CancerSONATANCT05745038
A Single Arm Pilot Trial of a Social Network Intervention
A study testing SONATA in people with Cancer, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- SONATA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 1) Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team
- Network Members:
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Kah Poh Loh, 585-276-4353, Kahpoh_Loh@URMC.Rochester.edu
Kah Poh Loh
About this study
Official title: A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer
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.
Read the 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.]
- Conditions
- Cancer
- Being tested
- SONATA
- Keywords
- geriatric oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONATABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - SONATA Intervention | Experimental | Not described Receives: Behavioral: SONATA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - SONATA Intervention
Number of patients approached who consent
Measured: 20 Weeks
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.
Measured: 20 Weeks
Secondary outcomes (3)
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.
Measured: 20 Weeks
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.
Measured: 20 Weeks
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.
Measured: 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start29 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
- Investigators
- Kah Poh Loh, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745038
- Sponsor's protocol ID
- UOCPC22065
- Acronym
- SONATA
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and dataset will be shared upon request from the PI
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer
- ClinicalTrials.gov ID
- NCT05745038
- Acronym / sponsor ID
- SONATA / UOCPC22065
- Conditions
- Cancer
- Keywords
- geriatric oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.]
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - SONATA Intervention | Experimental | Behavioral: SONATA |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Age ≥18 years
Key exclusion criteria (3 listed)
- 1) Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SONATAThe 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. | Behavioural | Arm 1 - SONATA Intervention |
Primary outcome
Feasibility - SONATA Intervention
Time frame: 20 Weeks
Number of patients approached who consent
Acceptability- SONATA Intervention
Time frame: 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.
3 secondary outcomes
Estimate - Social Support
Time frame: 20 Weeks
Estimate - Trust in Healthcare Professionals
Time frame: 20 Weeks
Estimate - Adherence to oral anticancer treatments
Time frame: 20 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Study protocol and dataset will be shared upon request from the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kah Poh Loh principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SONATA in people with Cancer, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kah Poh Loh (585-276-4353, Kahpoh_Loh@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - SONATA Intervention (time frame: 20 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.