The Treatment Preferences of Women Diagnosed With Ovarian Cancer

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03367260
Collaborator
(none)
115
1
14.5
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Preference Elicitation

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 Design

Study Type:
Observational
Actual Enrollment :
115 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Treatment Preferences of Women Diagnosed With Ovarian Cancer
Actual Study Start Date :
Oct 19, 2017
Actual Primary Completion Date :
Jan 4, 2019
Actual Study Completion Date :
Jan 4, 2019

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer
Exclusion Criteria:
  • Does not read and understand English

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Laura Havrilesky, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03367260
Other Study ID Numbers:
  • Pro00080624
First Posted:
Dec 8, 2017
Last Update Posted:
Jun 27, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2019