Cancer
Conditions
Keywords
geriatric oncology
Brief 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.
Detailed 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 \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]
Interventions
BEHAVIORALSONATA
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.
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
None (Open Label)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - SONATA Intervention | 20 Weeks | Number of patients approached who consent |
| Acceptability- SONATA Intervention | 20 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate - Social Support | 20 Weeks | 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. |
| Estimate - Trust in Healthcare Professionals | 20 Weeks | 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. |
| Estimate - Adherence to oral anticancer treatments | 20 Weeks | 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. |
Countries
United States
Contacts
CONTACTKah Poh Loh
CONTACTBecky Gravenstede
PRINCIPAL_INVESTIGATORKah Poh Loh
University of Rochester
Outcome results
None listed