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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00467 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14359 | Other Identifier | City of Hope Medical Center |
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Feasibility issues
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.
PRIMARY OBJECTIVES:
I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?
OUTLINE:
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
After completion of study, patients are followed up at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (W2W program) | Experimental | Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Care | Procedure | Complete W2W mentoring program |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life benefits for patients, as assessed by the FACT-G | Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods. | Baseline to up to 12 months |
| Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey | Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. | Up to 12 months |
| Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey | Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. | Up to 12 months |
| Satisfaction of patients' family caregivers with the timing, content, and format of the program | Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thanh Dellinger, MD | 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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| Quality-of-Life Assessment | Other | Complete the FACT-G |
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| Questionnaire Administration | Other | Complete the W2W Patient Survey |
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| Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index |
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods. |
| Up to 12 months |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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