Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors

Recruiting

• Conditions: Hematopoietic Neoplasm; Malignant Solid Neoplasm; Lymphatic System Neoplasm

• Registration Number: NCT06881108
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This study seeks to develop, test, and revise an intervention designed to address financial hardship (FinFit) among adolescent and young adult (AYA) cancer survivors.

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 Timeline

• Study Start: 2024-11-04
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combining Data Collection from Steps 1 and 2 for the Creation of FinFit Intervention Protocol	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.

Secondary Outcome Measures

Name	Time	Method
CHAT Core Functions - Step 1	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.
LIFT Core Functions - Step 2	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.
Member Checking Process - Step 3	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).

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer; 🇺🇸 Winston-Salem, North Carolina, United States