Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Emotional distress as measured by Profile of Mood States score
研究概览
简要总结
Baseline self-report outcome measures will be completed and additional assessments will occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months following completion of all sessions. Patients and therapists will complete the evaluation measures in private (at home, in an office).
At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and individual formats. The course of individual treatment varies and group treatment consists of 10 1.5-hour weekly sessions in the "intensive" phase, followed by 2 1.5-hour bi-weekly maintenance sessions. Individual treatment is one-on-one. In group treatment, there are typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to learn adaptive coping strategies and how to apply them to daily stressors. Additional content discusses use of seeking information, enhancing social support, enhancing body esteem and intimacy, and maintaining positive changes.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
- •Undergoing active treatment or in remission and undergoing active surveillance; age ≥21 and ≤80
- •Able to speak/read English.
排除标准
- •Concurrent diagnosis of organic brain syndrome, dementia, mental retardation
- •Non-English speaking, or significant sensory deficit
- •Major mental illness (e.g., schizophrenia, psychotic disorder).
研究组 & 干预措施
BBI Intervention
Biobehavioral Intervention
干预措施: BBI intervention (Behavioral)
结局指标
主要结局
Emotional distress as measured by Profile of Mood States score
时间窗: Up to 6 months following completion of treatment
Cancer specific traumatic stress as measured the by Impact of Events Scale score
时间窗: Up to 6 months following completion of treatment
Social support as measured by the Perceived Social Support from Family score
时间窗: Up to 6 months following completion of treatment
Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score
时间窗: Up to 6 months following completion of treatment
Dietary habits as measured by the Food Habits Questionnaire
时间窗: Up to 6 months following completion of treatment
Sexual functioning as measured by the Sexual Experience Scale score
时间窗: Up to 6 months following completion of treatment
Pain as measured by the Brief Pain Questionnaire score
时间窗: Up to 6 months following completion of treatment
Fatigue as measured by the Fatigue Severity Index score
时间窗: Up to 6 months following completion of treatment
Sleep as measured by the Pittsburg Sleep Quality Index
时间窗: Up to 6 months following completion of treatment
次要结局
- Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score(Up to 6 months following completion of treatment)
- Therapist-reported fidelity/Usage of BBI as measured through logs(Up to 6 months following completion of treatment)
研究者
Rachel Miller
Principal Investigator
University of Kentucky