Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Change in depression/distress
研究概览
简要总结
This study investigates the extent to which lifestyle factors including mental health, social support, diet, and exercise are associated with quality of life and melanoma patient outcomes. Knowledge gained from this study may be used to guide the design of prospective clinical trials of lifestyle interventions to improve the outcomes of melanoma patients and assist doctors in counseling their patients.
详细描述
PRIMARY OBJECTIVES:
I. Collect systematic data on mental health, quality of life (QOL), social support, diet, and exercise behaviors in melanoma patients.
II. Examine whether psychosocial factors and lifestyle are associated with clinical outcomes in melanoma patients.
III. Examine the association between lifestyle and psychosocial factors and tissue and blood biomarkers in melanoma patients.
IV. Examine whether psychosocial factors and lifestyle are associated with QOL adjustment in melanoma patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology
- •Able to read and understand English
- •Willing to complete an online or paper survey
排除标准
- 未提供
研究组 & 干预措施
Observational (questionnaire, medical chart review)
Patients complete a maximum of 3 paper or electronic questionnaires over 30 minutes within 2 weeks of presentation to MD Anderson, new diagnosis of melanoma, and/or initiating a new treatment, within 2 weeks of first restaging, and within 2 weeks of the end of treatment. Patients may complete an additional paper or electronic dietary questionnaire over 10 minutes for 3 days (30 minutes total) or a phone-based dietary recall. Patients who start a new treatment of interest may repeat the questionnaires at the same time points. Patients' medical records are also reviewed.
干预措施: Medical Chart Review (Other)
Observational (questionnaire, medical chart review)
Patients complete a maximum of 3 paper or electronic questionnaires over 30 minutes within 2 weeks of presentation to MD Anderson, new diagnosis of melanoma, and/or initiating a new treatment, within 2 weeks of first restaging, and within 2 weeks of the end of treatment. Patients may complete an additional paper or electronic dietary questionnaire over 10 minutes for 3 days (30 minutes total) or a phone-based dietary recall. Patients who start a new treatment of interest may repeat the questionnaires at the same time points. Patients' medical records are also reviewed.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in depression/distress
时间窗: Up to 10 years
Will be assessed using the Centers for Epidemiologic Studies - Depression. Lifetime history of Major Depressive Disorder (MDD) will be measured using the two cardinal items from the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV Disorder. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time.
Change in cancer-related symptoms
时间窗: Up to 10 years
Will be assessed using the MD Anderson Symptom Inventory. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time.
Associations between mental health, social support, diet and exercise behaviors, and quality of life and demographic variables
时间窗: Up to 10 years
Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.
Change in anxiety
时间窗: Up to 10 years
Will be assessed using the Speilberger State/Trait Anxiety Inventory. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time.
Change in social support
时间窗: Up to 10 years
Will be assessed using the 24-item Social Provisions Scale. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time.
Change in general eating habits
时间窗: Up to 10 years
Will be assessed using the National Cancer Institute National Health and Nutrition Examination Survey Dietary Screener Questionnaire, and optionally, the National Institutes of Health Automated Self-Administered 24-hour.
Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on progression free survival
时间窗: Up to 10 years
Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.
Change in physical activity
时间窗: Up to 10 years
Will be assessed using the Godin Leisure -Time Exercise Questionnaire. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time.
Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on cancer mortality
时间窗: Up to 10 years
Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.
Response to treatment
时间窗: Up to 10 years
Logistic regression models will be used to measure the association of diet, physical activity, diet, depressive symptoms, distress, lifetime MDD, and social support and response to treatment at each time point.
次要结局
未报告次要终点