ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Allison Iwan
- Phone Number: 612-626-4816
- Email: iwanx003@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: ConnectedNest adults
adults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive ConnectedNest
|
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.
|
|
Active Comparator: Standard of care adults
adults undergoing active cancer therapy or in cancer survivorship seen in multi-site oncology practices randomized to receive standard of care
|
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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 90
|
|
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.
|
Day 90
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number of Connections With Social and Community Services
Time Frame: Day 90
|
Change in the number of reported connections with social and community services from baseline (time of randomization) to day 90 after enrollment
|
Day 90
|
|
Change in Distress as Assessed by the NCCN Distress Thermometer
Time Frame: Day 90
|
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
|
Day 90
|
|
Change in Satisfaction With Care as Assessed by the Patient Satisfaction Questionnaire
Time Frame: Day 90
|
Change in self-reported satisfaction with care from baseline (time of randomization) to day 90 after enrollment using the Patient Satisfaction Questionnaire
|
Day 90
|
|
Change in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General
Time Frame: Day 90
|
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
|
Day 90
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Helen Parsons, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2024LS102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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