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| ID | Type | Description | Link |
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| R01CA285674 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.
The main questions it aims to answer are:
Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Care-as-Usual (Sexual Health Resources Alone) | Active Comparator | Participants will receive their usual care and a resource guide with information on sexual health and gynecologic cancer. The guide will include organizational resources and links to websites with information about sexual health and gynecologic cancer. |
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| Sexual Health Resources + Starting the Conversation Video/Workbook | Experimental | Participants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starting the Conversation | Behavioral | Starting the Conversation includes a 25-minute video with information about sexual health and gynecologic cancer and tips about how to talk to their cancer care team about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Communication - Raise Topic of Sexual Health | Number of patients who raise the topic of sexual health concerns in a clinic visit. | 2 weeks |
| Clinical Communication - Ask a Question about Sexual Health | Number of patients who ask a question about sexual health concerns in a clinic visit. | 2 weeks |
| Clinical Communication - Express a Concern about Sexual Health | Number of patients who express a sexual health concern in a clinic visit. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Sexual Function | Patients' self-reported sexual function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) SexFS Brief Profile Version 2.0. Four domains (lubrication, vaginal discomfort, satisfaction, and interest) will be scored. Domains are scored using T-scores, with higher scores signifying better sexual function for the lubrication, satisfaction, and interest domains. Lower scores in the vaginal discomfort range signify better sexual function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer B Reese, PhD | Contact | 215-214-3223 | jennifer.reese@fccc.edu | |
| Kristen A Sorice | Contact | 215-214-1433 | kristen.sorice@fccc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
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| Sexual Health Resources | Behavioral | The sexual health resource guide includes institutional resources for patients with sexual concerns (for example, the Women's Survivorship Clinic) and links to reputable websites with information about sexual health after gynecologic cancer. |
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| Baseline, 2 weeks, 3 months, 6 months |
| Self-Reported Sexual Activity | Patients' self-reported sexual activity will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Activity screener. Number of participants reporting any sexual activity will be reported. | Baseline, 2 weeks, 3 months, 6 months |
| Self-Reported Anxiety Symptoms | Patients' self-reported anxiety symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety. | Baseline, 2 weeks, 3 months, 6 months |
| Self-Reported Depressive Symptoms | Patients' self-reported depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depressive symptoms. | Baseline, 2 weeks, 3 months, 6 months |