NCT06559228

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2 cancer

Timeline
2mo left

Started Jun 2025

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

August 15, 2024

Last Update Submit

May 6, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Day 90

  • 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.

    Day 90

Secondary Outcomes (3)

  • Number of connections with needed social and community services with needed social and community services

    Day 90

  • Quality of life

    Day 90

  • Satisfaction with Care

    Day 90

Study Arms (2)

ConnectedNest adults

EXPERIMENTAL

adults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive ConnectedNest

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

Other: Standard of care

Interventions

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.

ConnectedNest adults

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

Standard of care adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Helen Parsons, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 19, 2024

Study Start

June 12, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations