Colorectal Cancer (Diagnosis)NCT07158671
The Effectiveness of the mHealth Survivorship Program on Enhancing Health-related Quality of Life Among Colorectal Cancer Survivors
A study testing Intervention Group in people with Colorectal Cancer (Diagnosis), run by The Nethersole School of Nursing.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (Diagnosis)
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- mental health diseases;
- receiving anxiety or depression treatment or cognitive/learning problems.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of the mHealth Survivorship Program on Enhancing Health-related Quality of Life Among Colorectal Cancer Survivors: Randomised Controlled Trial
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:
Read more
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
Read the 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)
- Being tested
- Intervention Group
- Keywords
- mHealth, Survivorship, Colorectal cancer, Survivors, health-related quality of life
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
A self-report tool measuring distress on a scale from 0 (no distress) to 10 (extreme distress), focusing on a cutoff score of 4
Measured: 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)
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).
Measured: 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)
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
Measured: 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)
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
Measured: Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (Diagnosis)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Nethersole School of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Pham Nhat Vi, The Nethersole School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158671
- Sponsor's protocol ID
- 2025.327
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the mHealth Survivorship Program on Enhancing Health-related Quality of Life Among Colorectal Cancer Survivors: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07158671
- Acronym / sponsor ID
- 2025.327
- Conditions
- Colorectal Cancer (Diagnosis)
- Keywords
- mHealth, Survivorship, Colorectal cancer, Survivors, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The Nethersole School of NursingUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Sep 2025 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in the control group will receive the usual care |
| mHealth survivorship program | Active comparator | Other: Intervention GroupParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- mental health diseases;
- receiving anxiety or depression treatment or cognitive/learning problems.
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 |
|---|---|---|
| Intervention GroupParticipants 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 | mHealth survivorship program |
Primary outcome
The Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))
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
4 secondary outcomes
The distress thermometer screening tool (DT)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post 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 8 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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Colorectal Cancer (Diagnosis), run by The Nethersole School of Nursing.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Do Pham Nhat Vi, PhD Student ((852) 67455170, vido@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Assessment of Cancer Therapy-General (FACT-G) (time frame: Participants will be assessed at three-time points: baseline (Day 1), post-intervention (12 weeks), and 1-month follow-up (after post intervention))). 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 8 Sep 2025.