A Pilot Randomized Controlled Trial of a Social Network Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
Unwilling to complete study procedures
Age ≥18 years
Identified as an SN member by the patient in the intervention arm
Trial design
Design model
Parallel
Treatments tested in this trial
SONATA
BehavioralSONATA includes six evidence-based components to help patients: 1) identify and set personal goals to achieve well-being (goal-setting); 2) identify their social network (SN) members and map their SNs (network diagnostics); 3) engage key SN members to address their goals and needs (network engagement); 4) build channels for communication and collaboration with key SN members via in-person and virtual activities (opportunity creation); 5) communicate effectively with their key SN members, develop action plans, and provide support (skill building); and 6) engage in cycles of feedback to effectively respond to the patient's evolving needs.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: SONATA InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Study feasibility
Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
Time frame
From baseline to week 16Secondary outcomes
1
Emotional, social, and existential quality of life
14-item McGill QoL Questionnaire-Revised. A 14-item survey assessing quality of life. It has four subscales: Physical, Psychological, Existential, and Social. We will focus on Psychological, Existential, and Social subscales. Mean scores range from 0 to 10, higher scores are better
Time frame
From baseline to week 162
Patient Activation
Patient Activation Measure. A 13-item survey to assess patient knowledge, skill, and confidence for self-management. Total scores range from 0 to 100, higher scores are better.
Time frame
From baseline to week 16.3
Autonomy, Competence, and Relatedness
Basic Psychological Need Satisfaction Scale. A 21-item survey to assess the degree to which people feel satisfaction of these three needs - autonomy, competence, and connectedness. Total scores range fom 21 to 147, higher scores are better.
Time frame
From baseline to week 164
Social Support
Medical Outcomes Study-Social Support Survey. A 19-item survey to assess four domains of emotional/informational support, instrumental support, positive social interaction, and affection. Total scores range from 0-100, higher scores are better.
Time frame
From baseline to week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov