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The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06385665
Enrollment
304
Registered
2024-04-26
Start date
2024-04-22
Completion date
2024-12-31
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

BEHAVIORALGraded companionship

Accompanying levels are divided into beginner, intermediate and advanced

Sponsors

Xin Peng
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 72 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline meatal state on GAD-7 at Week 48.Baseline and Week 48The 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.Baseline and Week 48The 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)

Countries

China

Contacts

Primary Contactxin Peng, Postgraduate
200507365@qq.com15071399933

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026