Endometrial Carcinoma Clinical Trial
Official title:
Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
| Verified date | April 2021 |
| Source | Rutgers, The State University of New Jersey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 31, 2020 |
| Est. primary completion date | May 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months - Newly diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer in the past 6 months - Newly diagnosed with stage 2 or higher cervical cancer within the past 6 months - Newly diagnosed with any stage uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months - At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery - At the time of recruitment, a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1 - English speaking - Has internet access - Must give informed consent within 6 months of diagnosis |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Rutgers, The State University of New Jersey | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Changes in psychological adaptation-Mental Health Inventory (MHI) | Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used | Baseline up to 2 months | |
| Secondary | 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 | |
| Secondary | 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 |
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