NCT07331740

Brief 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). 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

December 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 29, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

Young and middle-aged female breast cancer patientsIntervention programFeasibility trialParenting Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    Baseline (pre-intervention), 6 weeks post-intervention (end of the program) and One month after the intervention ended

  • Herth hope index

    Baseline (pre-intervention) , 6 weeks post-intervention (end of the program) and One month after the intervention ended

Study Arms (1)

Parenting Concerns Intervention Group

EXPERIMENTAL

All eligible participants will receive the tailored parenting concerns intervention program.

Behavioral: Parenting Concerns Support Program

Interventions

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.

Parenting Concerns Intervention Group

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm feasibility trial; all eligible participants receive the parenting anxiety intervention program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student, School of Nursing, Shanghai University of Traditional Chinese Medicine

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 12, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01