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

NCT06566937 | Recruiting DMC

• 1 other identifier: JEP-2024-400
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Depression, Anxiety; Distress, Emotional

Keywords

telemedicine; e-health; help-seeking intention; behaviour

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mental Health Literacy

  baseline, 4 weeks and 12 weeks post intervention

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

  baseline, 4 weeks and 12 weeks post intervention

• Self-stigma of seeking help

  baseline, 4 weeks and 12 weeks post intervention

• Anxiety and Depression

  baseline, 4 weeks and 12 weeks post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this group will receive the e-health intervention

Other: E-health video

Control

NO INTERVENTION

Participants in the control group will receive standard care and Ministry of Health pamphlets without the digital intervention

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Institut Kanser Negara

Putrajaya, 62250, Malaysia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Depression; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Mental Disorders

Study Officials

• Azmawati Mohammed Nawi

  The National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azmawati Nawi

CONTACT

60193131340; azmawati@ppukm.ukm.edu.my

Nurdiana Hussin

CONTACT

60167734458; dr.nurdiana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 22, 2024
• Study Start: August 9, 2024
• Primary Completion: September 30, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)