Financial StressCC Links- TeleNCT07409662
Coverage and Cost of Care Links- Telehealth
A study testing CC LinksTele in people with Financial Stress and Hematologic Cancer, run by Jean Edward at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Financial Stress, Hematologic Cancer, Survivorship
- What is being tested?
- CC LinksTele
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- receiving or have received services at Danceblue clinic
- adult patient with pediatric cancer diagnosis
- caregiver of pediatric patient with cancer diagnosis
Who cannot join
- unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- CC LinksTele
- Keywords
- financial navigation, quality of life, hardship, caregivers, financial toxicity
- Medical subject headings
- Financial Stress, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC LinksTeleOther
Also called Oncology Financial and Legal Navigation
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.
| Study group | Role | What they receive |
|---|---|---|
| CC LinksTele- Patient and Caregiver | Experimental | caregivers of children with any cancer diagnosis and young adults with childhood cancers Receives: Other: CC LinksTele |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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?"
Measured: 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
Measured: 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
Measured: 8 months
Secondary outcomes (1)
Financial Savings
Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges.
Measured: Approximately at 8 months (following resolution of financial needs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start7 Mar 2024
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Financial StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Edward
- Sponsor type
- University, hospital or other
- Collaborators
- Kentucky Cabinet for Health and Family Services, Kentucky Pediatric Cancer Research Trust Fund
- Responsible party
- Sponsor-investigator, Jean Edward, University of Kentucky
- Investigators
- Jean S Edward, PhD, RN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409662
- Sponsor's protocol ID
- 85255
- Acronym
- CC Links- Tele
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edward JS, Andreae LJ, Fariduddin H, Ruschman E, Eisele L, Caldwell M, Doran J, Bryant M, Heflin J, Shelton B, D'Orazio J, Northrip KD. Evaluating the impact of virtual oncology financial and legal navigation on cancer-related financial toxicity. JNCI Cancer Spectr. 2026 Sep 3;10(5):pkag085. doi: 10.1093/jncics/pkag085.
PubMed 42636254
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coverage and Cost of Care Links- Telehealth
- ClinicalTrials.gov ID
- NCT07409662
- Acronym / sponsor ID
- CC Links- Tele / 85255
- Conditions
- Financial Stress, Hematologic Cancer, Survivorship
- Keywords
- financial navigation, quality of life, hardship, caregivers, financial toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Jean EdwardUniversity, hospital or other
- Collaborators
- Kentucky Cabinet for Health and Family Services, Kentucky Pediatric Cancer Research Trust Fund
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC LinksTele- Patient and Caregiver | Experimental | Other: CC LinksTelecaregivers of children with any cancer diagnosis and young adults with childhood cancers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- receiving or have received services at Danceblue clinic
- adult patient with pediatric cancer diagnosis
- caregiver of pediatric patient with cancer diagnosis
Key exclusion criteria (1 listed)
- unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC LinksTeleAlso: Oncology Financial and Legal NavigationStudy 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 | CC LinksTele- Patient and Caregiver |
Primary outcome
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.
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.
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.
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
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?"
Program Feasibility
Time frame: 8 months
Feasibility will be measured using the entire sample of program participants and will be defined by number enrolled
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
1 secondary outcome
Financial Savings
Time frame: Approximately at 8 months (following resolution of financial needs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 42636254Edward JS, Andreae LJ, Fariduddin H, Ruschman E, Eisele L, Caldwell M, Doran J, Bryant M, Heflin J, Shelton B, D'Orazio J, Northrip KD. Evaluating the impact of virtual oncology financial and legal navigation on cancer-related financial toxicity. JNCI Cancer Spectr. 2026 Sep 3;10(5):pkag085. doi: 10.1093/jncics/pkag085.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean S Edward, PhD, RN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC LinksTele in people with Financial Stress and Hematologic Cancer, run by Jean Edward at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Acceptability (time frame: Approximately 8 months (baseline and following resolution of financial needs)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.