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

August 19, 2024 updated by: National University of Malaysia

The Development and Effectiveness of E-health Videos in Improving Mental Help-seeking Intention and Behaviour 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Putrajaya, Malaysia, 62250
        • Recruiting
        • Institut Kanser Negara
        • Sub-Investigator:
          • Nik Ruzyanei Nik Jaafar
        • Contact:
        • Sub-Investigator:
          • Nurdiana Hussin
        • Principal Investigator:
          • Azmawati Mohammed Nawi
        • Sub-Investigator:
          • Idayu Badilla Idrus
        • Sub-Investigator:
          • Nur Liyana Shamsudin
        • Sub-Investigator:
          • Suhana Yusak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants in this group will receive the e-health intervention
Other: E-health video

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.
No Intervention: Control
Participants in the control group will receive standard care and Ministry of Health pamphlets without the digital intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 4 weeks and 12 weeks post intervention
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
baseline, 4 weeks and 12 weeks post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline, 4 weeks and 12 weeks post intervention
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.
baseline, 4 weeks and 12 weeks post intervention
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
baseline, 4 weeks and 12 weeks post intervention
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
baseline, 4 weeks and 12 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Azmawati Mohammed Nawi, The National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEP-2024-400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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