Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors (FinFit Aim 1)
March 2, 2026 updated by: Wake Forest University Health Sciences
Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors: Efficacy and Implementation of a Multilevel Intervention in Community-Based Oncology Practices
This study seeks to develop, test, and revise an intervention designed to address financial hardship (FinFit) among adolescent and young adult (AYA) cancer survivors.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To synthesize CHAT and LIFT to create FinFit, an intervention to address the unique, multilevel determinants of financial hardship among AYAs treated in community oncology practices.
OUTLINE: This is an observational study.
STEP 1: CHAT participants complete an in-depth interview on study.
STEP 2: LIFT participants complete a focus group or an interview on study.
STEP 3: Participants from steps 1 and 2 complete member-checking processes on study.
Study Type
Observational
Enrollment (Actual)
16
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
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Comprehensive Cancer
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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
N/A
Sampling Method
Non-Probability Sample
Study Population
Adults with perspectives on CHAT, LIFT, and FinFit's proposed forms as well as individuals from any community-based practice that were originally part of CHAT or LIFT administration
Description
Inclusion Criteria:
- Adults (ages 18 years of age or older) with perspectives on CHAT, LIFT, FinFit's proposed forms, and those from any community-based practices that were originally part of CHAT or LIFT administration are eligible for inclusion in Aim 1 interviews.
Exclusion Criteria:
- Those not involved in any of the preliminary programs, not familiar with the proposed forms of FinFit, or not involved in the proposed implementation sites will not be eligible for participation.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational step 1
CHAT participants complete an in-depth interview on study.
|
CHAT is a virtually delivered patient-level intervention designed to improve health insurance and cost-related literacy
Based on the findings from Steps 1 and 2, investigators will develop a document that outlines the points of overlap, harmony, or conflict identified by participants.
|
|
Observational step 2
LIFT participants complete a focus group or interview on study.
|
Based on the findings from Steps 1 and 2, investigators will develop a document that outlines the points of overlap, harmony, or conflict identified by participants.
LIFT (Lessening the Impact of Financial Toxicity), an intervention developed to coordinate access to existing financial assistance programs.
|
|
Observational step 3
Participants from steps 1 and 2 complete member-checking processes on study.
|
Based on the findings from Steps 1 and 2, investigators will develop a document that outlines the points of overlap, harmony, or conflict identified by participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Combining Data Collection from Steps 1 and 2 for the Creation of FinFit Intervention Protocol
Time Frame: Up to 12 months
|
Through the analysis of secondary outcomes (CHAT Core Functions - Step 1 LIFT Core Functions - Step 2) to develop, test, and revise an intervention designed to address financial hardship among adolescent and young adults using semi-structured interview data and analysis for the creation of protocol intervention including when, how and to whom the intervention should be delivered to.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHAT Core Functions - Step 1
Time Frame: Up to 12 months
|
Investigators will use ATLAS.ti,
multifunctional qualitative data analysis software, to apply a codebook informed by the Model for Adaptation Design and Impact, and identify themes related to CHAT's core functions.
Finally, we will use report-back sessions with interview participants to refine themes.
|
Up to 12 months
|
|
LIFT Core Functions - Step 2
Time Frame: Up to 12 months
|
Investigators will use ATLAS.ti,
multifunctional qualitative data analysis software to apply grounded theory to analyze updates to existing LIFT core functions to apply a codebook informed by the Model for Adaptation Design and Impact, and identify themes related to CHAT's core functions and points of potential overlap, harmony, or conflict with LIFT's and CHAT's core functions using a 90-120 minute focus group to review previously identified core functions.
|
Up to 12 months
|
|
Member Checking Process - Step 3
Time Frame: Up to 12 months
|
Based on the findings from Steps 1 and 2, a document that outlines the points of overlap, harmony, or conflict identified by participants will be developed.
Investigators will send this document back to all of the previous participants in a member-checking process, that will occur both virtually and asynchronously, to ensure the document reflects their perspectives.
Once this document is finalized, investigators will draft the protocol for FinFit.
Once drafted this document will be sent to all previous participants in a member-checking exercise for review and comment to ensure that it reflects their perspectives.
The Model for Adaptation Design and Impact (MADI) tool will be used to evaluate potential points of overlap, harmony or conflict between the LIFT and CHAT steps to finally assess for potential influence on implementation outcomes (e.g.
feasibility, acceptability) and FinFit outcomes (e.g., financial hardship).
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John Salsman, PhD, Wake Forest Baptist Comprehensive Cancer Center
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)
November 4, 2024
Primary Completion (Actual)
September 5, 2025
Study Completion (Actual)
September 5, 2025
Study Registration Dates
First Submitted
March 11, 2025
First Submitted That Met QC Criteria
March 17, 2025
First Posted (Actual)
March 18, 2025
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00107846
- ONC-CCS-2410 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)
- R01CA282653 (U.S. NIH Grant/Contract)
- NCI-2025-01608 (Other Identifier: CTRP)
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.