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OpenTrials
Completed

NCT Number: NCT07409662

Coverage and Cost of Care Links- Telehealth

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC LinksTele

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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?"

  6. Program Feasibility

    Time frame: 8 months

    Feasibility will be measured using the entire sample of program participants and will be defined by number enrolled

  7. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Jean Edward

Other

Collaborators

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

Registry information

Acronym: CC Links- Tele

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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