Psychological Interventions for Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 17
- 主要终点
- Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation
研究概览
简要总结
Subjects that have received medical treatment for ovarian cancer can be both physically and emotionally demanding for patients. The purpose of this study is to determine whether two common pyschological interventions (Communication Skills Intervention and Supportive Counseling) may improve the well-being of ovarian cancer patients compared to usual care.
详细描述
Very little is known in the psycho-oncology literature about why psychological interventions are effective or for how long these interventions exert an impact. Given many cancer patients experience recurrence and/or progression, it is important to know whether our relatively brief interventions facilitate how patients cope with this most-feared medical event. From a theoretical perspective, the study will advance our understanding of the mechanisms for change for two common treatment approaches, supportive and cognitive behavioral therapies.
Subjects will be enrolled and upon completion of a baseline survey, randomized to into one of three arms - Communication Skills Intervention, Supportive Counseling, and Usual Care. Subjects will complete surveys during the course of the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 是
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 withing the past 6 months
- •Newly diagnosed with any stage of 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) score of 0 or 1
- •English speaking
- •Lives within a two-hour commuting distance from the recruitment site
- •No hearing impairment
- •Has signed consent within 6 months of diagnosis date
排除标准
- 未提供
研究组 & 干预措施
Coping & Communication Skills
The CCI intervention focuses on bolstering stress management and problem solving abilities, identifying and expressing support needs constructively, facilitating the ability to cope with unchangeable issues, cognitive restructuring, and dealing effectively with body image and sexuality issues over seven weekly 60 minute sessions.
干预措施: Psychotherapy (Behavioral)
Supportive Counseling (SC)
The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions
干预措施: Psychotherapy (Behavioral)
Usual Care (UC)
Patients receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).
结局指标
主要结局
Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation
时间窗: 7 years
Global Psychological distress: Depressive symptoms - The BDI is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions.The MHI-18 has subscales for Psychological Distress and Well-being.
Do the two psychological interventions, CCI and SC, result in greater improvements in cancer-specific psychological adaptation
时间窗: 7 years
Cancer-Specific Distress: Traumatic Stress. The Impact of Events Scale (IES) is a 15-item self-report measure focusing on intrusive and avoidant ideation related to gynecologic cancer and its treatment. Using a 4-point Likert scale, participants rated how true each statement has been for them during the past week (scale range = 0-75). Fear of Recurrence/Progression. The Concerns about Recurrence Scale (CARS) is a 26 item assessment of the nature of women's fears about cancer recurrence.
Do the two psychological interventions, CCI and SC, result in greater improvements in quality of life
时间窗: 7 years
Quality of Life-General. The Functional Assessment of Cancer Therapy - General (FACT-G) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical, functional, social/family, and emotional. Spiritual well-being. The FACIT Spiritual well-being scale assesses a sense of meaning in life, harmony, peacefulness, sense of strength, and comfort from one's faith. The 12 item scale has two factors: Meaning/Peace and Faith.
次要结局
未报告次要终点