Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT07281287

Conditions

Oncology

Financial Toxicity

Counseling

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Financial navigation

Study Details

Brief summary:

The purpose of this study is to understand the implementation and impact of a pragmatically-delivered oncology financial navigation program. The main questions it aims to answer are:

1. How did oncology financial navigation implementation strategies affect implementation outcomes?
2. What is the impact of financial navigation on patient financial hardship, quality of life, and psychological distress?
3. How were implementation strategies utilized to overcome barriers to oncology financial navigation?

Researchers will examine secondary, standard-of-care collected, patient-reported data, electronic medical record data, and qualitative interview data to answer these questions.

Conditions

Oncology

Financial Toxicity

Counseling

Study ID

NCT07281287

Start date

Feb 1, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Aim 1:

Inclusion criteria: As oncology financial navigation will be implemented as standard of care, implementation outcomes will be evaluated for:

1. All patients with cancer seen at the University of Alabama at Birmingham (UAB) Medical Oncology clinic
2. UAB oncology financial navigators

Exclusion criteria: None.

Aim 2:

Inclusion criteria: This will be a secondary data analysis of patient-reported data routinely collected since 2020, which will include:

1. Patients with cancer seen at the UAB Medical Oncology clinic
2. Patients with non-missing patient-reported outcome data

Exclusion criteria: None.

Aim 3:

Inclusion criteria:

1. Patients who have received oncology financial navigation
2. Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program
3. Health system team members (billing specialists, cancer service line leadership) involved with the oncology financial navigation program

Exclusion criteria: None.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Patients receiving standard-of-care-delivered financial navigation

no intervention: Historical control patients who did not receive financial navigation

Interventions

Financial navigation

Oncology financial navigation is an evidence-based intervention which helps patients prepare for out-of-pocket treatment costs, optimize health insurance, and access financial resources to reduce cancer-related financial hardship.

Primary outcome measure

  • Change in financial hardship [ Time Frame: 6 months post-initiation of systemic therapy ]
  • Change in financial difficulties [ Time Frame: 6 months post-initiation of systemic therapy ]
  • Change in quality of life [ Time Frame: 6 months post-initiation of systemic therapy ]
  • Change in psychological distress [ Time Frame: 6 months post-initiation of systemic therapy ]
  • Utilization of implementation strategies [ Time Frame: Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years ]
  • Patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies [ Time Frame: Annually through study completion, an average of 4 years ]

Central Contacts and Locations

Central contacts

Hayden Reeves, BS

205-996-4109haydenreeves@uabmc.edu

Courtney Williams, DrPH

205-975-0462courtneywilliams@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Hayden Reeves, BS

205-996-4109haydenreeves@uabmc.edu

Courtney Williams, DrPH

205-975-0462courtneywilliams@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 24, 2026

Last verified

Jan, 2026

Keywords

  • Financial Navigation
  • Out of pocket cost
  • Oncology
  • oncology Financial hardship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-24.