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

NCT06385665 | Unknown

• 1 other identifier: Xin Peng
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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. 1.Patients with advanced breast cancer need family companionship
2. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Change from Baseline meatal state on GAD-7 at 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)

  Baseline and Week 48

• Change from Baseline physical state on kps at 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)

  Baseline and Week 48

Study Arms (2)

accompanying group

EXPERIMENTAL

Behavioral: Graded companionship

non-accompanied group

NO INTERVENTION

Interventions

Graded companionship BEHAVIORAL

Accompanying levels are divided into beginner, intermediate and advanced

accompanying group

Eligibility Criteria

• Age: 21 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xin Peng: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430022, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Deyin Hu, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xin Peng, Postgraduate

CONTACT

15071399933; 200507365@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief nurse

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: April 26, 2024
• Study Start: April 22, 2024
• Primary Completion: April 22, 2024
• Study Completion: December 31, 2024
• Last Updated: April 26, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)