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临床试验/NCT00836992
NCT00836992已完成不适用

Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2009年1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
Mayo Clinic
入组人数
144
试验地点
1
主要终点
Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA

研究概览

简要总结

RATIONALE: Gathering information about patients' quality of life during radiation therapy for cancer may help doctors plan the best treatment.

PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.

详细描述

OBJECTIVES:

  • To determine if patient-reported quality of life (QOL) can be improved by the real-time use of QOL data in patients with primary lung, head and neck, or gastrointestinal cancer undergoing radiotherapy.
  • To obtain preliminary estimates for effect sizes on differences in key QOL domains between patients receiving real time QOL data and those not receiving QOL data.
  • To obtain preliminary estimates of differences in patient satisfaction between patients receiving real time QOL data and those not receiving QOL data.
  • To determine whether the availability of real-time QOL assessments in a radiation oncology practice increases the acceptance and utilization of QOL data by a clinical oncology team.
  • To evaluate clinician attitudes towards the incorporation of real-time QOL data into oncology patient management.
  • To evaluate the use of a set of clinical pathways for the incorporation of real time QOL data into oncology patient management.
  • To evaluate the potential impact on the quality of the patient-physician relationship with real-time use of QOL data compared to interactions where quality of life data are not utilized.
  • To obtain preliminary estimates of whether the real-time use of QOL data in a radiation oncology practice significantly increases the duration of the weekly on treatment visit.

OUTLINE: Patients are randomized to 1 of 2 groups.

  • Group 1 (control): Patients complete QOL assessments (e.g., the Linear Analog Self Assessment [LASA]) at weeks 1, 3, and 5 during treatment and the last week of treatment. They also complete the Interpersonal Patient-Provider Relationship Scale (IPPRS) and Was it Worth It (WIW) questionnaires on the final day of treatment. Data is not shared with the physician, the patient, or any other clinical assistant that may be supporting the physician (e.g. nurse, or nurse practitioner).
  • Group 2 (active): Patients complete QOL assessments (e.g., LASA) and the IPPRS and WIW questionnaires as in group 1. Information from the questionnaires is shared with the physician, nurse, and/or nurse practitioner and the patient immediately prior to the on-treatment visit.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA

时间窗: 7 Weeks

次要结局

  • Proportion of cases for which the clinical team indicates that the clinical pathways contributed positively to patient management, the number of cases which the clinicians report referrals were generated, and the qualitative data derived from the pos ...(One month post study)
  • Percentage of patients for which physician reports indicate that availability(7 Weeks)
  • Component QOL domains reported on the five numerical analogue items (physical, intellectual, emotional, spiritual, and social QOL), average pain item and fatigue reported in the LASA(7 Weeks)
  • Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment(7 Weeks)
  • Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews(One month post study)
  • Average physician rating of the patient-physician relationships for the two treatment groups(7 Weeks)
  • Average duration of the weekly on treatment visit for the two treatment groups(7 Weeks)
  • Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment(7 Weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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