Clinical trial NCT06566937: The Effectiveness of E-health Intervention in Improving Mental Health Outcomes Among Breast Cancer Patients
Official title: The Development and Effectiveness of E-health Videos in Improving Mental Help-seeking Intention and Behaviour Among Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Depression, Anxiety
Distress, Emotional
Keywords: telemedicine
e-health
help-seeking intention
behaviour
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group: Participants in this group will receive the e-health intervention.

Control Group: Participants in the control group will receive standard care without the digital intervention.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Study Objective: The study seeks to explore how digital health interventions can enhance the willingness and actions of breast cancer patients to seek mental health support. With the rise of digital technology, there is a growing interest in how these tools can bridge gaps in healthcare access and provide timely support.

Context and Background: Breast cancer patients often face significant emotional and psychological challenges, which can affect their overall well-being and treatment outcomes. Traditional mental health services may not always be accessible due to physical, geographic, or psychological barriers. E-health interventions present an innovative solution by offering support through digital platforms that patients can access from the comfort of their homes.

Digital Interventions: These tools are designed to provide information, support, and motivation, encouraging patients to engage in mental health services.

Methodology:

Participants: The study will recruit breast cancer patients aged 18 to 65, providing a diverse representation of those affected by the condition.

Implementation: Participants will use digital interventions over a specified period, with regular assessments to monitor changes in their mental health help-seeking behaviours and intentions.

Data Collection: Researchers will track metrics such as changes in self-reported mental health literacy, attitudes toward seeking help, self-stigma on seeking help and mental help-seeking intention score.

Comparative Analysis: The study will include a control group receiving standard care without digital interventions to compare outcomes and measure the effectiveness of e-health tools.

Anticipated Benefits:

Accessibility: E-health tools can offer immediate access to resources and support, overcoming barriers such as distance and mobility.

Personalization: Digital platforms can tailor content and support to meet individual needs, enhancing engagement and effectiveness.

Empowerment: By providing information and resources, e-health interventions can empower patients to take proactive steps in managing their mental health.

Significance: The findings from this study could have significant implications for healthcare delivery, demonstrating the value of integrating digital solutions into patient care. Successful implementation of e-health interventions could lead to widespread adoption, improving mental health outcomes for breast cancer patients and potentially other patient groups facing similar challenges.

Conclusion: By leveraging the power of digital technology, this study aims to transform the landscape of mental health support for breast cancer patients, offering new pathways to care that is accessible, effective, and patient-centred.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients from all stages of the disease who are currently undergoing treatment at Institut Kanser Negara (IKN)
* Age 18 years and above
* Patients willing to participate
* Patients understand either Malay or English language

Exclusion Criteria:

* Patients with breast cancer and metastasis to the brain
* Patients who are diagnosed with mental illness
* Patients with performance status 3 and above (based on The Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status)

Primary outcomes:
measure: Mental Help-Seeking Intention
timeFrame: baseline, 4 weeks and 12 weeks post intervention
measure: Mental Help-Seeking Behaviour
timeFrame: baseline, 4 weeks and 12 weeks post intervention
Secondary outcomes:
measure: Mental Health Literacy
timeFrame: baseline, 4 weeks and 12 weeks post intervention
measure: Attitude of Seeking Help, Subjective Norms, Perceived Behavioural Control (PBC)
timeFrame: baseline, 4 weeks and 12 weeks post intervention
measure: Self-stigma of seeking help
timeFrame: baseline, 4 weeks and 12 weeks post intervention
measure: Anxiety and Depression
timeFrame: baseline, 4 weeks and 12 weeks post intervention
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
Study officials:
affiliation: The National University of Malaysia
name: Azmawati Mohammed Nawi
role: PRINCIPAL_INVESTIGATOR
References: