A Single Arm Pilot Trial of a Social Network Intervention (SONATA)

University of Rochester

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: SONATA

Study type: Interventional

Funder types: Other

Identifiers

NCT05745038

UOCPC22065

Details and patient eligibility

About

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.

Full description

The objective of this study is to conduct a single arm pilot study to assess the feasibility and acceptability of the SONATA intervention among older patients with advanced cancer. We hypothesize that the SONATA intervention will be feasible [≥70% enrolled patient subjects (excluding those who die during the study) will complete at least 3 of the SONATA sessions] and acceptable [average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.]

Enrollment: 330 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient

Inclusion Criteria:

1. Age ≥60 years
2. A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
3. Able to speak English
4. Able to provide informed consent

Exclusion Criteria:

1) Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team

Network Members:

Inclusion Criteria:

1. Age ≥18 years
2. Identified as a network member by patient subjects (up to 10 network members)
3. Able to speak English
4. Able to provide informed consent.

Exclusion Criteria:

None

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

Arm 1 - SONATA Intervention

Experimental group

Treatment:

Behavioral: SONATA