Breast CancerNCT07331740
Development and Application of a Parenting Anxiety Intervention Program for Young and Middle-Aged Female Breast Cancer Patients
A study testing Parenting Concerns Support Program in people with Breast Cancer and Parenting Anxiety, run by Shanghai University of Traditional Chinese Medicine.
Trial summary
This feasibility study aims to develop and test an intervention program for young and middle-aged female breast cancer patients who experience parenting concerns. Eligible participants will receive the tailored support program (including psychological counseling and parenting guidance). Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Breast Cancer, Parenting Anxiety
- What is being tested?
- Parenting Concerns Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Dec 2026
- 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 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clear breast cancer patients confirmed by histopathology who have received surgical treatment
- Aged 18 to 59 and currently raising at least one minor child under the age of 18
- Clinical stage I - IV
- Be aware of the condition, provide informed consent and voluntarily participate in this study
- The patient can cooperate with the research independently and has normal reading, comprehension, thinking and judgment abilities
Who cannot join
- Concurrent with other cancers
- Engaged in psychology work, or having received psychological intervention guidance within the past six months
- Participate in other nursing intervention studies simultaneously
About this study
Official title: Parenting Concerns of Young and Middle-aged Women With Breast Cancer: A Study Protocol for a Feasibility Trial
This feasibility study aims to develop and test an intervention program for young and middle-aged female breast cancer patients who experience parenting concerns. Eligible participants will receive the tailored support program (including psychological counseling and parenting guidance). The study will assess whether the program is acceptable, feasible, and potentially helpful in reducing parenting concerns among this group.We plan to enroll 20 participants from Shanghai Zhoupu Hospital between March 2026 and October 2026.
- Conditions
- Breast Cancer, Parenting Anxiety
- Being tested
- Parenting Concerns Support Program
- Keywords
- Young and middle-aged female breast cancer patients, Intervention program, Feasibility trial, Parenting Anxiety
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Concerns Support ProgramBehavioural
A 6-week program including 2 individual psychological counseling sessions and 4 group parenting guidance activities, designed to reduce parenting concerns in young and middle-aged female breast cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Concerns Intervention Group | Experimental | All eligible participants will receive the tailored parenting concerns intervention program. Receives: Behavioral: Parenting Concerns Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Concerns Scale for Breast Cancer Patients
This scale was developed by Qian Meiyan et al. in 2024 to assess the parenting anxiety level of breast cancer patients. The scale mainly consists of 5 dimensions and 25 items, namely disease communication (5 items), children's health (4 items), children's emotions (6 items), role communication (6 items), and family support (4 items).
Measured: Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended
Secondary outcomes (2)
Parenting Sense of Competence Scale
This scale was created by Gibaud-Wallston in 1977, aiming to assess the self-perception and confidence level of caregivers.
Measured: Baseline (pre-intervention), 6 weeks post-intervention (end of the program) and One month after the intervention ended
Herth hope index
Compiled by American scholar Herth in 1991, it is applicable to the survey of hope levels among healthy or sick adults. This scale continues to consist of 3 dimensions and 12 items, namely positive attitudes towards reality and the future, taking positive actions, and maintaining close relationships with others.
Measured: Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm feasibility trial; all eligible participants receive the parenting anxiety intervention program.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Hanqi, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331740
- Sponsor's protocol ID
- To be assigned
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Concerns of Young and Middle-aged Women With Breast Cancer: A Study Protocol for a Feasibility Trial
- ClinicalTrials.gov ID
- NCT07331740
- Acronym / sponsor ID
- To be assigned
- Conditions
- Breast Cancer, Parenting Anxiety
- Keywords
- Young and middle-aged female breast cancer patients, Intervention program, Feasibility trial, Parenting Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jan 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 feasibility study aims to develop and test an intervention program for young and middle-aged female breast cancer patients who experience parenting concerns. Eligible participants will receive the tailored support program (including psychological counseling and parenting guidance). The study will assess whether the program is acceptable, feasible, and potentially helpful in reducing parenting concerns among this group.We plan to enroll 20 participants from Shanghai Zhoupu Hospital between March 2026 and October 2026.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm feasibility trial; all eligible participants receive the parenting anxiety intervention program.
| Arm | Type | Receives |
|---|---|---|
| Parenting Concerns Intervention Group | Experimental | Behavioral: Parenting Concerns Support ProgramAll eligible participants will receive the tailored parenting concerns intervention program. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clear breast cancer patients confirmed by histopathology who have received surgical treatment
- Aged 18 to 59 and currently raising at least one minor child under the age of 18
- Clinical stage I - IV
- Be aware of the condition, provide informed consent and voluntarily participate in this study
- The patient can cooperate with the research independently and has normal reading, comprehension, thinking and judgment abilities
Key exclusion criteria (3 listed)
- Concurrent with other cancers
- Engaged in psychology work, or having received psychological intervention guidance within the past six months
- Participate in other nursing intervention studies simultaneously
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 |
|---|---|---|
| Parenting Concerns Support ProgramA 6-week program including 2 individual psychological counseling sessions and 4 group parenting guidance activities, designed to reduce parenting concerns in young and middle-aged female breast cancer patients. | Behavioural | Parenting Concerns Intervention Group |
Primary outcome
Parenting Concerns Scale for Breast Cancer Patients
Time frame: Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended
This scale was developed by Qian Meiyan et al. in 2024 to assess the parenting anxiety level of breast cancer patients. The scale mainly consists of 5 dimensions and 25 items, namely disease communication (5 items), children's health (4 items), children's emotions (6 items), role communication (6 items), and family support (4 items).
2 secondary outcomes
Parenting Sense of Competence Scale
Time frame: Baseline (pre-intervention), 6 weeks post-intervention (end of the program) and One month after the intervention ended
Herth hope index
Time frame: Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended
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 12 Jan 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 Parenting Concerns Support Program in people with Breast Cancer and Parenting Anxiety, run by Shanghai University of Traditional Chinese Medicine.
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 5 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: opening soon, as of the sponsor's last update on 12 Jan 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?
Parenting Concerns Scale for Breast Cancer Patients (time frame: Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended). 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 12 Jan 2026.