Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Health Related Quality of Life as Measured by Perceived Stress Scale
研究概览
简要总结
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
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
- 否
入选标准
- •Greater than 18 years of age
- •Spanish or English speaker with ability to read one of these languages
- •Diagnosis of pancreatic cancer .
- •Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.
排除标准
- •Patients unable to read Spanish or English, as they will be unable to complete surveys.
- •History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review.
- •Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review.
- •Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
结局指标
主要结局
Health Related Quality of Life as Measured by Perceived Stress Scale
时间窗: Up to 10 weeks.
Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)
时间窗: Up to 10 weeks.
FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
时间窗: Up to 10 weeks.
FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)
Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale
时间窗: Up to 10 weeks.
UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)
Health Related Quality of Life as Measured by Interpersonal Support Evaluation List
时间窗: Up to 10 weeks.
Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).
The Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Up to 10 weeks.
GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)
次要结局
未报告次要终点
研究者
Frank Penedo
Professor
University of Miami