Promoting Resilience in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Feasibility of PRISM
研究概览
简要总结
The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.
详细描述
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer
排除标准
- •patients who do not speak English
研究组 & 干预措施
PRISM Intervention
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
干预措施: Promoting Resilience in Stress Management Intervention (Behavioral)
结局指标
主要结局
Feasibility of PRISM
时间窗: 8 months 4 weeks
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
次要结局
- Acceptable, Appropriate, and Feasible(post-PRISM (ranged from 1 to 7 months after baseline))
- Resilience(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Overall Post-Traumatic Growth Inventory(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Post-Traumatic Growth Inventory: Personal Strength Sub-scale(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Post-Traumatic Growth Inventory: New Possibilities Sub-scale(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Post-Traumatic Growth Inventory: Improved Relationships Sub-scale(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Functional Assessment of Chronic Illness Therapy Spiritual Well-Being(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Tumor Necrosis Factor Alpha(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Patient Activation Measure(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Fear of Cancer Recurrence Inventory(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Patient Health Questionnaire(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- General Anxiety Disorder Anxiety Scale(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Patient-Reported Outcomes Measurement Information System Global Health: Physical Health(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Patient-Reported Outcomes Measurement Information System Global Health: Mental Health(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Cholesterol(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Triglycerides(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- High Density Lipoprotein(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Low Density Lipoprotein(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Urea(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Albumin(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Creatinine(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Serum Cortisol(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Homocysteine(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- HbA1c(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- C-Reactive Protein(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Interleukin-6(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Allostatic Load(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
- Nail Cortisol(pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline))
研究者
Gabrielle Rocque
Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care
University of Alabama at Birmingham