Health TrialsbyHealthPanel

A Single Arm Pilot Trial of a Social Network Intervention

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥60 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

Age ≥18 years

Identified as a network member by patient subjects (up to 10 network members)

Able to speak English

Able to provide informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • SONATA

    Behavioral

    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.

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: Arm 1 - SONATA InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - SONATA Intervention

Number of patients approached who consent

Time frame
20 Weeks
2

Acceptability- SONATA Intervention

Average general acceptability score using the Theoretical Framework of Acceptability questionnaire. An eight item (range 1 to 5 for each item) psychometrically validated and theoretically informed tool which assesses the following constructs - affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability.

Time frame
20 Weeks

Secondary outcomes

1

Estimate - Social Support

Assessed using the Medical Outcomes Study Social Support Survey. The Medical Outcomes Study Social Support Survey is a 19-item survey (range 1-5 for each item) to assess four domains of emotional/informational support, instrumental support, positive social interaction, and affection; higher scores indicate greater social support. Subjects will be asked about their perceptions of their own social support.

Time frame
20 Weeks
2

Estimate - Trust in Healthcare Professionals

Assessed using the the Human Connection (THC) Scale. The THC scale is A 16-item scale (range 1 to 4 for each item); higher scores indicate greater trust.

Time frame
20 Weeks
3

Estimate - Adherence to oral anticancer treatments

Assessed using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence). The DOSE-Nonadherence scale is a three-item scale (range from none of the time to every time for each item) with eighteen additional items that assesses reasons for non-adherence.

Time frame
20 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Source ClinicalTrials.gov
Apply now