Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Depressive symptoms "change" is being assessed
研究概览
简要总结
This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.
详细描述
Primary goals of this project are:
Objective 1: Phase 1: To collect feedback from patients on CCI online and to assess patient's evaluation of CCI online.
Objective 2: Phase 1: To examine the feasibility and acceptability of a CCI online.
Objective 3: Phase 1/2: To collect preliminary data on changes in distress and coping associated with participation in CCI online.
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
- •Diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer or experienced a recurrence in the past 5 years;
- •Diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer or experienced a recurrence in the past 5 years;
- •Diagnosed with Stage 2 or higher cervical cancer or experienced a recurrence within the past 5 years;
- •Diagnosed with any stage Uterine Cancer (both Sarcoma and carcinosarcoma) or experienced a recurrence in the past 5 years;
- •At the time of recruitment the patient has received chemotherapy or radiation in the past 5 years, or is less than 5 years 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;
- •18 years of age or older;
- •English speaking;
- •Has internet access, able to view the online intervention sessions and attend telephone or video/telehealth chats to discuss the session content and provide feedback;
- •Must give informed consent within 5 years of diagnosis.
排除标准
- 未提供
结局指标
主要结局
Depressive symptoms "change" is being assessed
时间窗: Baseline, two and 6 months post-baseline
Depressive symptoms will be measures with the Beck Depression inventory which is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions. Calculate score bye summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Psychological distress and well being "change" is being assessed
时间窗: Baseline, two and 6 months post-baseline
The MHI-18 has subscales for Psychological Distress (anxiety, depression and loss of behavioral and emotional control) and Well-being. can assess 4 subscales of emotional status like Anxiety, Depression, Behavioral control, and Positive affect. MHI generates one total score. The subscale and total scores range from 0 - 100, with higher scores indicate better mental health
Cancer specific distress "change" is being assessed over the time points
时间窗: Baseline, two and 6 months post-baseline
The Impact of Events Scale (IES) (108) is a 21-item self-report measure focusing on intrusive and avoidant ideation related to ovarian cancer and its treatment. Using a 4-point Likert scale, participants rate how true each statement has been for them during the past week (scale range = 0-75).
Quality of life using the Fact-G "change" is being assessed
时间窗: Baseline, two and 6 months post-baseline
The Functional Assessment of Cancer Therapy - General (FACT-G) (110) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical (PWB), functional (FWB), social/family (SFWB), and emotional (EWB). PWB assesses the physical symptoms; FWB assesses the degree to which the person can participate and enjoy normal daily activities; SFWB assesses social support and communication, and EWB measures mood and emotional response to illness. The domains are summed
次要结局
- Physical impairment(Baseline, two and 6 months post-baseline)
- Positive emotional expression(Baseline, two and 6 months post-baseline)
- Coping "change" is being assessed(Baseline, two and 6 months post-baseline)
- Psychological flexibility(Baseline, two and 6 months post-baseline)
- Hope(Baseline, two and 6 months post-baseline)
- Emotional Acceptance scale Change(Baseline, two and 6 months post-baseline)
- Unsupportive responses from friends and family(Baseline, two and 6 months post-baseline)
- Holding back from sharing concerns(Baseline, two and 6 months post-baseline)
研究者
Sharon Manne, PhD
Chief, Behavioral Sciences
Rutgers, The State University of New Jersey