跳至主要内容
临床试验/NCT01586416
NCT01586416Unknown不适用

Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Participant satisfaction with intervention structure, timing and content

研究概览

简要总结

The purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. The investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 or older
  • Verbal fluency in English
  • Diagnosis of colon cancer
  • Scheduled to initiate chemotherapy treatment for colon cancer

排除标准

  • Active, unstable, untreated serious mental illness interfering with ability to participate
  • Cognitive impairment interfering with ability to participate
  • Receiving radiotherapy concomitant with chemotherapy

结局指标

主要结局

Participant satisfaction with intervention structure, timing and content

时间窗: At approximately 12 weeks post-baseline

Participants rate acceptability of structure, timing and content of intervention using Likert-type response scales, and are also invited to provide brief qualitative feedback on opinions about intervention.

Number of participants who withdraw from study after enrollment

时间窗: At approximately 12 weeks post-baseline

次要结局

  • Change from baseline in the Hospital Anxiety and Depression Scale(At approximately 12 weeks post-baseline)
  • Change from baseline in the Symptom Distress Scale(At approximately 12 weeks post-baseline)
  • Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount(At approximately 24 weeks post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Traeger

Assistant in Psychology

Massachusetts General Hospital

研究点 (2)

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