Couples-Based Mindfulness for Young Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale
研究概览
简要总结
This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. The intervention will be administered in your home by using recorded videos of a trained MBSR instructor. Before, during, and after the 8-week intervention, participants will be asked to complete surveys.
详细描述
Participants will be young breast cancer survivors (YBCS) and their partners. Young breast cancer survivors are those diagnosed at age 45 or younger. This study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. The interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. YBCS participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week mindfulness-based stress reduction course for individuals. At the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. Partners of the YBCS assigned to the couples condition will also be asked to watch the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 45 years old when diagnosed with breast cancer
- •Diagnosed with stage 0, I, II, III breast cancer
- •within 1 to 6 years after diagnosis of breast cancer
- •Married or unmarried and living together.
- •Living anywhere in the United States
- •Both members of the couple must understand, read, and speak English
- •Both members of the couple must have regular access to email and willingness to use the Internet.
排除标准
- •Neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former MBSR class.
研究组 & 干预措施
Couples MBSR
Young breast cancer survivors and their partners take part in an 8-week Couples Mindfulness-Based Stress reduction (C-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor and partner will be asked to watch a video module, together, each week for a total of 8 weeks. The C-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts.
Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention.
干预措施: Couples MBSR (Behavioral)
Individual MBSR
Young breast cancer survivors take part in an 8-week Individual Mindfulness-Based Stress reduction (I-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor will be asked to watch a video module each week for 8 weeks in a row. The I-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts.
Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention.
干预措施: Individual MBSR (Behavioral)
结局指标
主要结局
Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale
时间窗: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Change in couple functioning measured by the Sexual Interest and Satisfaction Scale
时间窗: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory
时间窗: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Perceived Partner Responsiveness
时间窗: Baseline to 8 weeks
This scale will be measured each week for the 8 weeks of the intervention
Change in couple functioning measured by the Interpersonal Mindfulness Scale
时间窗: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
次要结局
- Change in depression scores measured by the PROMIS -- Depression(Baseline to 6 months)
- Change in anxiety scores measured by PROMIS -- Anxiety(Baseline to 6 months)
- Change in fatigue scores measured by PROMIS -- Fatigue(Baseline to 6 months)
- Changes in salivary cortisol biomarker to assess stress levels(Baseline to 8 weeks)
- Changes in physical functioning measured by the PROMIS - Physical Function(Baseline to 6 months)
- Changes in trait mindfulness measured by Mindful Attention and Awareness Scale(Baseline to 6 months)
- Change in stress scores measured by the Perceived Stress Scale(Baseline to 6 months)
研究者
Ann Bettencourt
Dr. Ann Bettencourt
University of Missouri-Columbia