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Clinical Trials/NCT06385665
NCT06385665
Recruiting
Not Applicable

The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer:A Real World Study

Xin Peng1 site in 1 country304 target enrollmentApril 22, 2024
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Xin Peng
Enrollment
304
Locations
1
Primary Endpoint
Change from Baseline meatal state on GAD-7 at Week 48.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:

  1. Patients with advanced breast cancer need family companionship
  2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients.
Registry
clinicaltrials.gov
Start Date
April 22, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Xin Peng
Responsible Party
Sponsor Investigator
Principal Investigator

Xin Peng

Deputy chief nurse

Wuhan Union Hospital, China

Eligibility Criteria

Inclusion Criteria

  • Breast cancer patients who are pathologically or cytologically diagnosed as cancer
  • TNM clinical stage IV

Exclusion Criteria

  • Terminal cancer patients who are mentally ill or confused and refuse to participate in the survey

Outcomes

Primary Outcomes

Change from Baseline meatal state on GAD-7 at Week 48.

Time Frame: Baseline and Week 48

The GAD-7 is a validated, self-reported instrument assessing average mental state intensify over the past 24 hour period. Possible scores range from 0 to 21.Change = (Week 48 Score - Baseline Score)

Change from Baseline physical state on kps at Week 48.

Time Frame: Baseline and Week 48

The kps is a validated, self-reported instrument assessing physical state average intensify over the past 24 hour period. Possible scores range from 0 to 100.Change = (Week 48 Score - Baseline Score)

Study Sites (1)

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