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Status unknownNCT03412344Updated Jan 26, 2018

Factors Influencing Cancer Patients Participation in Clinical Trials in China.

An observational study in Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-26.

Sponsored by Chinese Academy of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cancer

Keywords

  • clinical trial
  • patient
  • questionnaire
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Chinese patients with a diagnosis of cancer who have joined cancer clinical trial.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Not meeting all eligibility criteria
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Oncology patients' understanding and attitude of clinical trials towards cancer clinical research will be evaluated by questionnaire.

    Time frame: 1 year

  2. The actual experience of participants in a cancer clinical trial will be investigated by questionnaire.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
    Beijing, Beijing 100021, China
    Recruiting
07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT03412344
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Shi Yuankai (Professor of medical oncology Deputy Director National Cancer Center Vice President Cancer Hospital Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC), Chinese Academy of Medical Sciences) — Principal investigator
First posted
Jan 26, 2018
Start date
Jul 15, 2017
Primary completion
Aug 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jan 26, 2018

Study contacts

Shiyu Jiang, MD
Contact
309615685@qq.com
+86 13121700970
Yuankai Shi, PhD
principal investigator · Chinese Academy of Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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