Brief Title
The Treatment Preferences of Women Diagnosed With Ovarian Cancer
Official Title
The Treatment Preferences of Women Diagnosed With Ovarian Cancer
Brief Summary
The primary objective of this study is to apply best-practice stated-preference methods to
quantify the extent to which women with ovarian cancer accept the risks, side effects, and
out-of-pocket costs associated with treatment in return for progression-free survival benefit
afforded by a treatment, regardless of whether there is an overall survival benefit.
Detailed Description
The investigators propose to perform a preferences survey to be administered to women with
ovarian cancer.The investigators anticipate that about 1/3 of the study cohort will include
patients who are receiving treatment with an oral ADP-ribose polymerase inhibitors (PARPi).
The investigators will begin by conducting interviews with 5 pilot subjects as they test the
preferences survey. Based on their feedback the survey may be updated for clarity. During the
final survey phase, subjects will be recruited and invited to participate in the choice
experiment by Biologics, Inc., a specialty pharmacy company that dispenses oral PARPis.
Subjects may also be recruited through ResearchMatch.org and at the Gynecologic Oncology
division at Duke. Up to 300 women may be included in this study, at least 100 women will have
received treatment with a PARPi.
Discrete choice experiment (DCE) questions generate limited dependent-variable,
cross-section/time-series data. The study team will use random-parameters logit (RPL) to
analyze the choice-format conjoint data collected in the DCE survey. Unobserved variation in
preferences across the sample can bias estimates in conventional conditional-logit choice
models. RPL avoids this potential bias by estimating a distribution of preferences around
each model parameter that accounts for variations among individual preferences not accounted
for by the variables in the model. The flexible correlation structure of RPL also accounts
for within-sample correlation in the question sequence for each respondent.
There are no physical risks to subject participation in this survey protocol.
Study Type
Observational
Primary Outcome
Preference between two treatment alternatives as measured by discrete choice experiment (DCE).
Condition
Ovarian Cancer
Intervention
Preference Elicitation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
115
Start Date
October 19, 2017
Completion Date
January 4, 2019
Primary Completion Date
January 4, 2019
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer
Exclusion Criteria:
- Does not read and understand English
Gender
Female
Ages
18 Years - 89 Years
Accepts Healthy Volunteers
No
Contacts
Laura Havrilesky, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03367260
Organization ID
Pro00080624
Responsible Party
Sponsor
Study Sponsor
Duke University
Study Sponsor
Laura Havrilesky, MD, Principal Investigator, Duke University
Verification Date
June 2019