Advanced CancerSONATA 2NCT07393529
A Pilot Randomized Controlled Trial of a Social Network Intervention
A study testing SONATA in people with Advanced Cancer and Older Adults (65 Years and Older), run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advanced Cancer, Older Adults (65 Years and Older), Social Networks
- 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
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 31 Mar 2029
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- Age ≥18 years
- Identified as an SN member by the patient in the intervention arm
- Able to speak English
- Able to provide informed consent
Who cannot join
- Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
- Unwilling to complete study procedures
- Social Network Members (if available, for intervention arm only)
- Unwilling to complete study procedures
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
About this study
Official title: A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer
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.
Read the detailed description
Older adults (aged ≥65) with advanced cancer are living longer due to more effective treatments, but their median survival remains around one year. We have shown that this population experiences a high prevalence of aging-related conditions, including functional and cognitive impairments, as well as depressive and anxiety symptoms. These conditions heighten their vulnerability to treatment toxicities and increase their need for assistance with daily activities. Together, these challenges impair older adults' ability to manage their care (patient activation) and reduce their overall quality of life (QoL). Therefore, interventions are needed to increase patient activation and improve QoL in this vulnerable population.
Fostering supportive social networks (SNs) can help older adults navigate the burden of cancer and its treatments. SNs comprise individuals (e.g., family members and friends) connected by interpersonal relationships. SN members offer a range of support, including instrumental, emotional, and informational support. They play pivotal roles in clinical settings, particularly for older individuals with functional impairments. SN members attend clinic visits and advocate for patients, ensuring accurate exchange and filtering of information to align with patients' preferences. SN members also shape patients' identities, coping strategies, and disease understanding. The role of SNs becomes more prominent as older adults become more ill.
The SOcial Networks to Activate Teamwork \& Alliance (SONATA) intervention was designed to harness the SNs to provide support to older adults with advanced cancer and increase patient activation and improve QoL. The objective of this study is to conduct a pilot randomized controlled trial assessing SONATA compared to enhanced usual care among 70 older adults with advanced cancer.
- Being tested
- SONATA
- Keywords
- geriatric oncology, social networks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONATABehavioural
SONATA 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.
| Study group | Role | What they receive |
|---|---|---|
| SONATA Intervention | Experimental | Following randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks. Receives: Behavioral: SONATA |
| Enhanced Usual Care | No intervention | Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility
Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
Measured: From baseline to week 16
Secondary outcomes (4)
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
Measured: From baseline to week 16
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.
Measured: From baseline to week 16.
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.
Measured: From baseline to week 16
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.
Measured: From baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Apr 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- 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
- NCT07393529
- Sponsor's protocol ID
- UOCPC26005
- Acronym
- SONATA 2
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Permission will also be asked on the consent form for the use of patient and social network (SN) data for future research not described in this consent. In addition, permission will be asked from patients and SN members to share de-identified transcripts from recordings for future research not described in the consent.
Publications
Kehoe L, Sanapala C, DiGiovanni G, Yousefi-Nooraie R, Yilmaz S, Bauer J, Loh KP, Norton S, Duberstein P, Kamen C, Gilmore N, Gudina A, Kleckner A, Mohile S, Epstein RM. Older adults with advanced cancer are selective in sharing and seeking information with social networks. Patient Educ Couns. 2022 Oct;105(10):3116-3122. doi: 10.1016/j.pec.2022.06.005. Epub 2022 Jun 9.
PubMed 35717349Yu V, Yilmaz S, Freitag J, Loh KP, Kehoe L, Digiovanni G, Bauer J, Sanapala C, Epstein RM, Yousefi-Nooraie R, Mohile S. The role of social networks in prognostic understanding of older adults with advanced cancer. Patient Educ Couns. 2023 Jan;106:135-141. doi: 10.1016/j.pec.2022.10.009. Epub 2022 Oct 15.
