Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02082470|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Other: follow-up care Other: active surveillance Other: questionnaire administration||Not Applicable|
I. To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer|
|Study Start Date :||April 11, 2014|
|Actual Primary Completion Date :||September 26, 2017|
|Actual Study Completion Date :||September 26, 2017|
Active Comparator: Arm I (standard post-treatment)
Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.
Other: active surveillance
Undergo cancer surveillance
Other: questionnaire administration
Experimental: Arm II (survivorship care planning)
Participants complete survivorship care planning in close collaboration with treating oncologists.
Other: follow-up care
Undergo survivorship care planning
Other: questionnaire administration
- Percentage of attrition [ Time Frame: 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 [ Time Frame: 2 months ]Descriptive statistics will be presented for the total retention.
- Recruitment rates [ Time Frame: 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 [ Time Frame: 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.
- Infrastructure for a larger comparative intervention study [ Time Frame: 2 months ]The descriptive statistical estimates will be used for sample size determination for a larger subsequent study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082470
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Virginia Sun||City of Hope Medical Center|