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Trial Title:
A Single Arm Pilot Trial of a Social Network Intervention
NCT ID:
NCT05745038
Condition:
Cancer
Conditions: Official terms:
Zaleplon
Conditions: Keywords:
geriatric oncology
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
SONATA
Description:
The SONATA intervention is composed of five components, network diagnostics, network
engagement, opportunity creation, skill building and goal-setting, and feedback, that
will be audio-recorded and held over six scheduled sessions.
Arm group label:
Arm 1 - SONATA Intervention
Summary:
The purpose of this study is to see if a social network support program (SOcial Networks
to Activate Trust & Adherence or SONATA) is helpful for older individuals receiving
cancer treatment. The SONATA program will last for about 4 months. There are a total of 6
coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks.
Session 6 or the final session will be held approximately 1 to 2 months after session 5.
Each session will last for about 1 to 2 hours.
Criteria for eligibility:
Criteria:
Patient
Inclusion Criteria:
- Age ≥65 years
- A diagnosis of cancer
- Planning to initiate or during first three months of oral anticancer treatments
- Able to identify at least one network member to participate with them
- Able to speak English
- Able to provide informed consent
Exclusion Criteria:
- Any psychiatric or cognitive impairments interfering with participation as
determined by the treating oncology team
- Enrolled on oral anticancer therapeutic trials
Network Members:
Inclusion Criteria:
1. Age ≥18 years
2. Identified as a network member by subjects enrolled on the study (up to 10 network
members)
3. Able to speak English.
4. Able to provide informed consent
Exclusion Criteria:
None
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kah Poh Loh
Phone:
585-276-4353
Email:
Kahpoh_Loh@URMC.Rochester.edu
Investigator:
Last name:
Kah Poh Loh
Email:
Principal Investigator
Start date:
November 29, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745038
