Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer: A Preliminary Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
研究概览
简要总结
The goal of this clinical trial is to learn if a brief writing intervention works to improve quality of life outcomes in adult patients newly diagnosed with advanced stage cancer.
详细描述
A diagnosis of cancer may challenge one's former assumptions and beliefs about themselves and the world and potentially compromise quality of life (QoL). The primary aim of the study is to explore the preliminary efficacy of an intervention to protect individuals from the negative psychological impact of the cancer diagnosis. The secondary aim is to test the validity of the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 item Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be enrolled from two study sites as per protocol: the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Hospice respectively, and will be asked to write as guided by the researcher for 4 weeks. Study outcomes will be assessed at baseline, 2-, 6- and 8-weeks post baseline. It is hypothesized that self-affirmation via writing at the time following a diagnosis of an advanced cancer by affirming values or beliefs that are salient to self will help enhance self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and improve QoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •within 8 weeks of being informed of diagnosis (primary or recurrent)
- •cancer stage III or IV of a primary solid tumor, or a high-grade hematological malignancy, and
- •age 18 years or older
排除标准
- •medical condition precluding participation (e.g., too ill or fatigued, acute mental confusion as determined by the treating physician), or
- •enrolled in other psychosocial experiments
结局指标
主要结局
Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
时间窗: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem.
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
时间窗: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life. Each subscale ranging from 0 to 28, with higher score indicating higher level of quality of life. The raw scores of overall QoL (total FACT-G), four composite domains (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB; functional well-being, FWB), global QoL (item Gf7 "I am content with the quality of my life right now") and one item pertinent to this study (Ge6 "I worry that my condition will get worse") were presented below.
次要结局
- Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline(Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4))
- Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline(Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4))