PubMed 36270857
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer
- ClinicalTrials.gov ID
- NCT07393529
- Acronym / sponsor ID
- SONATA 2 / UOCPC26005
- Keywords
- geriatric oncology, social networks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Feb 2026 (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.
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.
Detailed description
Older adults (aged ≥65) with advanced cancer are living longer due to more effective treatments, but their median survival remains around one year. We have shown that this population experiences a high prevalence of aging-related conditions, including functional and cognitive impairments, as well as depressive and anxiety symptoms. These conditions heighten their vulnerability to treatment toxicities and increase their need for assistance with daily activities. Together, these challenges impair older adults' ability to manage their care (patient activation) and reduce their overall quality of life (QoL). Therefore, interventions are needed to increase patient activation and improve QoL in this vulnerable population.
Fostering supportive social networks (SNs) can help older adults navigate the burden of cancer and its treatments. SNs comprise individuals (e.g., family members and friends) connected by interpersonal relationships. SN members offer a range of support, including instrumental, emotional, and informational support. They play pivotal roles in clinical settings, particularly for older individuals with functional impairments. SN members attend clinic visits and advocate for patients, ensuring accurate exchange and filtering of information to align with patients' preferences. SN members also shape patients' identities, coping strategies, and disease understanding. The role of SNs becomes more prominent as older adults become more ill.
The SOcial Networks to Activate Teamwork \& Alliance (SONATA) intervention was designed to harness the SNs to provide support to older adults with advanced cancer and increase patient activation and improve QoL. The objective of this study is to conduct a pilot randomized controlled trial assessing SONATA compared to enhanced usual care among 70 older adults with advanced cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SONATA Intervention | Experimental | Behavioral: SONATAFollowing randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks. |
| Enhanced Usual Care | No intervention | –Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
- Age ≥18 years
Key exclusion criteria (4 listed)
- Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
- Unwilling to complete study procedures
- Social Network Members (if available, for intervention arm only)
- Unwilling to complete study procedures
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 |
|---|---|---|
| SONATASONATA 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. | Behavioural | SONATA Intervention |
Primary outcome
Study feasibility
Time frame: From baseline to week 16
Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
4 secondary outcomes
Emotional, social, and existential quality of life
Time frame: From baseline to week 16
Patient Activation
Time frame: From baseline to week 16.
Autonomy, Competence, and Relatedness
Time frame: From baseline to week 16
Social Support
Time frame: From baseline to week 16
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 7 Jul 2026.
- Background: PubMed 35717349Kehoe L, Sanapala C, DiGiovanni G, Yousefi-Nooraie R, Yilmaz S, Bauer J, Loh KP, Norton S, Duberstein P, Kamen C, Gilmore N, Gudina A, Kleckner A, Mohile S, Epstein RM. Older adults with advanced cancer are selective in sharing and seeking information with social networks. Patient Educ Couns. 2022 Oct;105(10):3116-3122. doi: 10.1016/j.pec.2022.06.005. Epub 2022 Jun 9.
- Background: PubMed 36270857Yu V, Yilmaz S, Freitag J, Loh KP, Kehoe L, Digiovanni G, Bauer J, Sanapala C, Epstein RM, Yousefi-Nooraie R, Mohile S. The role of social networks in prognostic understanding of older adults with advanced cancer. Patient Educ Couns. 2023 Jan;106:135-141. doi: 10.1016/j.pec.2022.10.009. Epub 2022 Oct 15.
- Individual participant dataSharing planned: Yes. Permission will also be asked on the consent form for the use of patient and social network (SN) data for future research not described in this consent. In addition, permission will be asked from patients and SN members to share de-identified transcripts from recordings for future research not described in the consent.
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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 Advanced Cancer and Older Adults (65 Years and Older), 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 4 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 7 Jul 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?
Study feasibility (time frame: From baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07393529, which also lists 2 linked publications.
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 7 Jul 2026.