Sexual and Reproductive HealthNCT05817981
The Investigation of Knowledge and Educational Demand of Sexual and Reproductive Health Among Cancer Survivors
An observational study of Sexual and Reproductive Health, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to explore the current situation and needs of adolescent and young adult cancer survivors for cancer-related reproductive health and fertility information. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 15 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual and Reproductive Health
- What is being tested?
- Semi-structured interview and Questionnaires set
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- May 2023to Mar 2024
- 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 15 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The NCCS defined someone as a cancer survivor from the moment of diagnosis through to the end of life.
Who may be able to join
- Adolescent and young adult cancer survivors: ①be aged range from 15 to 39, ②have been diagnosed with cancer and completed cancer treatment for at least 6 months, ③be able to read, understand and communicate in Chinese.
- Clinical oncology medical staff: ①are clinician or nurse specialist in oncology, ②the average daily contact time with patients in clinical work is not less than 20% of the clinical working time.
Who cannot join
- Adolescent and young adult cancer survivors: ①unable to complete communication due to serious mental or physical illness such as deaf-mute, mental illness resulting in unclear consciousness, ②be cancer recurrence or second cancer at screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Xia, PhD, +8618823359471, xiaw23@mail.sysu.edu.cn
About this study
Official title: The Investigation of Knowledge, Attitude/Belief, Practice (KAP) and Educational Demand Analysis of Sexual and Reproductive Health Among Adolescent and Young Adult Cancer Survivors in the Context of Healthy China
The goal of this observational study is to explore the current situation and needs of adolescent and young adult cancer survivors for cancer-related reproductive health and fertility information. The main questions it aims to answer are:
- What is the status of sexual and reproductive health knowledge among adolescent and young adult cancer survivors?
- What is the difference between the educational currently available and needs of cancer survivors? Part of the participants will be interviewed and then others will fill out questionnaires.
Read the detailed description
Cancer is a major public health problem worldwide. With the development of medical and diagnostic technology, the number of cancer survivors worldwide continues to grow, especially among adolescents and young adults. The global average cure rate for pediatric cancer patients was 52%, and the 5-year survival rates of this population in developed countries were about 80% in recent years. With this trend, more pediatric cancer patients are transitioning into the ranks of adolescent cancer survivors.
The fertility intention is generally strong among adolescent and young adult cancer survivors, more than three quarters of non-fertile cancer survivors have a high desire to have children. However, most of them have an unfulfilled desire to have their own child, which lead to high levels of fertility anxiety. What's more, studies have shown that adolescent and young adult cancer survivors also have a great need for sexual and reproductive health, but relevant forms of health care are rarely existed. Young and adolescent cancer survivors are limited by the age of illness and generally lack regular sexual and reproductive health education in schools. Due to the long and painful cancer treatments, they also have difficulty in obtaining relevant knowledge or reproductive health education from professionals such as doctors or nurses during cancer treatment. The lack of communication between providers of survival care services and between providers and survivors makes the sexual and reproductive health education much more difficult for cancer survivors. Numerous studies have shown that a lack of knowledge about reproductive health leads to increased psychological burden, low quality of life and depression among young cancer survivors. Thus, it is critical to meet the reproductive health literacy needs of young people and adolescent cancer survivors.
China is in the midst of an era of optimized birth and three-child policy, but the fertility policy for cancer survivors is relatively poor. Survival care in China currently focuses on the monitoring, prevention and treatment of delayed physical and mental reactions caused by cancer itself and its treatment in adolescent and young adult cancer survivors. Health promotion, such as sexual and reproductive health, or quality of life for survivors is rarely discussed. To some extent, high-quality, multichannel reproductive health counseling and health education may alleviate fertility concerns for adolescent and young adult cancer survivors and improve long-term quality of life. Therefore, on the basis of continuing to provide long-term care for adolescent and young adult cancer survivors, it is necessary to increase sexual and reproductive health counseling, health education and other services for this population. What's more, providing sexual and reproductive health related knowledge through multiple channels can improve the long-term quality of life for adolescents and adolescents.
Before applying interventions to help adolescent and young adult cancer survivors to access to cancer-related reproductive health information, a study exploring their intention to acquire knowledge and relevant factors must be implemented.
- Conditions
- Sexual and Reproductive Health
- Being tested
- Semi-structured interview, Questionnaires set
- Keywords
- sexual and reproductive health, adolescent and young adult, knowledge,attitude/belief,practice, educational demand
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
Before the questionnaire survey, 30 cancer survivors and 30 clinical oncology medical staff will respectively participate in different semi-structured interview individually.
Questionnaires setOther
Except for participants who participated in semi-structured interviews, other cancer survivors who met the inclusion criteria will be asked to respond to the demographic information sheet, the cancer related sexual and reproductive health knowledge and attitudes questionnaire, and the access methods and demand for cancer-related fertility information.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent and Young Adult Cancer Survivors | Adolescent and young adult cancer survivors who aged range from 15 to 39, having been diagnosed with cancer and completed cancer treatment for at least 6 months. Receives: Other: Semi-structured interview; Other: Questionnaires set | |
| Clinical oncology medical staff | Medical staff who routinely work in the oncology ward. Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and attitudes about sexual and reproductive health related to cancer
According to the qualitative research results and literature review, the questionnaire items can be tentatively prepared to cover the impact of cancer itself and the impact of treatment methods (such as surgery, radiotherapy, chemotherapy, hormone therapy, etc.) on reproductive function, the survivors' own reproductive function impairment, pregnancy risk, pregnancy risk, etc. Using the Likert level 5 scoring method, based on the level of the answer of each item,1 point means "completely unclear" and 5 points means "very clear".
Measured: Baseline
Secondary outcomes (2)
Socio-demographic information
The socio-demographic data collected through the structural questionnaire includes gender, age, family income, personal education level, marital status, fertility status, parents' education level, family income; cancer type, diagnosis time, completed treatment, medication, treatment completion time and completion degree.
Measured: Baseline
Access methods and demand for cancer-related fertility information
Referring to the questionnaire designed by B. Elizabeth Oosterhuis's research team, combined with the qualitative research results and China's national conditions, we have preliminarily formulated six options: oncologists, responsible nurses, doctors specializing in reproductive medicine, information materials distributed by hospitals, conversations with other cancer patients and through the website/Internet.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual and Reproductive HealthStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817981
- Sponsor's protocol ID
- pdjh2023 b0020
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Knowledge, Attitude/Belief, Practice (KAP) and Educational Demand Analysis of Sexual and Reproductive Health Among Adolescent and Young Adult Cancer Survivors in the Context of Healthy China
- ClinicalTrials.gov ID
- NCT05817981
- Acronym / sponsor ID
- pdjh2023 b0020
- Conditions
- Sexual and Reproductive Health
- Keywords
- sexual and reproductive health, adolescent and young adult, knowledge,attitude/belief,practice, educational demand
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 18 Apr 2023 (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.
The goal of this observational study is to explore the current situation and needs of adolescent and young adult cancer survivors for cancer-related reproductive health and fertility information. The main questions it aims to answer are:
- What is the status of sexual and reproductive health knowledge among adolescent and young adult cancer survivors?
- What is the difference between the educational currently available and needs of cancer survivors? Part of the participants will be interviewed and then others will fill out questionnaires.
Detailed description
Cancer is a major public health problem worldwide. With the development of medical and diagnostic technology, the number of cancer survivors worldwide continues to grow, especially among adolescents and young adults. The global average cure rate for pediatric cancer patients was 52%, and the 5-year survival rates of this population in developed countries were about 80% in recent years. With this trend, more pediatric cancer patients are transitioning into the ranks of adolescent cancer survivors.
The fertility intention is generally strong among adolescent and young adult cancer survivors, more than three quarters of non-fertile cancer survivors have a high desire to have children. However, most of them have an unfulfilled desire to have their own child, which lead to high levels of fertility anxiety. What's more, studies have shown that adolescent and young adult cancer survivors also have a great need for sexual and reproductive health, but relevant forms of health care are rarely existed. Young and adolescent cancer survivors are limited by the age of illness and generally lack regular sexual and reproductive health education in schools. Due to the long and painful cancer treatments, they also have difficulty in obtaining relevant knowledge or reproductive health education from professionals such as doctors or nurses during cancer treatment. The lack of communication between providers of survival care services and between providers and survivors makes the sexual and reproductive health education much more difficult for cancer survivors. Numerous studies have shown that a lack of knowledge about reproductive health leads to increased psychological burden, low quality of life and depression among young cancer survivors. Thus, it is critical to meet the reproductive health literacy needs of young people and adolescent cancer survivors.
China is in the midst of an era of optimized birth and three-child policy, but the fertility policy for cancer survivors is relatively poor. Survival care in China currently focuses on the monitoring, prevention and treatment of delayed physical and mental reactions caused by cancer itself and its treatment in adolescent and young adult cancer survivors. Health promotion, such as sexual and reproductive health, or quality of life for survivors is rarely discussed. To some extent, high-quality, multichannel reproductive health counseling and health education may alleviate fertility concerns for adolescent and young adult cancer survivors and improve long-term quality of life. Therefore, on the basis of continuing to provide long-term care for adolescent and young adult cancer survivors, it is necessary to increase sexual and reproductive health counseling, health education and other services for this population. What's more, providing sexual and reproductive health related knowledge through multiple channels can improve the long-term quality of life for adolescents and adolescents.
Before applying interventions to help adolescent and young adult cancer survivors to access to cancer-related reproductive health information, a study exploring their intention to acquire knowledge and relevant factors must be implemented.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent and Young Adult Cancer Survivors | – | Other: Semi-structured interview, Other: Questionnaires setAdolescent and young adult cancer survivors who aged range from 15 to 39, having been diagnosed with cancer and completed cancer treatment for at least 6 months. |
| Clinical oncology medical staff | – | Other: Semi-structured interviewMedical staff who routinely work in the oncology ward. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The NCCS defined someone as a cancer survivor from the moment of diagnosis through to the end of life.
Key inclusion criteria (2 listed)
- Adolescent and young adult cancer survivors: ①be aged range from 15 to 39, ②have been diagnosed with cancer and completed cancer treatment for at least 6 months, ③be able to read, understand and communicate in Chinese.
- Clinical oncology medical staff: ①are clinician or nurse specialist in oncology, ②the average daily contact time with patients in clinical work is not less than 20% of the clinical working time.
Key exclusion criteria (1 listed)
- Adolescent and young adult cancer survivors: ①unable to complete communication due to serious mental or physical illness such as deaf-mute, mental illness resulting in unclear consciousness, ②be cancer recurrence or second cancer at screening.
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 |
|---|---|---|
| Semi-structured interviewBefore the questionnaire survey, 30 cancer survivors and 30 clinical oncology medical staff will respectively participate in different semi-structured interview individually. | Other | Adolescent and Young Adult Cancer Survivors, Clinical oncology medical staff |
| Questionnaires setExcept for participants who participated in semi-structured interviews, other cancer survivors who met the inclusion criteria will be asked to respond to the demographic information sheet, the cancer related sexual and reproductive health knowledge and attitudes questionnaire, and the access methods and demand for cancer-related fertility information. | Other | Adolescent and Young Adult Cancer Survivors |
Primary outcome
Knowledge and attitudes about sexual and reproductive health related to cancer
Time frame: Baseline
According to the qualitative research results and literature review, the questionnaire items can be tentatively prepared to cover the impact of cancer itself and the impact of treatment methods (such as surgery, radiotherapy, chemotherapy, hormone therapy, etc.) on reproductive function, the survivors' own reproductive function impairment, pregnancy risk, pregnancy risk, etc. Using the Likert level 5 scoring method, based on the level of the answer of each item,1 point means "completely unclear" and 5 points means "very clear".
2 secondary outcomes
Socio-demographic information
Time frame: Baseline
Access methods and demand for cancer-related fertility information
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
Wei Xia principal investigator
Sun Yat-sen 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 Sexual and Reproductive Health, run by Sun Yat-sen 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and attitudes about sexual and reproductive health related to cancer (time frame: Baseline). 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 18 Apr 2023.