A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Information Satisfaction Questionnaire (ISQ)
研究概览
简要总结
The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.
详细描述
There will be two phases of the study. In "Phase I", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. This group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. In "Phase II", which will occur after "Phase I" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. The same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. This will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. Comparison of these two groups of participants will provide the baseline data to plan future interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer.
- •Patients who have a treatment plan including both chemotherapy and radiation.
- •Patients who will be undergoing treatment at Massachusetts General Hospital Cancer Center.
- •Ability to speak and read in English in order to be able to complete questionnaires with minimal assistance required from a family member.
排除标准
- •Patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy)
- •Patients who cannot speak, read and write in English with minimal assistance from a family member.
- •Patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials.
- •Patients who will not be receiving their cancer treatment at MGH.
结局指标
主要结局
Information Satisfaction Questionnaire (ISQ)
时间窗: Baseline, 4 Months, 6 Months
The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.
次要结局
- Percentage of participant change of scores of psychological distress(Baseline, 4 Months, 6 Months)
- Percentage of Participant illness perception(Baseline, 4 Months, 6 Months)
- Percentage of change participant symptom burden(Baseline, 4 Months, 6 Months)
研究者
Lori J. Wirth, MD
Principal Investigator
Massachusetts General Hospital