Overview

This trial is active, not recruiting.

Conditions cancer survivor, stage ia ovarian epithelial cancer, stage ib ovarian epithelial cancer, stage ic ovarian epithelial cancer, stage iia ovarian epithelial cancer, stage iib ovarian epithelial cancer, stage iic ovarian epithelial cancer, stage iiia ovarian epithelial cancer, stage iiib ovarian epithelial cancer, stage iiic ovarian epithelial cancer
Treatments follow-up care, active surveillance, questionnaire administration
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date April 2014
End date February 2017
Trial size 14 participants
Trial identifier NCT02082470, 14001, NCI-2014-00423, P30CA033572

Summary

This pilot clinical trial studies survivorship care planning in supporting quality of life in ovarian cancer survivors following primary treatment. Survivorship care plans have the potential to empower patients and provide them with a plan of care following treatments. Survivorship care planning may support patient's overall well-being and quality of life after treatment of ovarian cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.
active surveillance
Undergo cancer surveillance
questionnaire administration
Ancillary studies
(Experimental)
Participants complete survivorship care planning in close collaboration with treating oncologists.
follow-up care
Undergo survivorship care planning
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Percentage of attrition
time frame: 2 months
Total retention
time frame: 2 months
Recruitment rates
time frame: 2 months
Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form
time frame: 2 months

Secondary Outcomes

Measure
Infrastructure for a larger comparative intervention study
time frame: 2 months

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Diagnosis of stage I, II, or III ovarian cancer - Ability to read or understand English - All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: - Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Additional Information

Official title Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer
Principal investigator Virginia Sun
Description PRIMARY OBJECTIVES: I. To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer. SECONDARY OBJECTIVES: I. To develop the infrastructure and strategy for a larger comparative intervention study (National Cancer Institute [NCI] R01). OUTLINE: Participants are assigned to 1 of 2 arms. ARM I: Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists. ARM II: Participants complete survivorship care planning in close collaboration with treating oncologists. After completion of study treatment, participants are followed up at 2 months.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.
Location data was received from the National Cancer Institute and was last updated in August 2016.