Feasibility of a Positive Activity Intervention in Cancer Patients From Collectivist Cultures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Consent rate
研究概览
简要总结
This clinical trial studies the feasibility of two positive activities in improving quality of life in collectivist culture cancer patients and their caregivers. Cancer patients of collectivist cultures (e.g., Latinos, Asian Americans, African Americans) have been found to experience lower quality of life and more distress and depression when compared to those of individualist cultures, such as European Americans. Following a cancer diagnosis, collectivist patients may experience a change in their relationships with other family members and their roles within the family. The cancer diagnosis may lead to changes in roles and responsibilities, such as when a male breadwinner is no longer able to work due to hospital treatments. The two positive activities are designed to increase a sense of competence, autonomy, and connectedness, including contributing to household responsibilities (an act of kindness) and writing a letter of gratitude. Performing certain simple activities may improve quality of life in cancer patients and their caregivers.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of conducting a study of two positive activities intended to improve the psychological and interpersonal well-being of cancer patients from collectivist cultures.
SECONDARY OBJECTIVES:
I. To preliminarily assess changes in psychological, interpersonal, and physical well-being of the intervention patients and caregivers compared to control patients and caregivers.
II. To preliminarily assess changes in psychological, interpersonal, and physical well-being of patients and caregivers who are members of collectivist cultures (African American, Asian American, or Latino/Hispanic) compared to patients and caregivers who are members of individualist (European American) cultures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS: Between 35 -70 years of age
- •PATIENTS: Within 1-5 years of diagnosis and actively undergoing systemic therapy, including chemotherapy, immunotherapy, endocrine and radiation therapies
- •PATIENTS: Self-identify as ethnically one of the 4 ethnic groups of focus: Asian American, African American, Latino, and European American. For collectivist cultures, will aim to recruit patients of who are first- (i.e., immigrated to United States [US]) or second-generation (i.e., children of US residents who immigrated to US) immigrants
- •PATIENTS: Diagnosed with any type of cancer
- •PATIENTS: Able to identify a caregiver (e.g., family member) who lives in the same household, and who consents to participate in this study
- •PATIENTS: Able to read, write, and speak in English
- •PATIENTS: Access to internet, computer or phone, and web browser
- •CAREGIVERS: Patient considers them as their caregiver
- •CAREGIVERS: Lives in the same household as patient
- •CAREGIVERS: Able to read, write, and speak in English
- •CAREGIVERS: Access to internet, computer or phone, and web browser
- •CAREGIVERS: Identifies as the same race/ethnicity group as the patient (e.g., European American wife and European American husband, or Asian American wife and Asian American husband would be pairs that are considered eligible)
排除标准
- •PATIENTS: Life expectancy less than 6 months in the opinion of the primary physician
- •PATIENTS: Inability to stand and walk on their own or with other physical limitations that preclude them from participating. (3+ on Eastern Cooperative Oncology Group [ECOG] performance status)
- •PATIENTS: Major depression (e.g., as determined by a score of 10 or higher on the 10-item Center for Epidemiologic Studies Depression Scale [CES-D] at baseline, out of 30) or diagnosed prior to study (from patient records and/or self-disclosure by patient)
- •CAREGIVERS: Unwilling or unable to participate in the study for any reason
- •CAREGIVERS: Under the age of 18
结局指标
主要结局
Consent rate
时间窗: 4 weeks
Will calculate the 95% confidence intervals (CIs) for the consent rate.
Intervention adherence rate
时间窗: 4 weeks
Will calculate the 95% CIs for the intervention adherence rate.
Study completion rate
时间窗: 30 days
The study completion rate is defined as the average proportion of participants who complete follow-up assessments at the end of the study (day 30). Will also calculate the 95% CIs for the study completion rate.
次要结局
- Changes in interpersonal well-being of the intervention patients(Baseline up to 28 days)
- Changes in physical well-being of the intervention caregivers(Baseline up to 28 days)
- Changes in psychological well-being of the intervention caregivers(Baseline up to 28 days)
- Changes in interpersonal well-being of the intervention caregivers(Baseline up to 28 days)
- Changes in psychological well-being of the collectivist culture patients(Baseline up to 28 days)
- Changes in physical well-being of the intervention patients(Baseline up to 28 days)