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

April 25, 2024 updated by: Xin Peng

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: xin Peng, Postgraduate
  • Phone Number: 15071399933
  • Email: 200507365@qq.com

Study Locations

  • China
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Peng Xin, postgraduate

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: accompanying group
Behavioral: Graded companionship
Accompanying levels are divided into beginner, intermediate and advanced
No Intervention: non-accompanied group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and Week 48
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)
Baseline and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xin Peng

Investigators

  • Principal Investigator: Deyin Hu, PhD, Wuhan Union Hospital, China

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)

April 22, 2024

Primary Completion (Estimated)

April 22, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xin Peng

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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