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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00423 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14001 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard post-treatment) | Active Comparator | Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists. |
|
| Arm II (survivorship care planning) | Experimental | Participants complete survivorship care planning in close collaboration with treating oncologists. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| follow-up care | Other | Undergo survivorship care planning |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| active surveillance |
| Other |
Undergo cancer surveillance |
|
| questionnaire administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000359 | Aftercare |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
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