Positive Activities for Asian American Cancer Patients and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)
研究概览
简要总结
The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.
详细描述
This study will introduce two new positive activities, household contribution and outside contribution, which have been specifically created for AA cancer patients and have not been previously investigated. These interventions have been developed with consideration of culture-related challenges, Hofstede's concept of collectivist cultures, and self-determination theory. This study will be the first randomized controlled trial to assess the impact of these new positive activities on Asian-American cancer patients.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Patients:
- •self-identifies as Asian American or Asian
- •males or females ages 21-80 years
- •within 2 years of any cancer diagnosis or stage 4 cancer diagnosis
- •actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
- •able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
- •able to read, write, and speak English (i.e., English proficient; EP) or Mandarin/simplified Chinese.
排除标准
- •for patients:
- •life expectancy less than 6 months in the opinion of the primary physician
- •inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
- •major thought disorder (e.g., schizophrenia or bipolar [patient records or self-disclosure]).
- •Inclusion Criteria for Caregivers:
- •identifies as Asian American or Asian,
- •patient considers them to be caregiver
- •English proficient or Mandarin Chinese proficient
- •access to computer/phone, internet, and web browser.
- •Exclusion Criteria for Caregivers:
- •unwilling or unable to participate in the study for any reason,
- •under the age of 18.
研究组 & 干预措施
Contribution
Contribution to caregiver wellbeing via household tasks. If the household contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the well-being of their caregiver (e.g., cook a meal, take pet for a walk, water the plants). If the outside contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the world outside of their own home (e.g., pick up litter in neighborhood, buy coffee for stranger, donate food/clothing to homeless)
干预措施: Contribution to Caregivers Well-Being (Behavioral)
Control Group
Participants in the control group will be asked to factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet
干预措施: Control (Behavioral)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10)
时间窗: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
Primary Outcome Measure: health-related quality of life scores range from 3 to 15, with higher scores indicating better physical health scores range from 4 to 20, with high scores indicating better mental health
Affect-Adjective Scale (modified) (AAS)
时间窗: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)
Primary Outcome Measure: affective well-being scores range from 0-6, with 6 indicating higher negative or positive affect
次要结局
- Balanced Measure of Psychological Needs (BMPN)(Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks))
- Self-Perceived Burden Scale(Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks))
研究者
Lilian Shin-Cho
Principal Investigator, Assistant Professor
Fox Chase Cancer Center