The Treatment Preferences of Women Diagnosed With Ovarian Cancer

June 26, 2019 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

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 to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A maximum on 300 subjects will be enrolled on this study. All subjects will have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer and at least 100 of them will have been treated with a PARPi.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Does not read and understand English

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
Measure Description
Time Frame
Preference between two treatment alternatives as measured by discrete choice experiment (DCE).
Time Frame: baseline
In the DCE, women are asked to choose between two hypothetical treatment scenarios characterized using 7 attributes (treatment schedule, out of pocket cost, peripheral neuropathy, nausea and vomiting, fatigue, progression-free survival and overall survival).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Laura Havrilesky, MD, Duke University

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 (Actual)

October 19, 2017

Primary Completion (Actual)

January 4, 2019

Study Completion (Actual)

January 4, 2019

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00080624

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.

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