CancerPhase 2NCT06559228
ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care
A Phase 2 study testing ConnectedNest in people with Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ConnectedNest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 18 and over
- undergoing active cancer therapy or in survivorship
- must be able to read and write in English
- Seen in a participating Minnesota oncology clinic
Who cannot join
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. With new advancements in treatment and rising out-of-pocket expenses, individuals facing cancer are especially vulnerable to the adverse effects of SDoH. To address these barriers, a novel solution is needed to support oncology patients, clinical teams, and community-based organizations (CBOs) across the cancer continuum. In a Phase I contract award, XanthosHealth developed ConnectedNest, a novel electronic social care referral platform to screen for SDoH needs and connect individuals with cancer to social and community services provided by CBOs while engaging the oncology team in the SDoH referral process. Through additional funding, a pilot study was completed in Minneapolis, Minnesota, in partnership with Minnesota Cancer Alliance, involving the collaboration of 14 CBOs focused on cancer. 50 cancer survivors from these CBOs were enrolled to utilize the ConnectedNest platform for a 90-day duration. Our study involved the collection and analysis of crucial metrics related to patient and CBO engagement, SDoH needs, and the volume of feasible social care referrals. In Phase II, the technical features and integration capabilities of ConnectedNest will be enhanced based on learnings in Phase I and completed pilot study. The platform will be implemented and tested among patients seen at multiple oncology clinics, evaluating health outcomes of patients who use the platform.
- Conditions
- Cancer
- Being tested
- ConnectedNest, Standard of care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConnectedNestOther
Participants will receive a secure message to register and download ConnectedNest's patient app, EmpowerNest. They will be asked to complete a set of modules at baseline through ConnectedNest to understand their health related social needs and programs available to meet those needs. They will receive basic training on the functionality and services available within the app and asked to use the app to identify and connect with needed social and community services for 90 days. Participants will be directed to complete a survey at baseline, 30, 60, and 90 days to collect patient-reported outcomes.
Standard of careOther
Participants will be directed to complete a survey at baseline, 30, 60 and 90 days to collect patient-reported demographics, cancer characteristics and outcomes metrics
| Study group | Role | What they receive |
|---|---|---|
| ConnectedNest adults | Experimental | adults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive ConnectedNest Receives: Other: ConnectedNest |
| Standard of care adults | Active comparator | adults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Self-Reported Social Needs
change in the number of reported social needs from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool.
Measured: Day 90
Change in Number of Reported Social Needs That Are Partially or Completely Met
change in the number of reported social needs that are partially or completely met from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool.
Measured: Day 90
Secondary outcomes (4)
Change in Number of Connections With Social and Community Services
Change in the number of reported connections with social and community services from baseline (time of randomization) to day 90 after enrollment
Measured: Day 90
Change in Distress as Assessed by the NCCN Distress Thermometer
Change in self-reported levels of distress using the National Comprehensive Cancer Network (NCCN) distress thermometer from baseline (time of randomization) to day 90 after enrollment
Measured: Day 90
Change in Satisfaction With Care as Assessed by the Patient Satisfaction Questionnaire
Change in self-reported satisfaction with care from baseline (time of randomization) to day 90 after enrollment using the Patient Satisfaction Questionnaire
Measured: Day 90
Change in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General
Change in self-reported quality of life from baseline (time of randomization) to day 90 after enrollment using the Functional Assessment of Cancer Survey-General
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start12 Jun 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
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 MinnesotaThe 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Parsons, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559228
- Sponsor's protocol ID
- 2024LS102
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care
- ClinicalTrials.gov ID
- NCT06559228
- Acronym / sponsor ID
- 2024LS102
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Aug 2024 (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.
Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. With new advancements in treatment and rising out-of-pocket expenses, individuals facing cancer are especially vulnerable to the adverse effects of SDoH. To address these barriers, a novel solution is needed to support oncology patients, clinical teams, and community-based organizations (CBOs) across the cancer continuum. In a Phase I contract award, XanthosHealth developed ConnectedNest, a novel electronic social care referral platform to screen for SDoH needs and connect individuals with cancer to social and community services provided by CBOs while engaging the oncology team in the SDoH referral process. Through additional funding, a pilot study was completed in Minneapolis, Minnesota, in partnership with Minnesota Cancer Alliance, involving the collaboration of 14 CBOs focused on cancer. 50 cancer survivors from these CBOs were enrolled to utilize the ConnectedNest platform for a 90-day duration. Our study involved the collection and analysis of crucial metrics related to patient and CBO engagement, SDoH needs, and the volume of feasible social care referrals. In Phase II, the technical features and integration capabilities of ConnectedNest will be enhanced based on learnings in Phase I and completed pilot study. The platform will be implemented and tested among patients seen at multiple oncology clinics, evaluating health outcomes of patients who use the platform.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ConnectedNest adults | Experimental | Other: ConnectedNestadults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive ConnectedNest |
| Standard of care adults | Active comparator | Other: Standard of careadults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, age 18 and over
- undergoing active cancer therapy or in survivorship
- must be able to read and write in English
- Seen in a participating Minnesota oncology clinic
Key exclusion criteria (1 listed)
- Children
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 |
|---|---|---|
| ConnectedNestParticipants will receive a secure message to register and download ConnectedNest's patient app, EmpowerNest. They will be asked to complete a set of modules at baseline through ConnectedNest to understand their health related social needs and programs available to meet those needs. They will receive basic training on the functionality and services available within the app and asked to use the app to identify and connect with needed social and community services for 90 days. Participants will be directed to complete a survey at baseline, 30, 60, and 90 days to collect patient-reported outcomes. | Other | ConnectedNest adults |
| Standard of careParticipants will be directed to complete a survey at baseline, 30, 60 and 90 days to collect patient-reported demographics, cancer characteristics and outcomes metrics | Other | Standard of care adults |
Primary outcome
Change in Number of Self-Reported Social Needs
Time frame: Day 90
change in the number of reported social needs from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool.
Change in Number of Reported Social Needs That Are Partially or Completely Met
Time frame: Day 90
change in the number of reported social needs that are partially or completely met from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool.
4 secondary outcomes
Change in Number of Connections With Social and Community Services
Time frame: Day 90
Change in Distress as Assessed by the NCCN Distress Thermometer
Time frame: Day 90
Change in Satisfaction With Care as Assessed by the Patient Satisfaction Questionnaire
Time frame: Day 90
Change in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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. This study is not recruiting at the moment.
Helen Parsons, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ConnectedNest in people with Cancer, run by University of Minnesota 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 4 inclusion and 1 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: finished, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Self-Reported Social Needs (time frame: Day 90). 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.