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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-02300 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro20160000637 | |||
| 131602 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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The study was never initiated, no patients were enrolled. It has been closed with the IRB.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.
PRIMARY OBJECTIVES:
I. To examine the feasibility and acceptability of an online coping and communication skills intervention (CCI).
II. To collect pilot data on the impact of online CCI on global and cancer-specific distress.
OUTLINE:
Patients complete 3 modules of online CCI intervention.
After completion of study, patients are followed up at 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (CCI intervention) | Experimental | Patients complete 3 modules of online CCI intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Receive CCI intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention | Will define feasibility/acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program. | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in psychological adaptation- Beck Depression Inventory (BDI) | Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63 | Baseline up to 2 months |
| Changes in psychological adaptation-Mental Health Inventory (MHI) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Manne | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Survey Administration | Other | Ancillary studies |
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Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used |
| Baseline up to 2 months |
| Changes in psychological coping | Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests. | Baseline up to 2 months |
| Examine acceptability of an online CCI | Will define acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program. | Up to 2 months |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D002577 | Uterine Cervical Diseases |
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