The Effect of Appropriate Family Companionship on the Phy... | NCT06385665

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

NCT06385665

Sponsor

Xin Peng

Status

Unknown status

Last Update Posted

Apr 26, 2024Actual

Enrollment

304Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Graded companionship

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2024Estimated

Primary Completion Date

Apr 22, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 26, 2023

First Submission Date that Met QC Criteria

Apr 25, 2024

First Posted Date

Apr 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2024

Last Update Posted Date

Apr 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xin Peng, Deputy chief nurse, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

Xin PengOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Patients with advanced breast cancer need family companionship
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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

304Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
accompanying group	Experimental		Behavioral: Graded companionship
non-accompanied group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Graded companionship	Behavioral	Accompanying levels are divided into beginner, intermediate and advanced	accompanying group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xin Peng, Postgraduate	Contact	15071399933		200507365@qq.com

Overall Officials

Name	Affiliation	Role
Deyin Hu, PhD	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan		430022	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided