Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Negative affect as measured by the Affect Balance Scale- Negative Affect subscale
研究概览
简要总结
To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. Participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.
详细描述
This is a randomized controlled trial comparing the effects of 5-wk group-based stress management interventions (cognitive behavioral therapy [CBT] or relaxation training [RT]) vs a time-matched 5-wk group-based health education (HE) condition on psychosocial adaptation (negative and positive mood, social disruption) and physiological adaptation (cortisol and immune function) in women with non-metastatic breast cancer who are undergoing primary treatment. Participants are recruited in the weeks after surgery and before the start of adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological adaptation indicators, and are then randomly allocated to either CBT, RT or HE. They are re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up. Primary hypothesis is that women assigned to CBT or RT will show greater reductions in negative affect and social disruption, and greater increases in positive affect over time compared to women assigned to HE. Secondary hypothesis is that women assigned to CBT or RT will show greater decreases in cortisol and greater increases in immune functioning over time compared to those assigned to HE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy
排除标准
- •prior cancer, prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality), lack of fluency in English and had begun adjuvant therapy at time of first assessment
结局指标
主要结局
Negative affect as measured by the Affect Balance Scale- Negative Affect subscale
时间窗: Changes in scores from baseline to 12-month follow-up
Change from baseline to 12-month follow-up in the Affect Balance Scale- Negative Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Negative Affect subscale (i.e., depression, hostility, guilt, anxiety) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more negative affect. Possible scores range from 0-5.
Positive affect as measured by the Affect Balance Scale- Positive Affect subscale
时间窗: Changes in scores from baseline to 12-month follow-up
Change from baseline to 12-month follow-up in the Affect Balance Scale- Positive Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Positive Affect subscale (i.e., affection, contentment, vigor, joy) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more positive affect. Possible scores range from 0-5.
Social disruption as measure by the Sickness Impact Profile- Social Interaction subscale
时间窗: Changes in scores from baseline to 12-month follow-up
Change from baseline to 12-month follow-up in the Sickness Impact Profile- Social Interaction subscale, a 16-item subscale measuring the level of disruption in social activities. Respondents are asked statements regarding social disengagement as they specifically apply to their breast cancer (e.g., "I am doing fewer social activities with groups of people") over the past few weeks, and are asked to respond either No (0) or Yes (1), this applies to me. Scores are summed, with higher scores indicating greater social disruption. Possible scores range from 0-16.
次要结局
- Physiological Adaptation(12 month follow-up)
研究者
Michael H. Antoni
Professor
University of Miami