Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Functional Assessment of Cancer Therapy - General (FACT-G)
研究概览
简要总结
Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.
详细描述
The team has developed a brief Patient Participation Aid (PPA) to promote patient health literacy and encourage women to be active in the decisions that are being made about their healthcare which will lead to their satisfaction with healthcare and improves their psychosocial well-being. The paper-based PPA uses adult learning principles to limit and sequence plain language messages that have been framed from a patient's perspective. The PPA uses theory-based design to increase patients' involvement in the medical visit by modeling - through text and images - how a patient can: 1) set the visit agenda, 2) formulate questions, and 3) assert personal preferences. The specific aims of this study are to: 1- Assess the effectiveness of the PPA to increase patient involvement during clinical encounters. 2- Evaluate the effectiveness of the PPA to improve patient psychosocial outcomes. 3- Explore if the effect of the PPA varies by patients' literacy skills. To achieve this aims, the investigators will conduct a randomized controlled trial to evaluate the PPA among patients with a new diagnosis or progression of metastatic breast cancer at two cancer centers that serve diverse patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics
- •age 21 or older
- •having suspected progression of metastatic disease
排除标准
- •patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician
- •patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention
- •patients too ill to meaningfully converse with the physician
研究组 & 干预措施
Intervention
Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. Then they will be helped through the Patient-Participation Aid (PPA) by the research assistant (RA). Then they will meet with their doctor while the visit is video-recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication. Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.
干预措施: Patient-Participation Aid (Behavioral)
Usual Care
Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. They will have their doctor's visit video recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication.Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.
结局指标
主要结局
Functional Assessment of Cancer Therapy - General (FACT-G)
时间窗: Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit
Evaluated at 30 minutes prior to, one week after, and 3 months after the patients visit with their doctor, this measure collects scales of the social and family well-being, emotional well-being, and functional well-being.
次要结局
- Rapid Estimate of Adult Literacy in Medicine (REALM-SF)(Pre-Visit)
研究者
Marla L Clayman
Adjunct Faculty
Northwestern University