Breast CancerNCT07883109
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
A study testing Psychosocial Support Program in people with Breast Cancer, run by Mei Man.
Trial summary
This study will evaluate a podcast-based psychosocial support program for women who have been newly diagnosed with breast cancer. The program is designed to provide accessible information and psychological support during the period between diagnosis and the start of cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Psychosocial Support Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 20 years or older.
- Newly diagnosed with breast cancer based on histopathological or cytological confirmation.
- Have not yet received breast cancer-related treatment or breast cancer surgery.
Who cannot join
- -
About this study
Official title: A Podcast-Based Psychosocial Support Program for Women Newly Diagnosed With Breast Cancer: A Nonrandomized Controlled Study
This study will evaluate a podcast-based psychosocial support program for women who have been newly diagnosed with breast cancer. The program is designed to provide accessible information and psychological support during the period between diagnosis and the start of cancer treatment.
Participants will be assigned to either an experimental group or a control group. Participants in the experimental group will receive a series of podcast episodes addressing common concerns related to breast cancer diagnosis and treatment, psychological adjustment, and coping. Participants in the control group will receive usual care.
Participants will complete questionnaires before the program and approximately 1 month after the intervention. The study will assess changes in anxiety, uncertainty, demoralization, and other psychological outcomes. The findings will help determine whether podcast-based psychosocial support may provide useful support for women adjusting to a new breast cancer diagnosis.
- Conditions
- Breast Cancer
- Being tested
- Psychosocial Support Program
- Keywords
- Breast Cancer Patients
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Support ProgramOther
Also called Behavioral
Participants in the experimental group will access the podcast content during the intervention period in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive the podcast-based psychosocial support program in addition to usual care. The program is designed to support psychological adjustment, reduce Receives: Other: Psychosocial Support Program |
| Control Group | No intervention | Participants will receive usual care without the podcast-based psychosocial support program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Symptoms Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), which consists of 7 items. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21 points. Higher scores indicate greater anxiety symptoms. The outcome measure is the HADS-A total score, expressed in points.
Measured: Baseline and approximately 1 month after the intervention
Depressive Symptoms Measured by the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)
Depressive symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), which consists of 7 items. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21 points. Higher scores indicate greater depressive symptoms. The outcome measure is the HADS-D total score, expressed in points.
Measured: At baseline before the intervention and 1 month after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Man
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor-investigator, Mei Man, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883109
- Sponsor's protocol ID
- A202605075
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Podcast-Based Psychosocial Support Program for Women Newly Diagnosed With Breast Cancer: A Nonrandomized Controlled Study
- ClinicalTrials.gov ID
- NCT07883109
- Acronym / sponsor ID
- A202605075
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mei ManUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
This study will evaluate a podcast-based psychosocial support program for women who have been newly diagnosed with breast cancer. The program is designed to provide accessible information and psychological support during the period between diagnosis and the start of cancer treatment.
Participants will be assigned to either an experimental group or a control group. Participants in the experimental group will receive a series of podcast episodes addressing common concerns related to breast cancer diagnosis and treatment, psychological adjustment, and coping. Participants in the control group will receive usual care.
Participants will complete questionnaires before the program and approximately 1 month after the intervention. The study will assess changes in anxiety, uncertainty, demoralization, and other psychological outcomes. The findings will help determine whether podcast-based psychosocial support may provide useful support for women adjusting to a new breast cancer diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Psychosocial Support ProgramParticipants will receive the podcast-based psychosocial support program in addition to usual care. The program is designed to support psychological adjustment, reduce |
| Control Group | No intervention | –Participants will receive usual care without the podcast-based psychosocial support program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 20 years or older.
- Newly diagnosed with breast cancer based on histopathological or cytological confirmation.
- Have not yet received breast cancer-related treatment or breast cancer surgery.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Psychosocial Support ProgramAlso: BehavioralParticipants in the experimental group will access the podcast content during the intervention period in addition to usual care. | Other | Experimental Group |
Primary outcome
Anxiety Symptoms Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Time frame: Baseline and approximately 1 month after the intervention
Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), which consists of 7 items. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21 points. Higher scores indicate greater anxiety symptoms. The outcome measure is the HADS-A total score, expressed in points.
Depressive Symptoms Measured by the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)
Time frame: At baseline before the intervention and 1 month after the intervention.
Depressive symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), which consists of 7 items. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21 points. Higher scores indicate greater depressive symptoms. The outcome measure is the HADS-D total score, expressed in points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Support Program in people with Breast Cancer, run by Mei Man.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) (time frame: Baseline and approximately 1 month after the 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 26 Oct 2026.