Colorectal CancerNCT06502275
Nutrition and Exercise Program for Elderly Colorectal Cancer Patients
A study testing Mobile Health Management Frailty Care Program in people with Colorectal Cancer, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Mobile Health Management Frailty Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Chiayi City
Ching-Ching Su, PhD, 886+53628800 ext. 2202, ccsu@mail.cgust.edu.tw
About this study
Official 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
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.
- Conditions
- Colorectal Cancer
- Being tested
- Mobile Health Management Frailty Care Program
- Keywords
- Older, Colorectal cancer, Frailty, mobile health, Physical activity, nutrition
- Medical subject headings
- Colorectal Neoplasms, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Management Frailty Care ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition combined with exercise group | Experimental | Provide mobile health interventions that combine nutrition and exercise Receives: Behavioral: Mobile Health Management Frailty Care Program |
| routine care group | No intervention | Provide routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-test, sixth week after intervention, 13th week after intervention
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-test, sixth week after intervention, 13th week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Feb 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Ching Su, Chang Gung University of Science and Technology
- Investigators
- Ching-Ching Su, PhD, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502275
- Sponsor's protocol ID
- 202300957B0C601
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06502275
- Acronym / sponsor ID
- 202300957B0C601
- Conditions
- Colorectal Cancer
- Keywords
- Older, Colorectal cancer, Frailty, mobile health, Physical activity, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition combined with exercise group | Experimental | Behavioral: Mobile Health Management Frailty Care ProgramProvide mobile health interventions that combine nutrition and exercise |
| routine care group | No intervention | –Provide routine care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health Management Frailty Care ProgramThrough 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. | Behavioural | Nutrition combined with exercise group |
Primary outcome
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.
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.
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.
5 secondary outcomes
health-related quality of life
Time frame: Pre-test, sixth week after intervention, 13th week after intervention
Depression
Time frame: Pre-test, sixth week after intervention, 13th week after intervention
body mass index
Time frame: Pre-test, sixth week after intervention, 13th week after intervention
hand grip strength
Time frame: Pre-test, sixth week after intervention, 13th week after intervention
walking speed
Time frame: Pre-test, sixth week after intervention, 13th week after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Ching Su, PhD principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Management Frailty Care Program in people with Colorectal Cancer, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Ching Su, PhD (886+912649476, ccsu@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: Pre-test, sixth week after intervention, 13th week after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.