Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer

Not Applicable

Completed

• Conditions: Cancer Survivor; Stage IIA Ovarian Epithelial Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IB Ovarian Epithelial Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIB Ovarian Epithelial Cancer; Stage IIC Ovarian Epithelial Cancer; Stage IA Ovarian Epithelial Cancer; Stage IC Ovarian Epithelial Cancer; Stage IIIC Ovarian Epithelial Cancer
• Interventions: Other: active surveillance; Other: follow-up care; Other: questionnaire administration

• Registration Number: NCT02082470
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Study Start: 2014-04-11
• Status Verified: 2017-09
• Primary Completion: 2017-09-26
• Study Completion: 2017-09-26
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (standard post-treatment)	active surveillance	Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.
Arm II (survivorship care planning)	questionnaire administration	Participants complete survivorship care planning in close collaboration with treating oncologists.
Arm II (survivorship care planning)	follow-up care	Participants complete survivorship care planning in close collaboration with treating oncologists.
Arm I (standard post-treatment)	questionnaire administration	Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.

Primary Outcome Measures

Name	Time	Method
Recruitment rates	2 months	Important information regarding recruitment for the subsequent larger trial will be provided including estimates of the number of contacts needed to produce a qualified participant, the percentage of those who are qualified and agree to participate, and a retention rate.
Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form	2 months	Quantitative and qualitative descriptive statistics will be analyzed using descriptive statistics and content analysis methods to determine satisfaction with the timing, content, and delivery of the intervention.
Percentage of attrition	2 months	Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate. Descriptive statistics will also be presented for percentage of attrition (based on number of patients who failed to complete the 2 months study. Reasons for attrition will also be documented.
Total retention	2 months	Descriptive statistics will be presented for the total retention.

Secondary Outcome Measures

Name	Time	Method
Infrastructure for a larger comparative intervention study	2 months	The descriptive statistical estimates will be used for sample size determination for a larger subsequent study.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States