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NCT Number: NCT06566937

The Effectiveness of E-health Intervention in Improving Mental Health Outcomes Among Breast Cancer Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Kanser Negara

Putrajaya, 62250, Malaysia

Location status: Recruiting

Location contact

Azmawati Mohammed Nawi

PRINCIPAL_INVESTIGATOR

Idayu Badilla Idrus

SUB_INVESTIGATOR

Nik Ruzyanei Nik Jaafar

SUB_INVESTIGATOR

Nur Liyana Shamsudin

CONTACT

[email protected]

60174203728

Nur Liyana Shamsudin

SUB_INVESTIGATOR

Nurdiana Hussin

SUB_INVESTIGATOR

Suhana Yusak

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

E-health video

Other

Length: The video is approximately 10-15 minutes long, making it concise and easy to watch in one sitting.

Visuals: Includes engaging visuals, such as animations, graphics, and real-life footage, to illustrate key concepts and keep viewers engaged.

Tone: The tone is supportive, empathetic, and empowering, aiming to create a positive and encouraging atmosphere.

Primary outcomes

  1. Mental Help-Seeking Intention

    Time frame: baseline, 4 weeks and 12 weeks post intervention

    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.

  2. Mental Help-Seeking Behaviour

    Time frame: baseline, 4 weeks and 12 weeks post intervention

    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

Secondary outcomes

  1. Mental Health Literacy

    Time frame: baseline, 4 weeks and 12 weeks post intervention

    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)

  2. Attitude of Seeking Help, Subjective Norms, Perceived Behavioural Control (PBC)

    Time frame: baseline, 4 weeks and 12 weeks post intervention

    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.

  3. Self-stigma of seeking help

    Time frame: baseline, 4 weeks and 12 weeks post intervention

    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

  4. Anxiety and Depression

    Time frame: baseline, 4 weeks and 12 weeks post intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Azmawati Nawi

CONTACT

[email protected]

60193131340

Nurdiana Hussin

CONTACT

[email protected]

60167734458

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

The Development and Effectiveness of E-health Videos in Improving Mental Help-seeking Intention and Behaviour Among Breast Cancer Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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