A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Geriatric Oncology Collaborative Care
Patients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise.
干预措施: Geriatric Oncology Collaborative Care (Other)
Usual Care
Participants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist.
干预措施: Usual Care (Other)
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
Ryan Nipp
Principal Investigator
Massachusetts General Hospital