The Treatment Preferences of Women Diagnosed With Ovarian Cancer

NCT ID: NCT03367260

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-19
• Study Completion Date: 2019-01-04

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Preference Elicitation

Survey of patient preferences for treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer

Exclusion Criteria

• Does not read and understand English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Havrilesky, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00080624

Identifier Type: -

Identifier Source: org_study_id