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.
Behavioral: Parenting Concerns Support 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.

Sponsor

Shanghai University of Traditional Chinese Medicine

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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