who have had esophageal cancer treatment (surgery) within the last 1 year (excluding local treatments such as endoscopic resection)
– Those who have previously had esophageal resection and reconstructive surgery
– Those who are overseas residents or foreigners, and cannot be continuously followed
– Those who are with limited physical ability to perform this intervention program:
1) Cardiac failure (New York Heart Association functional classes III and IV)) due to cardiovascular disease or cerebrovascular disease (cerebral hemorrhage, cerebral infarction, transient ischemic attack, stroke, cerebrovascular accident) If you are concerned about the worsening of the disease.
2) Patients unable to walk due to joint problems or paralysis
3) Patients with kidney dysfunction(estimated GFR<60mL/min/1.73m^2)
4) Patients who failed to proceeding to suffiecient oral intake postoperatively
5) Patients who did not meet the oral intake initiation within 14 days after surgery
*Indication for drop-out: Inhospitalization more than 30-day after surgery since postoperative complication
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of severe weight loss (= 10% comparing to pre-surgery weight)
- Secondary Outcome Measures
Name Time Method 1) Body weight (kg), body fat percentage (%), skeletal muscle mass index (SMI, kg/m2) measured by Bioelectrical impedance analysis (BIA), abdominal SMI(kg/m2) at lumbar 3 level and abdominal body fat percentage (%) measured by CT ;2) Quality of life and symptoms: EORTC QLQ-C30 & OES18, GSRS, depression (PHQ9) , Distress(NCCN distress thermometer and problem list); 3) Nutritional indicators (Lab): PNI, NRI (e.g. albumin, total protein, Hb, WBC, ANC, ALC, platelet, NLR, PLR); 4) Nutritional evaluation score: NRS-2002, MNA-SF, dietary habit (intake questionnaire, nutrition counseling), amount of oral intake(kcal, protein); 5) Physical function: grip (kg), 6MWT (m), CS (rep), physical activity level (step, MVPA during last 7-day);6) Complications within 2 months after surgery