NCT01986712已完成不适用
An Observational Pilot Study to Compare the Compliance With and Health Related Quality of Life During Therapy With Standard High-Dose Interferon Alfa (Intron A, HDI) Versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients With Surgically Resected Melanoma
St. Luke's Hospital and Health Network, Pennsylvania4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
研究概览
简要总结
To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.
详细描述
The primary objective of this study is:
• To evaluate compliance with the administration of standard HDI versus PEG IFN for patients with melanoma in need of adjuvant therapy
The secondary objectives of this study are:
- To compare the convenience and satisfaction with chemotherapy for patients on standard HDI versus PEG IFN using a chemotherapy convenience and satisfaction questionnaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patient's HRQOL using the Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT BRM)
- To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN
- To examine reasons for patients' choice of treatment with HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option
- To assess Health Resource Utilization on both arms of the study
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
- •Patient is male or female at least 18 years of age
- •Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
- •Patient is willing and able to give written informed consent
- •Patient is willing to comply with all study requirements
排除标准
- •Patient is unable or unwilling to complete QoL questionaire or compliance diary
- •Patient has a history of anaphylaxis due to any interferon alpha product
- •Patient has autoimmune hepatitis
- •Patient has decompensated liver disease (Child-Pugh score>6 ( Class B and C)
- •Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements
结局指标
主要结局
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
时间窗: 1 year
To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy
次要结局
- Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN(baseline -week 1, week 3, week 13, week 25, week 50)
- Assess the Frequency of Grade 3 and Grade 4 Toxicities(baseline-week 1, week 3, week 13, week 25, week 50)
- Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN(baseline-week 1, week 3, week 13, week 25, week 50)
- Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)(Baseline-week 1, Week 3, week 13 week 25, week 50)
研究者
Neil Belman
Dr. Neil Belman
St. Luke's Hospital and Health Network, Pennsylvania
研究点 (4)
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