NCT05545254

Brief Summary

This was a cross-seThis was a cross-sectional study, which aimed to describe the health-promoting lifestyle of breast cancer patients and family members in a Chinese genetic counseling clinic, and to explore its various levels with different socio-economic variables. 259 patients conformed to the inclusion and exclusion criteria were enrolled. Participants were sent a questionnaire web-link to be invited to finish this survey. 140 participants were finally included in this study. Finally, a good level of health-promoting lifestyle of breast cancer patients and family members was acquired. More education and intervention should be tailored to enhance and encourage health-promoting lifestyle behaviors in participants with low monthly family income. Additionally, developing nutritional curriculum and strengthening the publicity of nutritional popular science were priorities in the future improvement measures.ctional study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

September 9, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

Health-promoting lifestyle, breast cancer, genetic

Outcome Measures

Primary Outcomes (1)

  • Chinese Health-promoting lifestyle profile-Ⅱ

    HPLP-Ⅱ is an scale instrument used to evaluate a person's health-promoting lifestyle behaviors, which contains 52 items and has been translated into Chinese in 1997.It contains 6 subscales: self-actualization, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. A Likert 4-scale is used to measure each item, and never to regularly signifies 1-4. The total score ranges from 52 to 208. Higher scores mean better health-promoting behaviors.

    The primary outcome was measured during one month after the genetic test.

Study Arms (1)

Breast cancer patients and their family members who have undertaken genetic testing

In this study, 259 participants were recruited from November 2019 to March 2022. All participants originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 participants were contact, and among them, 158 participants finally agreed to participate and completed the survey.

Genetic: genetic testing

Interventions

Two questionnaires were included in the link, one referring to the demographic information, and another one involving the health-promoting lifestyle. In the demographic information, the genetic test results were not requested to be written, but the participants need to answer whether they understand the results. The HPLP-Ⅱ is an scale instrument used to evaluate a person's health-promoting lifestyle behaviors, which contains 52 items and has been translated into Chinese in 1997. It contains 6 subscales: self-actualization, health responsibility, physical activity, nutrition, interpersonal relationships and stress management.

Breast cancer patients and their family members who have undertaken genetic testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this study, 259 participants were recruited from November 2019 to March 2022. All participants originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 participants were contact, and among them, 158 participants finally agreed to participate and completed the survey.

You may qualify if:

  • over 18 years old;
  • with a diagnosis of breast cancer or having a family history of breast cancer
  • the first time to take genetic testing in our clinic
  • ECOG\<2.

You may not qualify if:

  • diagnosed with psychiatric or intellectual impairment
  • having a history of genetic testing previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Zhenqi Lu, Master

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of nursing department

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 19, 2022

Study Start

November 13, 2019

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations