Cervical Intraepithelial NeoplasiasNCT06695871
Research on the Application of Patient Navigation-based Management Model of Patients After LEEP
A study testing Patient navigation-based health management in people with Cervical Intraepithelial Neoplasias, run by Peking University People's Hospital at 1 site in China.
Trial summary
Cervical cancer poses a significant threat to women's health and is a crucial public health issue. Early detection and treatment of cervical lesions and standardized management have emerged as essential pillars in the Global Cervical Cancer Elimination. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasias
- What is being tested?
- Patient navigation-based health management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged between 25 and 50 years;
- LEEP will be conducted following clinical evaluation;
- No intention to conceive within the subsequent year;
- Proficiency in utilizing social media platforms, such as WeChat, is required;
- Patients must be capable of providing informed consent to participate in the study and willing to engage in long-term follow-up.
Who cannot join
- Individuals who are widowed, separated, or experiencing atypical sexual activity due to reasons related to their spouse.
- Presence of genital tract malformations.
- A history of neurological disorders, such as stroke or epilepsy, or a history of psychiatric conditions, such as depression.
- Patients with other significant illnesses that could impact the long-term follow-up of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Wenhui Ren, PhD, 86+18800124938, rwh0617@outlook.com
About this study
Official title: Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions
Cervical cancer poses a significant threat to women's health and is a crucial public health issue. Early detection and treatment of cervical lesions and standardized management have emerged as essential pillars in the Global Cervical Cancer Elimination. The loop electrosurgical excision procedure (LEEP) is widely employed as a preferred approach for the diagnosis and treatment of precancerous cervical lesions and early invasive cervical cancer. Patients with high-grade cervical lesions are more prone to experiencing sexual dysfunction and psychological disorders after LEEP, attributed to the unique surgical site, physiological alterations, and psychological stress during the postoperative recovery process, thereby adversely affecting their quality of life. Currently, there is a shortage of research evidence regarding targeted intervention measures and long-term effect evaluations for sexual function quality and quality of life after LEEP for cervical lesions. In recent years, the health management model based on patient navigation has evolved into a novel modality for facilitating comprehensive tumor prevention and control. However, its effect in managing cervical lesions has yet to be comprehensively assessed. Therefore, we will design a randomized controlled trial to evaluate the impact of a patient navigation-based health management model on quality of life and sexual function after LEEP in patients with cervical lesions.
- Conditions
- Cervical Intraepithelial Neoplasias
- Being tested
- Patient navigation-based health management
- Keywords
- Loop electrosurgical excision procedure, Patient navigation, Quality of life, Sexual function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigation-based health managementOther
A patient navigation-based health management model for individuals with cervical lesions post-LEEP procedure, encompassing healthcare consultation services, personalized health guidance, and routine follow-up assessments.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The routine clinical outpatient follow-up protocol was implemented, and a postoperative rehabilitation health manual was provided to patients the day following LEEP surgery. Outpatient evaluations were subsequently conducted at 1 month, 3 months, and 6 months post-surgery. |
| Intervention group | Experimental | A postoperative rehabilitation health manual was provided to patients the day following LEEP surgery. The nursing team, possessing over one year of clinical experience in gynecological nursing and psychological counseling, collaborated with clinicians to deliver health consultation services. They conducted in-person consultations lasting 10-15 minutes during routine outpatient follow-ups at 1, 3, and 6 months post-surgery. Patients were assessed based on the challenges encountered in postoperative rehabilitation and sexual life, and tailored guidance services were administered. Additionally, online counseling and guidance services were offered at 2, 4, or 5 months following surgery. Receives: Other: Patient navigation-based health management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.
Measured: six months after LEEP
Secondary outcomes (6)
Sexual function index
The Chinese version of the Female Sexual Function Index was used to evaluate the sexual function index at three time points: before LEEP, three months after LEEP, and six months after LEEP.
Measured: before LEEP, three months after LEEP, and six months after LEEP
Anxiety
Anxiety symptoms were assessed using the Self-Rating Anxiety Scale at three-time points: before LEEP, three months after LEEP, and six months after LEEP.
Measured: before LEEP, three months after LEEP, and six months after LEEP
Quality of Life
The quality of life was assessed using 36-Item Short Form Survey.
Measured: before LEEP and three months after LEEP
Depression
Depression symptoms were assessed using the Self-Rating Anxiety Scale at three time points: before LEEP, three months after LEEP, and six months after LEEP.
Measured: before LEEP, three months after LEEP, and six months after LEEP
Vaginal discharge
Patient-reported alterations in the volume, color, and odor of vaginal secretions.
Measured: three and six months after LEEP
Recurrence rates
The recurrence of cervical lesions at three and six months post-surgery was evaluated using high-risk HPV testing, cytology test, and histopathological examination.
Measured: three and six months after LEEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiasStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Wenhui, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695871
- Sponsor's protocol ID
- 2024PHB398-001
- Other IDs
- MBZX0102024007
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions
- ClinicalTrials.gov ID
- NCT06695871
- Acronym / sponsor ID
- 2024PHB398-001
- Conditions
- Cervical Intraepithelial Neoplasias
- Keywords
- Loop electrosurgical excision procedure, Patient navigation, Quality of life, Sexual function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Nov 2024 (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.
Cervical cancer poses a significant threat to women's health and is a crucial public health issue. Early detection and treatment of cervical lesions and standardized management have emerged as essential pillars in the Global Cervical Cancer Elimination. The loop electrosurgical excision procedure (LEEP) is widely employed as a preferred approach for the diagnosis and treatment of precancerous cervical lesions and early invasive cervical cancer. Patients with high-grade cervical lesions are more prone to experiencing sexual dysfunction and psychological disorders after LEEP, attributed to the unique surgical site, physiological alterations, and psychological stress during the postoperative recovery process, thereby adversely affecting their quality of life. Currently, there is a shortage of research evidence regarding targeted intervention measures and long-term effect evaluations for sexual function quality and quality of life after LEEP for cervical lesions. In recent years, the health management model based on patient navigation has evolved into a novel modality for facilitating comprehensive tumor prevention and control. However, its effect in managing cervical lesions has yet to be comprehensively assessed. Therefore, we will design a randomized controlled trial to evaluate the impact of a patient navigation-based health management model on quality of life and sexual function after LEEP in patients with cervical lesions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The routine clinical outpatient follow-up protocol was implemented, and a postoperative rehabilitation health manual was provided to patients the day following LEEP surgery. Outpatient evaluations were subsequently conducted at 1 month, 3 months, and 6 months post-surgery. |
| Intervention group | Experimental | Other: Patient navigation-based health managementA postoperative rehabilitation health manual was provided to patients the day following LEEP surgery. The nursing team, possessing over one year of clinical experience in gynecological nursing and psychological counseling, collaborated with clinicians to deliver health consultation services. They conducted in-person consultations lasting 10-15 minutes during routine outpatient follow-ups at 1, 3, and 6 months post-surgery. Patients were assessed based on the challenges encountered in postoperative rehabilitation and sexual life, and tailored guidance services were administered. Additionally, online counseling and guidance services were offered at 2, 4, or 5 months following surgery. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals aged between 25 and 50 years;
- LEEP will be conducted following clinical evaluation;
- No intention to conceive within the subsequent year;
- Proficiency in utilizing social media platforms, such as WeChat, is required;
- Patients must be capable of providing informed consent to participate in the study and willing to engage in long-term follow-up.
Key exclusion criteria (4 listed)
- Individuals who are widowed, separated, or experiencing atypical sexual activity due to reasons related to their spouse.
- Presence of genital tract malformations.
- A history of neurological disorders, such as stroke or epilepsy, or a history of psychiatric conditions, such as depression.
- Patients with other significant illnesses that could impact the long-term follow-up of the study.
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 |
|---|---|---|
| Patient navigation-based health managementA patient navigation-based health management model for individuals with cervical lesions post-LEEP procedure, encompassing healthcare consultation services, personalized health guidance, and routine follow-up assessments. | Other | Intervention group |
Primary outcome
Quality of Life
Time frame: six months after LEEP
The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.
6 secondary outcomes
Sexual function index
Time frame: before LEEP, three months after LEEP, and six months after LEEP
Anxiety
Time frame: before LEEP, three months after LEEP, and six months after LEEP
Quality of Life
Time frame: before LEEP and three months after LEEP
Depression
Time frame: before LEEP, three months after LEEP, and six months after LEEP
Vaginal discharge
Time frame: three and six months after LEEP
Recurrence rates
Time frame: three and six months after LEEP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient navigation-based health management in people with Cervical Intraepithelial Neoplasias, run by Peking University People's Hospital 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhui Ren, PhD (86+18800124938, rwh0617@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: six months after LEEP). 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 Nov 2024.