CancerNCT03412344
Factors Influencing Cancer Patients Participation in Clinical Trials in China.
An observational study of Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and know about patients' attitude toward clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2017to Dec 2018
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Chinese patients with a diagnosis of cancer who have joined cancer clinical trial.
Who may be able to join
- Clinical diagnosis of malignancy
- Aged 18 years or older
- Ability to understand and complete the questionnaire independently or with the help of a relative or staff member of the oncology department
- Patients have been consented to join an oncology treatment clinical study and have begun active treatment of an oncology clinical trial
Who cannot join
- Not meeting all eligibility criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100021
Yuankai Kai, PhD, +86 10 87788293, cancergcp@163.com
About this study
Official title: Assessing Knowledge and Affecting Factors Associated With Cancer Patients Participation in Clinical Trials in China.
This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and know about patients' attitude toward clinical trials. The investigators aim to find ways to make cancer clinical trials in China more efficient and satisfied patients participating in clinical trials in China.
- Conditions
- Cancer
- Keywords
- clinical trial, patient, questionnaire
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient related factors and the doctor related factors that influence patient decision regarding participation in a cancer clinical trial will be explored by questionnaire.
Measured: 1 year
Secondary outcomes (2)
Oncology patients' understanding and attitude of clinical trials towards cancer clinical research will be evaluated by questionnaire.
Measured: 1 year
The actual experience of participants in a cancer clinical trial will be investigated by questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start15 Jul 2017
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yuankai, Chinese Academy of Medical Sciences
- Investigators
- Yuankai Shi, PhD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412344
- Sponsor's protocol ID
- CH-HUR-004
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang S, Liu P, Yang S, Yang J, Wu D, Fang H, Qin Y, Zhou S, Xu J, Sun Y, Mo H, Gui L, Xing P, Lan B, Zhang B, Tang L, Sun Y, Shi Y. Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China. BMJ Open. 2019 Jun 1;9(5):e028589. doi: 10.1136/bmjopen-2018-028589.
PubMed 31154312
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Knowledge and Affecting Factors Associated With Cancer Patients Participation in Clinical Trials in China.
- ClinicalTrials.gov ID
- NCT03412344
- Acronym / sponsor ID
- CH-HUR-004
- Conditions
- Cancer
- Keywords
- clinical trial, patient, questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jan 2018 (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 research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and know about patients' attitude toward clinical trials. The investigators aim to find ways to make cancer clinical trials in China more efficient and satisfied patients participating in clinical trials in China.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with a diagnosis of cancer who have joined cancer clinical trial.
Key inclusion criteria (4 listed)
- Clinical diagnosis of malignancy
- Aged 18 years or older
- Ability to understand and complete the questionnaire independently or with the help of a relative or staff member of the oncology department
- Patients have been consented to join an oncology treatment clinical study and have begun active treatment of an oncology clinical trial
Key exclusion criteria (1 listed)
- Not meeting all eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The patient related factors and the doctor related factors that influence patient decision regarding participation in a cancer clinical trial will be explored by questionnaire.
Time frame: 1 year
2 secondary outcomes
Oncology patients' understanding and attitude of clinical trials towards cancer clinical research will be evaluated by questionnaire.
Time frame: 1 year
The actual experience of participants in a cancer clinical trial will be investigated by questionnaire.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Derived from this study: PubMed 31154312Jiang S, Liu P, Yang S, Yang J, Wu D, Fang H, Qin Y, Zhou S, Xu J, Sun Y, Mo H, Gui L, Xing P, Lan B, Zhang B, Tang L, Sun Y, Shi Y. Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China. BMJ Open. 2019 Jun 1;9(5):e028589. doi: 10.1136/bmjopen-2018-028589.
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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.
Yuankai Shi, PhD principal investigator
Chinese Academy of Medical Sciences
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 Cancer, run by Chinese Academy of Medical Sciences 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 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 26 Jan 2018. 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 Shiyu Jiang, MD (+86 13121700970, 309615685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient related factors and the doctor related factors that influence patient decision regarding participation in a cancer clinical trial will be explored by questionnaire. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412344, which also lists 1 linked publication.
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 26 Jan 2018.