- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05801796
Appraising Medical Trial Experiences of Ovarian Cancer Patients
March 24, 2023 updated by: Power Life Sciences Inc.
Analyzing Factors of Patient Involvement in Ovarian Cancer Clinical Trials
Historically, participation in clinical trials has been highly skewed towards specific demographic groups.
However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited.
This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested.
Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future ovarian cancer patients.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Ovarian cancer patients who are actively considering enrolling in a medical trial, but have not yet completed enrollment and randomization.
Description
Inclusion Criteria:
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Patient has been diagnosed with ovarian cancer
- Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.
Exclusion Criteria:
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
- Pregnant, breastfeeding or expecting to conceive within the projected duration of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient decides to enroll in clinical trial
Time Frame: 3 Months
|
3 Months
|
|
Patient remains in clinical trial to completion
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cho KR, Shih IeM. Ovarian cancer. Annu Rev Pathol. 2009;4:287-313. doi: 10.1146/annurev.pathol.4.110807.092246.
- Eisenhauer EA. Real-world evidence in the treatment of ovarian cancer. Ann Oncol. 2017 Nov 1;28(suppl_8):viii61-viii65. doi: 10.1093/annonc/mdx443.
- Previs RA, Secord AA. Ovarian Cancer: Clinical Trial Breakthroughs and Impact on Management. Obstet Gynecol Clin North Am. 2019 Mar;46(1):67-88. doi: 10.1016/j.ogc.2018.09.005.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2024
Primary Completion (Anticipated)
April 1, 2025
Study Completion (Anticipated)
April 1, 2026
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
March 24, 2023
First Posted (Actual)
April 6, 2023
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 89480700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.