Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention
时间窗: Up to 2 months
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.
次要结局
- Changes in psychological adaptation- Beck Depression Inventory (BDI)(Baseline up to 2 months)
- Examine acceptability of an online CCI(Up to 2 months)
- Changes in psychological adaptation-Mental Health Inventory (MHI)(Baseline up to 2 months)
- Changes in psychological coping(Baseline up to 2 months)
研究者
Sharon Manne, PhD
Professor of Medicine
Rutgers Cancer Institute of New Jersey