- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07035067
- Original Trial
Multidimensional Burden of Platinum Resistant Ovarian Cancer (PROC) on Patients and Caregivers in Canada
April 1, 2026 updated by: PeriPharm
Filling the gap in Canadian evidence on the burden of PROC on QoL is essential.
It will help better understand the impact of PROC on multiple aspects of the lives of patients and their caregivers and the real-life hurdles faced by PROC patients and their caregivers.
The outputs of this study will help better understand the hurdles and challenges they face and the significant unmet medical need.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
24
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
-
-
Quebec
-
Montreal, Quebec, Canada, H2Y 1V3
- PROxy Network, an initiative of PeriPharm Inc.
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with ovarian cancer and caregivers of patients with ovarian cancer who are part Ovarian Cancer Canada mailing list.
Description
Patient Inclusion Criteria
- ≥18 years old
- Patients with PROC who received >1 prior line of therapy identified through a screening survey. PROC will be defined as recurrence less than 6 months after last platinum chemotherapy (i.e. carboplatin or cisplatin)
- Ability to read and understand French or English
- Signature of ICF
Patients Exclusion Criteria
Patients with PSOC, defined as those who:
- Have not progressed within less than 6 months after completion of platinum-based chemotherapy or;
- Are still on platinum chemotherapy or;
- Receive maintenance therapy.
- Patients with platinum-refractory ovarian cancer, defined as not responding or disease progressing during therapy or within three months after the last dose
Caregivers Inclusion Criteria:
- ≥18 years old
- Current caregiver of a patient with PROC (see definition to be used above) who received >1 prior line of therapy identified through a screening survey.
- Ability to read and understand French or English
- Signature of ICF.
Caregivers Exclusion Criteria:
- Caregivers of patients with PSOC (see definition above)
- Caregivers of PROC patients who have passed away
- Caregivers of platinum-refractory patients (see definition above)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with PROC part of Ovarian Cancer Canada mailing lists
|
No specific intervention is assess in this study.
|
|
Caregiver of PROC patients part of Ovarian Cancer Canada mailing lists
|
No specific intervention is assess in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To estimate the quality of life of patient with ovarian cancer
Time Frame: At recruitment
|
Using the the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) and EuroQol 5-dimendion 5-level (EQ-5D-5L)
|
At recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's symptoms assessment
Time Frame: At recruitment
|
Using the Measure of Ovarian Symptoms and Treatment (MOST-T24 (V2))
|
At recruitment
|
|
Caregiver's Quality of Life
Time Frame: At recruitment
|
Using the CareGiver Oncology Quality of Life (CarGOQoL) questionnaire
|
At recruitment
|
|
Patients and caregivers work productivity loss and activity impairment
Time Frame: At recruitment
|
Using the Work Productivity and Activity Impairment (WPAI) questionnaire
|
At recruitment
|
|
Patient's preference in treatment
Time Frame: At recruitment
|
Using a questionnaire specifically developed for this study based on a literature search, physician input and patient association input.
|
At recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 15, 2025
Primary Completion (Actual)
April 1, 2026
Study Completion (Actual)
April 1, 2026
Study Registration Dates
First Submitted
June 4, 2025
First Submitted That Met QC Criteria
June 16, 2025
First Posted (Actual)
June 24, 2025
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Behavioral Symptoms
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Stress, Psychological
- Behavior
- Caregiver Burden
- Ovarian Neoplasms
Other Study ID Numbers
- Ovarian Cancer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.