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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Xiao Wang, Master contact

15611062210

WangX0420@163.com

China1 site
  • Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Wei Xia, PhD, +8618823359471, xiaw23@mail.sysu.edu.cn

Other trials in China

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:

  1. What is the status of sexual and reproductive health knowledge among adolescent and young adult cancer survivors?
  2. 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.

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 groups in NCT05817981
Study groupRoleWhat they receive
Adolescent and Young Adult Cancer SurvivorsAdolescent 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 staffMedical 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted18 Apr 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

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)
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

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.

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