H.O.P.E: Helping Ovarian Cancer Patient… | Clinical Trial

Key information

Conditions

Platinum-resistant Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Palliative Care Recurrent Ovarian Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill, North Carolina, United States

About this study

Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer. All patient participants will complete two quality of life (QOL) questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter. Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks.

Patients will be assigned to two arms randomly: 1) usual care or 2) structured palliative care. The primary endpoint is quality of life. A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm. The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Platinum-resistant ovarian cancer or recurrent ovarian cancer
Ability to read and respond to questions in English

Exclusion criteria

Platinum-sensitive recurrent ovarian cancer without a significant clinical event
Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol

Treatment and study plan

Structured Palliative Care

Other

Structured palliative care approach, defined as the gynecologic oncology team performing comprehensive symptom assessment with the Quality Data Collection Tool Palliative Care (QDACT-PC) and providing interventions based on National Comprehensive Cancer Network (NCCN) guidelines. Symptom scores above the acceptable threshold in the QDACT-PC tool that occur after two consecutive visits will automatically trigger palliative care consultation.

Usual Care

Other

Usual care described as current practice by the gynecologic oncology team with referral to PC specialist at provider discretion or at the request of the patient or their families.

Primary outcomes

Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care)

Time frame: Every 12 weeks for a maximum of 5 years

A combined FACT-O and FACIT-PAL (version 4)16 will be administered at baseline and 12 week intervals on all subjects. The FACT Measurement System is a validated group of questions that measure health-related QOL in cancer patients. Both questionnaires have identical questions for physical well-being, functional well-being, emotional well-being, and social well-being. The additional subscales of the FACT-O and FACIT-PAL will be combined to provide a comprehensive quality of life assessment specific to ovarian cancer and palliative care.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Mar 18, 2014
Registry last updated: May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed