A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Functional and Cognitive health status
研究概览
简要总结
Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. While Survivorship research has improved our understanding of the challenges faced by some cancer survivors, there is a paucity of research on the functional and cognitive health status of head and neck cancer survivors.
The purpose of this study is to evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to increase our understanding of the complex interactions between cancer treatment, comorbid health ailments and quality of life.
详细描述
Cancer is the second leading cause of death in the United States today, accounting for nearly a quarter of total deaths. Due to advancements in cancer management, specifically in the areas of surveillance, early diagnosis, and utilization of evidenced-based therapies, there has been an increase in the number of survivors in the United States. As at 2007, there were over 11 million cancer survivors in the United States and this number is projected to reach 15 million by the end of 2010. Investigations into the quality of life experienced by these survivors have therefore become necessary if these survivors are to be effectively managed through their course of cancer.
The increase in the number of cancer survivors has opened up a relatively new avenue of cancer research termed Cancer Survivorship Research. Cancer Survivorship Research seeks to investigate the physical, functional and psychosocial consequences of cancer. Despite advances made in survivorship research, gaps remain in our knowledge concerning the ability of the cancer survivor to reintegrate into life and function at pre-cancer levels. These knowledge-gaps are especially true for head and neck cancer patients as demonstrated by the paucity of studies in the literature evaluating the functional and psychosocial consequences of cancer in this cohort. This is a significant short-coming especially since head and neck cancer patients are at increased risks for adverse consequences due to their advanced age at the time of cancer diagnosis, comorbidity burdens and substantial history of alcohol or tobacco use.
This study will evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to understand the consequences of cancer treatment on the quality of life experienced by these survivors.
Our study will use self-report questionnaires, neurocognitive assessments and novel performance-based assessments to evaluate functional and cognitive health status at two time-points:
- At Baseline (before any cancer treatment modality)
- After the first stage of cancer therapy (chemotherapy, radiation or surgery)
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 40 years of age or older.
- •Subjects must be able to read, write and speak English fluently.
- •Subjects must be newly diagnosed with head and neck squamous cell cancer.
- •Subjects must not have already had treatment for this cancer diagnosis.
- •Subjects must be anticipated to receive at least one of the following types of therapy: surgery, chemotherapy or radiation.
排除标准
- •Subjects with prior cancer diagnoses who have evidence of active disease.
- •Subjects who have received cancer treatment within the past year.
- •Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state).
- •Life expectancy of less than 3 months.
- •Subjects with melanoma or other non-squamous cell cancer.
- •Subjects who score >9 on Short Blessed Test (SBT) at baseline.
- •Subjects who are unable to complete all of the required forms and tasks at baseline, either because of cognitive deficits or physical limitations.
- •Any medical condition the PI determines to affect safe study participation.
结局指标
主要结局
Functional and Cognitive health status
时间窗: At the time of cancer diagnosis and Within 1 month of cancer therapy
次要结局
- Assess the effectiveness of novel performance-based tests in detecting subtle functional and cognitive health status changes(At the time of cancer diagnosis and Within 1 month of cancer therapy)
研究者
Jay F. Piccirillo, MD
Professor, Washington University School of Medicine
Washington University School of Medicine