Hematopoietic NeoplasmFinFit Aim 1NCT06881108
Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors
An observational study of Hematopoietic Neoplasm and Malignant Solid Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Neoplasm, Malignant Solid Neoplasm, Lymphatic System Neoplasm
- What is being tested?
- CHAT Core Functions, LIFT Core Functions and Member-Checking Process
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 5 Sep 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- CHAT Core Functions, LIFT Core Functions, Member-Checking Process
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAT Core FunctionsOther
CHAT is a virtually delivered patient-level intervention designed to improve health insurance and cost-related literacy
LIFT Core FunctionsOther
LIFT (Lessening the Impact of Financial Toxicity), an intervention developed to coordinate access to existing financial assistance programs.
Member-Checking ProcessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational step 1 | CHAT participants complete an in-depth interview on study. Receives: Other: CHAT Core Functions; Other: Member-Checking Process | |
| Observational step 2 | LIFT participants complete a focus group or interview on study. Receives: Other: LIFT Core Functions; Other: Member-Checking Process | |
| Observational step 3 | Participants from steps 1 and 2 complete member-checking processes on study. Receives: Other: Member-Checking Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combining Data Collection from Steps 1 and 2 for the Creation of FinFit Intervention Protocol
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.
Measured: Up to 12 months
Secondary outcomes (3)
CHAT Core Functions - Step 1
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.
Measured: Up to 12 months
LIFT Core Functions - Step 2
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.
Measured: Up to 12 months
Member Checking Process - Step 3
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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start4 Nov 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Salsman, PhD, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881108
- Sponsor's protocol ID
- IRB00107846
- Other IDs
- ONC-CCS-2410, R01CA282653, NCI-2025-01608
- Acronym
- FinFit Aim 1
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors: Efficacy and Implementation of a Multilevel Intervention in Community-Based Oncology Practices
- ClinicalTrials.gov ID
- NCT06881108
- Acronym / sponsor ID
- FinFit Aim 1 / IRB00107846
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 18 Mar 2025 (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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational step 1 | – | Other: CHAT Core Functions, Other: Member-Checking ProcessCHAT participants complete an in-depth interview on study. |
| Observational step 2 | – | Other: LIFT Core Functions, Other: Member-Checking ProcessLIFT participants complete a focus group or interview on study. |
| Observational step 3 | – | Other: Member-Checking ProcessParticipants from steps 1 and 2 complete member-checking processes on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| CHAT Core FunctionsCHAT is a virtually delivered patient-level intervention designed to improve health insurance and cost-related literacy | Other | Observational step 1 |
| LIFT Core FunctionsLIFT (Lessening the Impact of Financial Toxicity), an intervention developed to coordinate access to existing financial assistance programs. | Other | Observational step 2 |
| Member-Checking ProcessBased 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. | Other | Observational step 1, Observational step 2, Observational step 3 |
Primary outcome
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.
3 secondary outcomes
CHAT Core Functions - Step 1
Time frame: Up to 12 months
LIFT Core Functions - Step 2
Time frame: Up to 12 months
Member Checking Process - Step 3
Time frame: Up to 12 months
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 3 Mar 2026.
- 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.
John Salsman, PhD principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Neoplasm and Malignant Solid Neoplasm, run by Wake Forest University Health Sciences 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 1 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 3 Mar 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?
Combining Data Collection from Steps 1 and 2 for the Creation of FinFit Intervention Protocol (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.