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Completed

NCT Number: NCT06881108

Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors

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

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Key information

Conditions

Hematopoietic Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Lymphatic System Neoplasm Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Comprehensive Cancer

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHAT Core Functions

Other

CHAT is a virtually delivered patient-level intervention designed to improve health insurance and cost-related literacy

LIFT Core Functions

Other

LIFT (Lessening the Impact of Financial Toxicity), an intervention developed to coordinate access to existing financial assistance programs.

Member-Checking Process

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors: Efficacy and Implementation of a Multilevel Intervention in Community-Based Oncology Practices

Acronym: FinFit Aim 1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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