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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer

Conditions
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Stage IB Ovarian Epithelial Cancer, Cancer Survivor, Stage IA 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

Intervention / Treatment
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* Other: follow-up care
* Other: active surveillance
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard post-treatment)<br>Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists. | Other: active surveillance<br>* Undergo cancer surveillance<br>Other: questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Arm II (survivorship care planning)<br>Participants complete survivorship care planning in close collaboration with treating oncologists. | Other: follow-up care<br>* Undergo survivorship care planning<br>Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of attrition | 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. | 2 months | 
| Total retention | Descriptive statistics will be presented for the total retention. | 2 months | 
| Recruitment rates | 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. | 2 months | 
| Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infrastructure for a larger comparative intervention study | The descriptive statistical estimates will be used for sample size determination for a larger subsequent study. | 2 months |