The Effectiveness of the mHealth Survivorship Program on Enhancing Health-related Quality of Life Among Colorectal Cancer Survivors

NCT ID: NCT07158671

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-30

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

Detailed Description

Cancer is the second leading cause of global mortality, with colorectal cancer (CRC) ranking third in deaths and diagnoses for both genders. There are more and more survivors who have completed treatment, improving survival rates and emphasizing the need for ongoing support. CRC survivors face challenges due to a lack of healthcare support, which can reduce their quality of life (QoL). The Institute of Medicine (IOM) recommends specialized survivorship programmes for CRC survivors. The American Cancer Society (ACS) has also issued comprehensive guidelines for CRC survivorship care. Evidence suggests that integrating a mobile application can improve resource coordination for survivors in remote areas, enhancing QoL. Thus, developing mHealth-based survivorship programs aligned with ACS guidelines is crucial for improving health-related QoL in this population.

Briefly, as a result of a systematic review and meta-analysis, we identified two key features of the available survivorship programmes and their efficacy in enhancing health-related QoL. First, many programmes have methodological weaknesses, with few studies adequately reporting allocation concealment or non-blinding. Only 7 out of 22 studies were grounded in different theoretical frameworks, and none were conducted in developing countries. Second, each programme was often treated in isolation, and the contents followed the ACS guidelines. They emphasise health promotion and managing late side effects over surveillance for second cancers and care coordination. Key components include: 1) CRC education on symptom management, nutrition, and exercise; 2) expert health coaching with survivorship care plans, delivered over 12 weeks, averaging 30-45 minutes, 6 to 12 sessions weekly; delivered mobile health, led by nurses. From these gaps, rigorous studies are warranted to integrate these contents to lay the foundation for future comprehensive interventions via mobile health, which can address multiple domains to improve the health-related QoL for this population.

This study will adopt a randomised controlled trial (RCT) design. A total of 210 participants will be recruited, including 50 participants for pilot RCT and 160 participants for the main RCT. Participants in the intervention group will receive the mHealth survivorship programme, and participants in the control group will receive usual care. Outcomes will be measured at four timepoints: recruitment (T0), immediately post-intervention (T1), 1-month follow-up (T2). For data analysis, ITT analyses will be conducted. All the statistical analyses will be performed via R, and the significance level of 0.05 will be set.

Conditions

Colorectal Cancer (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants in the control group will receive the usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

mHealth survivorship program

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

Group Type: ACTIVE_COMPARATOR

Intervention Group

Intervention Type: OTHER

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

Interventions

Intervention 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Nethersole School of Nursing

OTHER

Sponsor Role: lead

Responsible Party

Do Pham Nhat Vi

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Do Pham Nhat Vi, PhD Student

Role: CONTACT

vido@link.cuhk.edu.hk

(852) 67455170

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2025.327

Identifier Type: -

Identifier Source: org_study_id