Coverage and Cost of Care Links- Telehealth

NCT07409662 | Completed

• 1 other identifier: 85255
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Financial Stress; Hematologic Cancer; Survivorship

Keywords

financial navigation; quality of life; hardship; caregivers; financial toxicity

Outcome Measures

Primary Outcomes (7)

• Program Acceptability

  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)

• Change in psychological response (financial toxicity)

  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 health-related quality of life

  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 distress.

  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 insurance literacy

  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

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

  8 months

• Program Adherence

  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

Secondary Outcomes (1)

• Financial Savings

  Approximately at 8 months (following resolution of financial needs)

Study Arms (1)

CC LinksTele- Patient and Caregiver

EXPERIMENTAL

caregivers of children with any cancer diagnosis and young adults with childhood cancers

Other: CC LinksTele

Interventions

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.

Also known as: Oncology Financial and Legal Navigation

CC LinksTele- Patient and Caregiver

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- unable to provide consent

Sponsors & Collaborators

• Jean Edward: lead
• Kentucky Cabinet for Health and Family Services, Kentucky Pediatric Cancer Research Trust Fund: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Financial Stress; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jean S Edward, PhD, RN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: March 7, 2024
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)