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NCT Number: NCT06502275

Nutrition and Exercise Program for Elderly Colorectal Cancer Patients

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location status: Recruiting

Location contact

Ching-Ching Su, PhD

CONTACT

[email protected]

886+53628800 ext. 2202

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Health Management Frailty Care Program

Behavioral

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.

Primary outcomes

  1. Frailty

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

  2. Physical Activity

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

  3. Nutritional Status

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

Secondary outcomes

  1. health-related quality of life

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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

  2. Depression

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

  3. body mass index

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

  4. hand grip strength

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

  5. walking speed

    Time frame: Pre-test, sixth week after intervention, 13th week after intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-Ching Su, PhD

CONTACT

[email protected]

886+912649476

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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