Coverage and Cost of Care Links- Telehealth (CC Links- Tele)

February 16, 2026 updated by: Jean Edward
The overall objective of this study is to develop and implement CC LinksTele (Coverage and Cost-of-Care Links- Telehealth)- a multilevel intervention designed to empower pediatric cancer patients, caregivers, and healthcare teams with the resources to reduce financial toxicity by addressing patient and caregiver financial health literacy (individual-level) and cancer care delivery pathways and workflows to address financial hardship (health system-level).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • receiving or have received services at Danceblue clinic
  • adult patient with pediatric cancer diagnosis
  • caregiver of pediatric patient with cancer diagnosis

Exclusion Criteria:

- unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CC LinksTele- Patient and Caregiver
caregivers of children with any cancer diagnosis and young adults with childhood cancers
Other: CC LinksTele
Study participants will be contacted by a TRIAGE Cancer staff member via phone and will receive one-on-one education, coaching and/or navigation of cancer-related financial and/or legal issues. These navigation sessions can take an average of 1 to 3 hours depending on the participants needs.
Other Names:
  • Oncology Financial and Legal Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in psychological response (financial toxicity)
Time Frame: Approximately 8 months (baseline and following resolution of financial needs)
Psychological response (i.e. financial toxicity) was measured using the 11-item Comprehensive Score for Financial Toxicity (COST) that measures emotional aspects of financial hardship (financial toxicity) among cancer patients. Each item is scored on a 5-point ordinal scale ranging from 0='Not at all' to 4='Very much.' Sample items include 'My out-of-pocket expense are more than I thought they would be' and 'I am frustrated that I cannot work or contribute as much as I usually do.' Lower values indicate greater financial toxicity.
Approximately 8 months (baseline and following resolution of financial needs)
Change in distress.
Time Frame: Approximately 8 months (baseline and following resolution of financial needs)
Distress was measured using the National Comprehensive Cancer Network's (NCCN) Distress Thermometer and its accompanying 40-item problem list. A cutoff score of 4 indicated clinically elevated distress levels
Approximately 8 months (baseline and following resolution of financial needs)
Change in health-related quality of life
Time Frame: Approximately 8 months (baseline and following resolution of financial needs)
Health-related QOL was measured using four Patient-Reported Outcomes Measurement Information System (PROMIS) scales.xx Each of these were scored and standardized by submitting the raw values to the HealthMeasures scoring service. standardized values of the total scores were used throughout the analysis for this study. The four scales include the PROMIS physical health and emotional health subscales (from the 10-item PROMIS Scale v1.2 - Global Health),xx the 4-item PROMIS- Anxiety Short Form, and the 6-item PROMIS-Depression Short Form. The physical (physical health, function, pain, and fatigue items) and emotional health (QOL, mental health, social activities, and emotional problem items) subscales are each based on 4 items, with higher scores indicating a more positive health self-assessment. For the anxiety and depression scales, higher scores indicate a greater manifestation of symptoms.
Approximately 8 months (baseline and following resolution of financial needs)
Change in health insurance literacy
Time Frame: Approximately 8 months (baseline and following resolution of financial needs)
single item, yes/no question "Did you ever have a problem understanding health insurance or medical bills related to your cancer, its treatment, or the lasting effects of that treatment?"
Approximately 8 months (baseline and following resolution of financial needs)
Program Feasibility
Time Frame: 8 months
Feasibility will be measured using the entire sample of program participants and will be defined by number enrolled
8 months
Program Adherence
Time Frame: 8 months
Adherence will be measured using the entire sample of program participants and will be defined by percentage of participants that maintain communication and provide required information to resolve financial issues
8 months
Program Acceptability
Time Frame: Approximately 8 months (baseline and following resolution of financial needs)
Acceptability will be measured as mean post-intervention ratings of greater than 7-10 on financial navigation program relevance, helpfulness, convenience, recommendation to others and value (0=not at all to 10=extremely). Higher scores indicate greater program acceptability.
Approximately 8 months (baseline and following resolution of financial needs)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Financial Savings
Time Frame: Approximately at 8 months (following resolution of financial needs)
Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges.
Approximately at 8 months (following resolution of financial needs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean Edward

Collaborators

Kentucky Cabinet for Health and Family Services, Kentucky Pediatric Cancer Research Trust Fund

Investigators

  • Principal Investigator: Jean S Edward, PhD, RN, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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