Development and Application of a Parenting Anxiety Intervention Program for Young and Middle-Aged Female Breast Cancer Patients
January 9, 2026 updated by: Hu Hanqi, Shanghai University of Traditional Chinese Medicine
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parenting Concerns Intervention Group
All eligible participants will receive the tailored parenting concerns intervention program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
This scale was created by Gibaud-Wallston in 1977, aiming to assess the self-perception and confidence level of caregivers.
|
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
|
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.
|
Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
March 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 29, 2025
First Submitted That Met QC Criteria
January 9, 2026
First Posted (Estimated)
January 12, 2026
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
January 9, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- To be assigned (EGMS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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