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mHealth Program for Quality of Life in Colorectal Cancer Survivors

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What is being tested

Intervention Group

Other
Who is being recruted

Colorectal Cancer (Diagnosis)

Over 18 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorThe Nethersole School of Nursing
Study ContactDo Pham Nhat Vi, PhD Student
Last updated: September 8, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual date on which the first participant was enrolled.

This study is focused on improving the quality of life for people who have survived colorectal cancer. As the number of colorectal cancer survivors grows, many face challenges in maintaining a good quality of life due to limited healthcare support. This is particularly important because colorectal cancer is one of the most common cancers worldwide. The study aims to use a mobile health program, which follows guidelines from well-respected organizations like the American Cancer Society, to provide ongoing support and resources. By doing so, the study hopes to address the gaps in current care and improve the overall well-being of survivors. Participants in this study will be divided into two groups. One group will use the new mobile health program, while the other group will continue with their usual care. This app-based program will offer education on managing symptoms, nutrition, and exercise, as well as health coaching from nurses. The study will involve 210 participants and measure their progress at different times: when they start the study, right after the program ends, and one month later. The effectiveness of the program will be analyzed using statistical methods to ensure that the results are reliable. This approach aims to provide a more comprehensive support system for colorectal cancer survivors.

Official TitleThe Effectiveness of the mHealth Survivorship Program on Enhancing Health-related Quality of Life Among Colorectal Cancer Survivors: Randomised Controlled Trial 
Principal SponsorThe Nethersole School of Nursing
Study ContactDo Pham Nhat Vi, PhD Student
Last updated: September 8, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
210 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer (Diagnosis)
Criteria
5 inclusion criteria required to participate
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)

Show More Criteria

2 exclusion criteria prevent from participating
mental health diseases
receiving anxiety or depression treatment or cognitive/learning problems

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
No Intervention
Participants in the control group will receive the usual care
Group II
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
Study Objectives
Primary Objectives

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
Secondary Objectives

A self-report tool measuring distress on a scale from 0 (no distress) to 10 (extreme distress), focusing on a cutoff score of 4

Consists of 21 items, with seven items for anxiety (DASS21-A), seven items for depression (DASS21-D) and seven items for stress (DASS21-S). It was validated for use in the Vietnamese population with good internal consistency (Cronbach's alpha: depression subscale-0.72; anxiety subscale-0.77; stress subscale-0.70, and overall scale-0.88).

with 13 items, likert scales from 0 (not at all) to 4 (ver much), which has been validated for use in the Vietnamese version with Cronbach's alpha coefficient α = 0.93

A 5-question questionnaire evaluated bowel functional symptoms. Scores were assigned to responses, determining the LARS score, which categorized results into "no LARS" (0-20), "minor LARS" (21-29), and "major LARS" (30-42). Cronbach's alpha was from 0.874 to 0.934

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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