Multidimensional Burden of Platinum Resistant Ovarian Cancer (PROC) on Patients and Caregivers in Canada

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: Ovarian Cancer; Caregiver Burden; Patient Burden
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2Y 1V3
      • PROxy Network, an initiative of PeriPharm inc.

Participation Criteria

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

1. ≥18 years old
2. 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)
3. Ability to read and understand French or English
4. Signature of ICF

Patients Exclusion Criteria

1. Patients with PSOC, defined as those who:

   1. Have not progressed within less than 6 months after completion of platinum-based chemotherapy or;
   2. Are still on platinum chemotherapy or;
   3. Receive maintenance therapy.
2. 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:

1. ≥18 years old
2. 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.
3. Ability to read and understand French or English
4. Signature of ICF.

Caregivers Exclusion Criteria:

1. Caregivers of patients with PSOC (see definition above)
2. Caregivers of PROC patients who have passed away
3. Caregivers of platinum-refractory patients (see definition above)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with PROC part of Ovarian Cancer Canada mailing lists	Other: No intervention; No specific intervention is assess in this study.
Caregiver of PROC patients part of Ovarian Cancer Canada mailing lists	Other: No intervention; 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	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	Using the Measure of Ovarian Symptoms and Treatment (MOST-T24 (V2))	At recruitment
Caregiver's Quality of Life	Using the CareGiver Oncology Quality of Life (CarGOQoL) questionnaire	At recruitment
Patients and caregivers work productivity loss and activity impairment	Using the Work Productivity and Activity Impairment (WPAI) questionnaire	At recruitment
Patient's preference in treatment	Using a questionnaire specifically developed for this study based on a literature search, physician input and patient association input.	At recruitment

Collaborators and Investigators

• Sponsor: PeriPharm

Study record dates

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