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CompletedNCT03367260Updated Jun 27, 2019

The Treatment Preferences of Women Diagnosed With Ovarian Cancer

An observational study in Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Carcinoma, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by Duke University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
18 Years to 89 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Ovarian Neoplasms by Duke University — none open to participants now, 1 under way, none of them phase 3. Ovarian Neoplasms · Duke University.

Started
2017
the only one that year
Observational
2 of 13
none open now
Registered
10th of 13
by date

Among the 13 studies in Ovarian Neoplasms by Duke University, this one is the only one that started in 2017, is one of 2 observational ones, and was the 10th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phase5 · 0 open
Observationalthis study2 · 0 open
Phase 12 · 0 open
Phase 1/22 · 0 open
Phase 21 · 0 open
Phase 41 · 0 open

By the year they started

First in 1992; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 30 across the 11 interventional studies, 81 across the 2 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.

Download CSVWith an account: the 13 studies in Ovarian Neoplasms by Duke University as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma

Keywords

  • patient preferences
04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Does not read and understand English
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Interventions

  • OtherPreference Elicitation

    Survey of patient preferences for treatment

06

What researchers measure

Primary outcomes

  1. Preference between two treatment alternatives as measured by discrete choice experiment (DCE).

    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).

    Time frame: baseline

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03367260
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Dec 8, 2017
Start date
Oct 19, 2017
Primary completion
Jan 4, 2019
Completion
Jan 4, 2019
Last update
Jun 27, 2019

Study contacts

Laura Havrilesky, MD
principal investigator · Duke University

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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