Nutrition and Exercise Program for Elderly Colorectal Cancer Patients
NCT Number: NCT06502275
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer
Interventions: BEHAVIORAL: Mobile Health Management Frailty Care Program
Sponsor: Chang Gung University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-01
Completion Date: 2025-09-30
Locations: Chang Gung Memorial Hospital, Chiayi City, Taiwan

Summary:
The goal of this interventional study is to evaluate the effect of mobile health intervention on frailty, physical fitness, physical activity, and nutritional status of elderly patients with colorectal cancer. The main questions it aim to answer are: 1. Does the mobile health intervention reduce frailty in elderly colorectal cancer patients compared to standard care? 2. Does the mobile health intervention improve physical fitness, physical activity, and nutritional status in elderly colorectal cancer patients compared to standard care? Participants will receive the Mobile Health Management Frailty Care Program.

Primary Outcome Measures: Frailty, Assessing frailty status using the G8 geriatric screening tool. Scores range from 0 to 17, with 0 indicating severe impairment and 17 indicating no impairment. The lower the score, the more frail it is., Pre-test, sixth week after intervention, 13th week after intervention|Physical Activity, Assess physical activity with the International Physical Activity Questionnaire-Short Form. The IPAQ-SF evaluates the number of days and time spent performing MVPA, walking, and sitting in bouts of at least 10 min over the previous 7 days. The summary score is expressed in PA metabolic equivalent of task (MET)-min per day or week., Pre-test, sixth week after intervention, 13th week after intervention|Nutritional Status, Assess nutritional status with Mini Nutritional Assessment-Short Form. The total score is 0-14 points. A score of 12 or more indicates a low risk of malnutrition. A score of 8-11 indicates a potential risk of malnutrition. A score less than 7 indicates a high risk of malnutrition., Pre-test, sixth week after intervention, 13th week after intervention
Secondary Outcome Measures: health-related quality of life, Assessing quality of life using Taiwan Chinese version of European Organization for Research and Treatment of Cancer questionnaires. For all scales, item scores are summed and linearly transformed into a scale ranging from 0 to 100. Higher scores on the functioning scales indicate higher levels of functioning, Pre-test, sixth week after intervention, 13th week after intervention|Depression, Assessing depression level using the Geriatric Depression Scale Short Form. The higher the score, the higher the degree of depression. 0-4 indicates normal, 5-10 indicates slight tendency to depression, and 10 or more indicates symptoms of depression., Pre-test, sixth week after intervention, 13th week after intervention|body mass index, Body mass index is calculated by dividing weight (kg) by height (meters) squared. The normal range is 18.5 ≦ BMI \< 24. Less than 18.5 represents underweight; 24 ≦ BMI \<27 represents overweight; 27 ≦ BM I\<30 represents mild obesity; 30 ≦ BMI \<35 represents moderate obesity; BMI ≧35 represents severe obesity., Pre-test, sixth week after intervention, 13th week after intervention|hand grip strength, Hand grip strength (in kilograms) was measured using a digital hand dynamometer (EH101; Camry, Guangdong Province, China). The grip strength of the dominant hand was assessed three times, and the maximal value was considered for analysis. The definition of normal GS according to European Working Group on Sarcopenia in Older People (EWGSOP) was ≥ 30kg in the male and ≥ 20 kg in the female. Weak GS was defined as GS \< 30 kg in the male and GS \< 20 kg in the female., Pre-test, sixth week after intervention, 13th week after intervention|walking speed, Walking speed was measured with a 4-meter walking evaluation with a static start. The 4-m gait speed was assessed to the nearest 0.01 s using a stopwatch. Participants were instructed to walk at their comfortable speed. Walking distance exceeded the required four meters to prevent participants from slowing down before reaching the 4-m line. The fastest time of two trials was used for analyses and gait speed was expressed in m/s. The 0.8 m/s cut-point was used to represent a slow walking speed., Pre-test, sixth week after intervention, 13th week after intervention