Breast CancerNCT05545254
Health-promoting Lifestyle in a Genetic Counseling Clinic
An observational study of Breast Cancer and Genetic Testing, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Genetic Testing
- What is being tested?
- genetic testing
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2019to 4 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- diagnosed with psychiatric or intellectual impairment
- having a history of genetic testing previously
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-promoting Lifestyle of Breast Cancer Patients and Family Members in a Chinese Genetic Counseling Clinic: A Cross-sectional Study
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
Read the detailed description
Purpose: This study 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.
Method: This was a cross-sectional study. The participants in this study originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 patients conformed to the inclusion and exclusion criteria were screened and contact from November 2019 to March 2022. Participants agreed to participate were sent a questionnaire web-link to be invited to finish this survey. Two questionnaires were included in the link, one referring to the socio-economic information, the other referring to the health-promoting lifestyle. Chinese Health-promoting lifestyle profile-Ⅱ(HPLP-Ⅱ) was used to evaluate the health-promoting lifestyle.
- Conditions
- Breast Cancer, Genetic Testing
- Being tested
- genetic testing
- Keywords
- Health-promoting lifestyle, breast cancer, genetic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic testingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome was measured during one month after the genetic test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start13 Nov 2019
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenqi Lu, Fudan University
- Investigators
- Zhenqi Lu, Master, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545254
- Sponsor's protocol ID
- FNF201830
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-promoting Lifestyle of Breast Cancer Patients and Family Members in a Chinese Genetic Counseling Clinic: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05545254
- Acronym / sponsor ID
- FNF201830
- Conditions
- Breast Cancer, Genetic Testing
- Keywords
- Health-promoting lifestyle, breast cancer, genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Purpose: This study 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.
Method: This was a cross-sectional study. The participants in this study originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 patients conformed to the inclusion and exclusion criteria were screened and contact from November 2019 to March 2022. Participants agreed to participate were sent a questionnaire web-link to be invited to finish this survey. Two questionnaires were included in the link, one referring to the socio-economic information, the other referring to the health-promoting lifestyle. Chinese Health-promoting lifestyle profile-Ⅱ(HPLP-Ⅱ) was used to evaluate the health-promoting lifestyle.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients and their family members who have undertaken genetic testing | – | Genetic: genetic testingIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- diagnosed with psychiatric or intellectual impairment
- having a history of genetic testing previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic testingTwo 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. | Genetic | Breast cancer patients and their family members who have undertaken genetic testing |
Primary outcome
Chinese Health-promoting lifestyle profile-Ⅱ
Time frame: The primary outcome was measured during one month after the genetic test.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenqi Lu, Master principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Genetic Testing, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Health-promoting lifestyle profile-Ⅱ (time frame: The primary outcome was measured during one month after the genetic test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.