NCT07158671

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of the mHealth survivorship program in enhancing health-related quality of life among colorectal cancer survivors. It is hypothesized that participants receiving the mHealth-based survivorship program will report significantly higher levels of health-related quality of life and a lower level of distress, depression, anxiety, fatigue, and bowel dysfunction compared to those in the control group. Participants in the intervention group will: Use the survivorship programme through mHealth every day for 3 months Be called by the healthcare provider every 2 weeks for consultation Participants in the control group will receive the usual care

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

August 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

August 19, 2025

Last Update Submit

September 2, 2025

Conditions

Colorectal Cancer (Diagnosis)

Keywords

mHealthSurvivorshipColorectal cancerSurvivorshealth-related quality of life

Outcome Measures

Primary Outcomes (1)

  • The Functional Assessment of Cancer Therapy-General (FACT-G)

    Assesses health-related QoL, including physical function (consisting of 7 items), social and family relationships (7 items), emotional state (6 items), and functional abilities (7 items). Scores range from 0 to 100, with higher scores indicating better QoL. Cronbach's alpha of 0.89 for the scale, received the approval to use the FACT-G from the FACIT organisation

    Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))

Secondary Outcomes (4)

  • The distress thermometer screening tool (DT)

    Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))

  • The Depression Anxiety Stress Scales (DASS-21)

    Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))

  • The Functional Assessment of Cancer Therapy-Fatigue subscale (FACT-F)

    Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))

  • The Low anterior resection syndrome (LARS)

    Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))

Study Arms (2)

Control group

NO INTERVENTION

Participants in the control group will receive the usual care

mHealth survivorship program

ACTIVE COMPARATOR

Participants in the intervention group will: Use the survivorship programme through mHealth every day for 3 months; Be called by the healthcare provider every 2 weeks for consultation

Other: Intervention Group

Interventions

Intervention GroupOTHER

Participants in the intervention group will: Use the survivorship programme through mHealth every day for 3 months; Be called by the healthcare provider every 2 weeks for consultation

mHealth survivorship program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be 18 or older (1);
  • Vietnamese-speaking CRC patients who have completed active treatment and are preparing for discharge (2);
  • provide consent and complete questionnaires independently (3);
  • no metastatic and second cancers (4);
  • using the Android smartphone (5).

You may not qualify if:

  • mental health diseases;
  • receiving anxiety or depression treatment or cognitive/learning problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsDisease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Do Pham Nhat Vi, PhD Student

CONTACT

(852) 67455170vido@link.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 8, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share