A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Study feasibility
研究概览
简要总结
This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention. In addition, it will assess the preliminary efficacy of SONATA compared to enhanced usual care among 70 older adults with advanced cancer.
详细描述
Older adults (aged ≥65) with advanced cancer are living longer due to more effective treatments, but their median survival remains around one year. We have shown that this population experiences a high prevalence of aging-related conditions, including functional and cognitive impairments, as well as depressive and anxiety symptoms. These conditions heighten their vulnerability to treatment toxicities and increase their need for assistance with daily activities. Together, these challenges impair older adults' ability to manage their care (patient activation) and reduce their overall quality of life (QoL). Therefore, interventions are needed to increase patient activation and improve QoL in this vulnerable population.
Fostering supportive social networks (SNs) can help older adults navigate the burden of cancer and its treatments. SNs comprise individuals (e.g., family members and friends) connected by interpersonal relationships. SN members offer a range of support, including instrumental, emotional, and informational support. They play pivotal roles in clinical settings, particularly for older individuals with functional impairments. SN members attend clinic visits and advocate for patients, ensuring accurate exchange and filtering of information to align with patients' preferences. SN members also shape patients' identities, coping strategies, and disease understanding. The role of SNs becomes more prominent as older adults become more ill.
The SOcial Networks to Activate Teamwork & Alliance (SONATA) intervention was designed to harness the SNs to provide support to older adults with advanced cancer and increase patient activation and improve QoL. The objective of this study is to conduct a pilot randomized controlled trial assessing SONATA compared to enhanced usual care among 70 older adults with advanced cancer.
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
- •Inclusion criteria:
- •Age ≥65 years
- •A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
- •Able to speak English
- •Able to provide informed consent
排除标准
- •Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
- •Unwilling to complete study procedures
- •Social Network Members (if available, for intervention arm only)
- •Inclusion criteria:
- •Age ≥18 years
- •Identified as an SN member by the patient in the intervention arm
- •Able to speak English
- •Able to provide informed consent
- •Exclusion criteria:
- •Unwilling to complete study procedures
研究组 & 干预措施
SONATA Intervention
Following randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks.
干预措施: SONATA (Behavioral)
Enhanced Usual Care
Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization.
结局指标
主要结局
Study feasibility
时间窗: From baseline to week 16
Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
次要结局
- Emotional, social, and existential quality of life(From baseline to week 16)
- Patient Activation(From baseline to week 16.)
- Autonomy, Competence, and Relatedness(From baseline to week 16)
- Social Support(From baseline to week 16)
研究者
Kah Poh Loh
Associate Professor
University of Rochester