The Effectiveness of E-health Intervention in Improving Mental Health Outcomes Among Breast Cancer Patients
NCT Number: NCT06566937
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Breast Neoplasms|Depression, Anxiety|Distress, Emotional
Interventions: OTHER: E-health video
Sponsor: National University of Malaysia
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-09
Completion Date: 2026-09-30
Locations: Institut Kanser Negara, Putrajaya, 62250, Malaysia

Summary:
Study Purpose: The study aims to assess how effective e-health interventions are at improving mental health help-seeking intentions and behaviours among breast cancer patients.

Intervention: E-health interventions will be utilized to encourage patients to seek mental health support. These interventions are designed to be accessible and convenient, offering support and information through digital platforms.

Participants: The study will involve breast cancer patients between the ages of 18 and 65.

Key Objectives:

Primary Goal: To measure any changes in patients' intentions and actions to seek mental health support before and after using e-health interventions.

Secondary Goals: To explore how these interventions impact mental health literacy, reduce self-stigma, and identify barriers and facilitators to seeking help.

Comparison: The study will compare outcomes for patients using e-health tools against those receiving traditional care without digital interventions.

Expected Outcomes: Researchers anticipate that e-health interventions will improve mental health help-seeking behaviours, enhance understanding of mental health issues, and reduce the stigma associated with seeking support.

Significance: This study could demonstrate the potential of digital health tools to support mental well-being among breast cancer patients, providing new ways to access care and overcome traditional barriers to seeking mental health support.

Primary Outcome Measures: Mental Help-Seeking Intention, Help-Seeking Intention: The likelihood or willingness of breast cancer patients to seek professional mental health services.

The mental help-seeking intention will be assessed using the Theory of Planned Behaviour (TPB) questionnaires. The help-seeking intention will be measured on a 3-item scale. Responses will be rated on a 6-point Likert scale, with higher scores indicating higher levels of help-seeking intention., baseline, 4 weeks and 12 weeks post intervention|Mental Help-Seeking Behaviour, The actual actions participants took to seek mental health services, such as contacting a mental health professional or accessing online resources.

Mental help-seeking behaviour will be assessed by their behaviour of seeking or not seeking help, the answer will be yes or no, baseline, 4 weeks and 12 weeks post intervention
Secondary Outcome Measures: Mental Health Literacy, Mental health literacy refers to the knowledge and beliefs about mental disorders that aid in their recognition, management, and prevention. Evaluation: Mental Health Literacy Scale (MHLS), baseline, 4 weeks and 12 weeks post intervention|Attitude of Seeking Help, Subjective Norms, Perceived Behavioural Control (PBC), Attitude towards help-seeking, subjective norms, as well as PBC, will be assessed using the TPB questionnaires

Perceived behavioural control - PBC will be measured on a 3-item scale. Responses will be rated on a 6-point Likert scale, with higher scores indicating higher levels of behavioural control

Subjective norms - The subjective norm will be measured on a 3-item scale. Responses will be rated on a 6-point Likert scale, with higher scores indicating higher levels of subjective norm.

Attitude towards help-seeking - This aspect will be assessed using 5 items, which will then be evaluated on a 6-point semantic differential scale, where higher scores denote a more favourable attitude towards help-seeking., baseline, 4 weeks and 12 weeks post intervention|Self-stigma of seeking help, Self-stigma refers to the internalized negative perceptions and shame associated with seeking mental health support. Self-stigma in seeking help will be assessed using the Self-Stigma of Seeking Help (SSOSH) questionnaire, baseline, 4 weeks and 12 weeks post intervention|Anxiety and Depression, The level of anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS). HADS is a self-reported questionnaire designed to screen anxiety and depressive in a hospital setting, baseline, 4 weeks and 12 weeks post intervention