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临床试验/NCT03721926
NCT03721926已完成不适用

A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2019年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
2
主要终点
Rates of study enrollment

研究概览

简要总结

The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers.

详细描述

Cancer disproportionately affects older adults, and the number of older adults with cancer is expected to grow as the population ages. Older adults with advanced cancer often possess a distinct set of medical and psycho-social issues that makes caring for the geriatric oncology population challenging for oncologists. Currently, a critical knowledge gap exists regarding how best to deliver comprehensive cancer care targeting the unique geriatric and palliative care needs of these individuals. The investigators propose to develop a geriatric oncology collaborative care intervention to improve supportive care outcomes for older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancer. GI and GU cancers are among the leading causes of cancer death in the geriatric cancer population, and patients with advanced GI and GU cancers experience a high symptom burden. The intervention will entail visits with an oncology advanced practice nurse trained to address patients' unique needs, who will meet regularly with a supervising team of geriatric, palliative care, social work, and pharmacy clinicians for feedback and iterative reevaluation of the care plan. Using nurses who are already integrated into the oncology setting represents a scalable model that addresses the workforce shortage of geriatric and palliative care clinicians. The investigators used conceptual models for collaborative care and geriatric interventions to develop an initial intervention framework, and prior research to develop a preliminary intervention manual. In Aim 1, the investigators will refine and finalize both the intervention and the intervention manual based on qualitative data from patients, caregivers, and clinicians to ensure the intervention targets the unique needs of older adults with advanced cancer. In Aim 2, the investigators will modify the intervention and study methods with an open pilot study (n=10). In Aim 3, the investigators will conduct a pilot randomized trial (n=75) to assess the feasibility and preliminary efficacy of the geriatric oncology collaborative care intervention for improving patients' QOL, symptom burden, and functional outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65 or older
  • Diagnosed with advanced (defined as metastatic or receiving therapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, renal, bladder, or prostate cancer within the past 8 weeks (includes patients with a new diagnosis, progression or recurrence).
  • ECOG performance status of 0-2
  • Ability to read and respond to questions in English
  • Planning to receive care at MGH

排除标准

  • Uncontrolled psychiatric illness or impaired cognition

结局指标

主要结局

Rates of study enrollment

时间窗: 3 years

To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).

次要结局

  • Longitudinal effects of the intervention on Depression Symptoms(6 months)
  • Change in Activities of Daily Living(6 months)
  • Change in number of falls(6 months)
  • Rates of study completion(3 years)
  • Change in depression symptoms(6 months)
  • Cange in psychological distress(6 months)
  • Longitudinal effects of the intervention on Activities of Daily Living(6 months)
  • Change in Instrumental Activities of Daily Living(6 months)
  • Longitudinal effects of the intervention on Instrumental Activities of Daily Living(6 months)
  • Change in Quality of Life(6 Months)
  • Change in Symptom Burden(6 months)
  • Longitudinal effects of the intervention on Quality of Life(6 months)
  • Longitudinal effects of the intervention on Symptom Burden(6 months)
  • Longitudinal effects of the intervention on psychological distress(6 months)
  • Longitudinal effects of the intervention on number of falls(6 months)

研究者

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

Ryan Nipp

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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