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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Nethersole School of Nursing

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention Group

    Other intervention

    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

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: mHealth survivorship programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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))

Secondary outcomes

1

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))
2

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))
3

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))
4

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))

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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