A Pilot Study of 'Take the Fight' as Community-Based Participatory Research
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale
研究概览
简要总结
This pilot clinical trial studies Take the Fight in supporting and empowering patients with cancer through their treatment process. Patients with cancer are faced with many obstacles created by the current state of the healthcare system. The purpose of Take the Fight is to train college students, also called patients' navigators or strategists, to assist and support patients to navigate into the healthcare system and receive the care they need. The strategists are matched with patients and attend/coordinate most patients' medical appointments. The strategists also advance communications between the patient and the medical staff to facilitate both the exchange of medical information as well as increase the patient's compliance with treatment. Take the Fight may improve the health and quality of life outcomes of cancer patients during critical treatment periods by increasing treatment compliance, eliminating barriers to better care, and increasing clinical trial participation.
详细描述
PRIMARY OBJECTIVES:
I. Delineate the benefits of and limitations to having Take the Fight strategists, performing as lay-navigators, as perceived by both the patients and the students.
SECONDARY OBJECTIVES:
I. Investigate changes in self-reported outcomes for patients and the Take the Fight strategists.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS ELIGIBILITY CRITERIA
- •Have histologically confirmed cancer
- •Karnofsky performance scale (KPS) score of >= 60
- •The ability to understand and be willing to sign an informed consent document
- •Willing to undergo a form of cancer therapy and subsequent follow-up care
- •STRATEGISTS INCLUSION CRITERIA
- •Age >= 18 years
- •Wake Forest University student
- •Have volunteered as a student strategist at Comprehensive Cancer Center of Wake Forest University (CCCWFU); all strategists are required to have gone through Take the Fight (TTF) training prior to their volunteer work
排除标准
- 未提供
研究组 & 干预措施
Supportive care (Take the Fight)
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks. Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (Take the Fight)
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks. Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
干预措施: Questionnaire Administration (Other)
Supportive care (Take the Fight)
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks. Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
干预措施: Supportive Care (Procedure)
结局指标
主要结局
Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale
时间窗: Baseline to up to 10 weeks
Change in patients self-reported outcomes using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Cancer 30 (QLQ-C30) questionnaire
时间窗: Baseline to up to 18 weeks
Descriptive statistics will be measured, including frequencies, percentages, means and standard deviations of patient self-report measures will be calculated. Ninety-five percent confidence intervals will also be calculated for the outcomes measures at each time point.
次要结局
未报告次要终点