Breast CancerNCT06566937
The Effectiveness of E-health Intervention in Improving Mental Health Outcomes Among Breast Cancer Patients
A study testing E-health video in people with Breast Cancer and Breast Neoplasms, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Depression, Anxiety
- What is being tested?
- E-health video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Aug 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Institut Kanser Negara
Putrajaya, 62250
Nur Liyana Shamsudin, 60174203728, whiterosesmy@gmail.com
Nurdiana Hussin
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- E-health video
- Keywords
- telemedicine, e-health, help-seeking intention, behaviour
- Medical subject headings
- Breast Neoplasms, Depression, Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-health videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this group will receive the e-health intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline, 4 weeks and 12 weeks post intervention
Secondary outcomes (4)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: baseline, 4 weeks and 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start9 Aug 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azmawati Mohammed Nawi, Principal investigator, The National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566937
- Sponsor's protocol ID
- JEP-2024-400
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Effectiveness of E-health Videos in Improving Mental Help-seeking Intention and Behaviour Among Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06566937
- Acronym / sponsor ID
- JEP-2024-400
- Keywords
- telemedicine, e-health, help-seeking intention, behaviour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: E-health videoParticipants in this group will receive the e-health intervention |
| Control | No intervention | –Participants in the control group will receive standard care and Ministry of Health pamphlets without the digital intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-health videoLength: 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. | Other | Intervention |
Primary outcome
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.
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
4 secondary outcomes
Mental Health Literacy
Time frame: 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
Self-stigma of seeking help
Time frame: baseline, 4 weeks and 12 weeks post intervention
Anxiety and Depression
Time frame: baseline, 4 weeks and 12 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azmawati Mohammed Nawi principal investigator
The National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-health video in people with Breast Cancer and Breast Neoplasms, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azmawati Nawi (60193131340, azmawati@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Help-Seeking Intention (time frame: baseline, 4 weeks and 12 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.