A Pilot Randomized Controlled Trial of a Social Network Intervention
Purpose
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.
Conditions
- Advanced Cancer
- Older Adults (65 Years and Older)
- Social Networks
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
No Intervention Enhanced Usual Care |
Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization. |
|
Recruiting Locations
Rochester, New York 14642
More Details
- Status
- Recruiting
- Sponsor
- University of Rochester
Detailed Description
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.