The Treatment Preferences of Women Diagnosed With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

The Treatment Preferences of Women Diagnosed With Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367260
• Other study ID #: Pro00080624
• Status: Completed
• Start date: October 19, 2017
• Est. completion date: January 4, 2019

Study information

• Verified date: June 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: January 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Does not read and understand English

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Other:
• Preference Elicitation
Survey of patient preferences for treatment

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline