Nutrition and Exercise Program for Elderly Colorectal Cancer Patients

Effects of the Tailored Frailty Prevention Program With Exercise and Nutrition Management to Improve Physical Performance and Health Status in Older Patients With Colorectal Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Mobile Health Management Frailty Care Program

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Ching Su, PhD; Phone Number: 886+912649476; Email: ccsu@mail.cgust.edu.tw

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Ching-Ching Su, PhD; Phone Number: 2202 886+53628800; Email: ccsu@mail.cgust.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients diagnosed with colorectal cancer confirmed by a physician.
• Aged 60 and above.
• Have communication skills, able to read and write or converse in Mandarin and Taiwanese.
• Clear consciousness and no mental or cognitive impairment.
• Physical activities are accessible.
• Those who have a smartphone and have experience using smartphones.

Exclusion Criteria:

• People who have difficulty walking or standing.
• The wrist is not suitable for those wearing sports bracelets.
• People in infectious or protective isolation.
• Those who live alone or in institutions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition combined with exercise group; Provide mobile health interventions that combine nutrition and exercise	Behavioral: Mobile Health Management Frailty Care Program; Through the "LINE" communication software, participants are provided with exercise and nutrition information three times a week, with a total of 36 messages. As well as 6 podcasts of health information and 6 sports videos in total. At weeks 2, 4, and 6, researchers scheduled 5- to 10-minute telephone consultations. Participants can receive guidance through telephone consultations and carry a Xiaomi sports band wearable device to monitor their exercise.
No Intervention: routine care group; Provide routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology
• Investigators: Principal Investigator: Ching-Ching Su, PhD, Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal cancer; mobile health; nutrition; Physical activity; Frailty; Older
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Frailty; Colorectal Neoplasms; Motor Activity
• Other Study ID Numbers: 202300957B0C601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No