NCT03367260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

November 20, 2017

Last Update Submit

June 26, 2019

Conditions

Keywords

patient preferences

Outcome Measures

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).

    baseline

Interventions

Survey of patient preferences for treatment

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Does not read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPatient Preference

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Laura Havrilesky, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 8, 2017

Study Start

October 19, 2017

Primary Completion

January 4, 2019

Study Completion

January 4, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations