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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
210
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
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
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 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
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)
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).
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)
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
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)
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
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))
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