About this 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:
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
mental health diseases;
receiving anxiety or depression treatment or cognitive/learning problems.
Trial design
Parallel
Treatments tested in this trial
Intervention Group
Other interventionParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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).
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
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
Locations
Sponsors and contacts
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