NCT06502275

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

July 8, 2024

Last Update Submit

September 12, 2025

Conditions

Keywords

OlderColorectal cancerFrailtymobile healthPhysical activitynutrition

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • health-related quality of life

    Pre-test, sixth week after intervention, 13th week after intervention

  • Depression

    Pre-test, sixth week after intervention, 13th week after intervention

  • body mass index

    Pre-test, sixth week after intervention, 13th week after intervention

  • hand grip strength

    Pre-test, sixth week after intervention, 13th week after intervention

  • walking speed

    Pre-test, sixth week after intervention, 13th week after intervention

Study Arms (2)

Nutrition combined with exercise group

EXPERIMENTAL

Provide mobile health interventions that combine nutrition and exercise

Behavioral: Mobile Health Management Frailty Care Program

routine care group

NO INTERVENTION

Provide routine care

Interventions

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.

Nutrition combined with exercise group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsFrailtyMotor Activity

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ching-Ching Su, PhD

    Chang Gung University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Ching Su, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 16, 2024

Study Start

February 1, 2024

Primary Completion

September 15, 2025

Study Completion

September 30, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations