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临床试验/NCT05203614
NCT05203614已完成不适用

Positive Activities for Asian American Cancer Patients and Caregivers

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Quality of Life Questionnaires(HRQOL & interpersonal well-being )

研究概览

简要总结

Positive Activities for Asian American Cancer Patients and Caregivers

详细描述

Primary Objectives:

The overall objective of this project is to design and test the feasibility of two positive activities, household contribution and outside contribution, to increase quality of life in AA cancer patients.

Secondary Objectives:

Aim 1: To assess the acceptability and feasibility of household and outside contribution positive activities for AAs through a mixed qualitative and exploratory quantitative investigation.

Aim 2: To use the qualitative and quantitative data from Aim 1, in collaboration with the mentorship team, AA community members, and clinicians, to develop one or both positive activity intervention(s) (i.e., household or outside contribution) specifically for AA 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
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for patients will be:
  • self-identifies as AA,
  • males or females ages 25-75 years
  • within 1 year of any cancer diagnosis
  • actively undergoing systemic therapy (e.g., chemotherapy, radiation)
  • able to identify a caregiver (e.g., spouse) who lives in the same household and consents to participate in the study,
  • able to read, write, and speak English (i.e., English proficient; EP),
  • access to internet, computer/phone, and web browser.

排除标准

  • for patients will be:
  • 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
  • Inclusion criteria for caregivers will be:
  • identifies as AA,
  • patient considers them to be caregiver, -
  • access to computer/phone, internet, and web browser.
  • Exclusion criteria for caregivers will be:
  • unwilling or unable to participate in the study for any reason,
  • under the age of 18.

研究组 & 干预措施

Household Contribution

Other

Do something thoughtful or nice for your caregiver that would provide them with tangible support

干预措施: Household Contribution (Behavioral)

Outside Contribution

Other

Do something outside your home/household that contributes to the larger society

干预措施: Outside Contribution (Behavioral)

Control

Other

Keep track of your daily activities

干预措施: Control (Behavioral)

结局指标

主要结局

Quality of Life Questionnaires(HRQOL & interpersonal well-being )

时间窗: through study completion, an average of 1 year

Hedonic well-being (positive and negative emotions) will be measured using a modified 12-item Affect-Adjective Scale (AAS)42 that includes low-arousal emotion items (e.g., peaceful/serene, dull/bored).

Affect-Adjective Scale

时间窗: End-of-study (4 weeks)

Positive and negative affect were measured using a modified 12-item Affect-Adjective Scale (AAS) (Diener \& Emmons, 1984) that included low-arousal emotion items (e.g., peaceful/serene, dull/bored). Participants rated the extent to which they experienced positive and negative emotions over the past week on a scale from 0 ("not at all") to 6 ("extremely").

Health-Related Quality of Life

时间窗: End-of-study (4 weeks)

HRQOL was measured using the 10-item Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) (Cella et al., 2010), with physical and mental health subscales. The scale ranges from 5 to 20 with higher scores indicating better health-related quality of life.

Perceived Stress

时间窗: End-of-study (4 weeks)

Perceived stress was measured using the 4-item Perceived Stress Scale (PSS) (Cohen \& Willliamson, 1988), which assessed the frequency of stressful experiences over the past month. The scale ranges from 0 to 16 with higher scores indicating greater perceived stress.

次要结局

  • Psychological Needs(End-of-study (4 weeks))
  • Self-Perceived Burden(End-of-study (4 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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