NCT05829070

Brief Summary

We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. We will combine self-reported survey data with electronic health records and claims data to examine the trial outcomes and efficacy. We will also conduct an economic evaluation using cost-effectiveness and budget impact analyses, to establish the sustainability of the intervention at improving outcomes of young adult survivors through increasing their health insurance knowledge and decreasing their financial burden.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable cancer

Timeline
22mo left

Started Nov 2023

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2023Mar 2028

First Submitted

Initial submission to the registry

March 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

March 2, 2023

Last Update Submit

April 22, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (6)

  • Health Insurance Literacy Measure (HILM)

    The degree to which individuals have the knowledge, ability, and confidence to find and evaluate information about health plans, select the best plan for their own (or their family's) financial and health circumstances, and use the plan. Determined by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not all confident).

    Baseline

  • COmprehensive Score for financial Toxicity (COST)

    Financial distress related to medical costs. Determined by rating statements regarding financial distress on a 5-point scale (very much, quite a bit, somewhat, a little bit, not at all).

    Baseline

  • Health Insurance Literacy Measure

    The degree to which individuals have the knowledge, ability, and confidence to find and evaluate information about health plans, select the best plan for their own (or their family's) financial and health circumstances, and use the plan. Determined by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not all confident).

    6 months

  • COmprehensive Score for financial Toxicity (COST)

    Financial distress related to medical costs. Determined by rating statements regarding financial distress on a 5-point scale (very much, quite a bit, somewhat, a little bit, not at all).

    6 months

  • Health Insurance Literacy Measure

    The degree to which individuals have the knowledge, ability, and confidence to find and evaluate information about health plans, select the best plan for their own (or their family's) financial and health circumstances, and use the plan. Determined by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not all confident).

    12 months

  • COmprehensive Score for financial Toxicity (COST)

    Financial distress related to medical costs. Determined by rating statements regarding financial distress on a 5-point scale (very much, quite a bit, somewhat, a little bit, not at all).

    12 months

Secondary Outcomes (14)

  • Surveillance for Recurrence

    18 months

  • Survivorship Care Receipt

    18 months

  • Insurance Coverage

    Baseline

  • Insurance Coverage

    6 months

  • Insurance Coverage

    12 months

  • +9 more secondary outcomes

Study Arms (2)

CHAT-S

EXPERIMENTAL

CHAT-S consists of 4 bi-weekly 35-45 minute videoconferencing sessions with a patient navigator and a patient booklet on insurance, costs, and survivorship care.

Behavioral: CHAT-S

Usual Care

PLACEBO COMPARATOR

Usual care will consist of a resource list sent by the navigator.

Behavioral: Usual Care

Interventions

CHAT-SBEHAVIORAL

The CHAT-S intervention will include 4 videoconference sessions over a 2-month time period that is delivered by a patient navigator. Session 1 will include content to educate participants about survivorship care and common types of follow-up care required for their specific cancer, as well as, basic insurance terms and concepts. Session 2 will teach participants about their own insurance plan (e.g., coverage, benefits, breakdown of bills, and explanation of benefits) so they can better navigate both the medical and insurance systems. Session 3 reviews health insurance laws (e.g., ACA, FMLA, No Surprises Act) and how to proceed with an appeals process. Session 4 explains how to manage the costs through budgeting and cost-of-care conversations with their medical providers.

CHAT-S
Usual CareBEHAVIORAL

Usual care will consist of a resource list that describes organizational and community resources available on insurance, financial burden, and survivorship care. Further, we will track whether participants were referred or engaged in services using the follow-up surveys and via the EHR/claims data.

Usual Care

Eligibility Criteria

Age26 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants are eligible for this study if they:
  • Were diagnosed with breast, testicular, lymphoma, sarcoma, and colorectal cancer,
  • Are between the ages of 26 to 45 years (preferably between 26-39, but no older than 45),
  • Have completed initial treatment (i.e., radiation, chemotherapy, or surgery) within the past year,
  • Are a patient at the University of Utah/Huntsman Cancer Institute or Intermountain Healthcare, and
  • Speak English.

You may not qualify if:

  • Potential participants will be excluded if they:
  • Are unable to participate due to developmental delay, and
  • Speak a language other than English, and
  • Unable to participate through either phone or a video capable computer or mobile device (e.g., smartphone, laptop, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Amy Chevrier, BS

CONTACT

8018881803amy.chevrier@hci.utah.edu

Cindy Turner, MPH

CONTACT

Cindy.Turner@hci.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics

Study Record Dates

First Submitted

March 2, 2023

First Posted

April 25, 2023

Study Start

November 8, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

US(2)