Clinical trial · Interventional
A Pilot Randomized Controlled Trial of a Social Network Intervention
A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer
NCT07393529CI-TRIAL-00117095SONATA 2recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Older Adults (65 Years and Older) | — | UNRESOLVED | — |
| Social Networks | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SONATA | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SONATA Intervention
- description
- 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.
- interventionNames
- Behavioral: SONATA
- type
- NO_INTERVENTION
- label
- Enhanced Usual Care
- description
- Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization.
Primary outcomes (1)
- measure
- Study feasibility
- timeFrame
- From baseline to week 16
- description
- Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Patients 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
References
Publications (2)
- BACKGROUNDKehoe L, Sanapala C, DiGiovanni G, Yousefi-Nooraie R, Yilmaz S, Bauer J, Loh KP, Norton S, Duberstein P, Kamen C, Gilmore N, Gudina A, Kleckner A, Mohile S, Epstein RM. Older adults with advanced cancer are selective in sharing and seeking information with social networks. Patient Educ Couns. 2022 Oct;105(10):3116-3122. doi: 10.1016/j.pec.2022.06.005. Epub 2022 Jun 9. PMID 35717349
- BACKGROUNDYu V, Yilmaz S, Freitag J, Loh KP, Kehoe L, Digiovanni G, Bauer J, Sanapala C, Epstein RM, Yousefi-Nooraie R, Mohile S. The role of social networks in prognostic understanding of older adults with advanced cancer. Patient Educ Couns. 2023 Jan;106:135-141. doi: 10.1016/j.pec.2022.10.009. Epub 2022 Oct 15. PMID 36270857