- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724041
Feasibility of a Real-world, Financial Psycho-oncology Intervention to Address Cancer-related Financial Distress
The goal of this pilot, feasibility study is to evaluate the feasibility and preliminary impact of a finance-specific psycho-oncology intervention, as well as to explore perceptions of and experiences with this financial psycho-oncology intervention for patients with cancer experiencing financial hardship. The main questions it aims to answer are:
- Is this financial psycho-oncology intervention feasible, acceptable, and appropriate for patients with cancer experiencing financial hardship?
- How can we refine the financial psycho-oncology intervention to best address financial distress for patients with cancer experiencing financial hardship?
Patients enrolled in the intervention will receive 2, 60-minute long, finance-specific psycho-oncology sessions per month over the course of 3 months, for a total of 6 sessions over the course of the intervention. Patients will complete surveys during intervention enrollment and after intervention completion to assess secondary outcomes of financial hardship, psychological distress, stress, and anxiety. Individuals who consent to the financial psycho-oncology intervention will also be invited to participate in a 30-minute semi-structured interview to explore their perceptions of and experiences with the financial psycho-oncology intervention, including concepts of participation and engagement, relevance and acceptability, content and understanding, logistics and practicality, and potential impact.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hayden Reeves
- Phone Number: 205-996-4109
- Email: haydenreeves@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
Contact:
- Hayden Reeves
- Phone Number: 205-996-4109
- Email: haydenreeves@uabmc.edu
-
Principal Investigator:
- Courtney Williams, DrPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients with cancer receiving treatment at the UAB Medical Oncology and/or UAB Supportive Care clinics
Exclusion Criteria:
- non-English speakers
- patients with non-melanoma skin cancers
- patients with dementia/cognitive impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients receiving financial psycho-oncology intervention
|
Program which integrates emotional support, coping strategies, and financial psychoeducation to enhance patients' capacity to cope with both their emotional and financial burdens due to cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment as a measure of feasibility
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
50% of contacted patients consenting to participate
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Retention as a measure of feasibility
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
70% of consenting patients completing the program per protocol
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Completion as a measure of feasibility
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
<15% missing survey data
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Financial hardship
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by COmprehensive Score for financial Toxicity (COST)
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Psychological distress
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by National Comprehensive Cancer Network Distress Thermometer and Problem List
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Perceived stress
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by Perceived Stress Scale (PSS-10)
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Anxiety
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by PROMIS Emotional Distress - Anxiety - Short Form 4
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Depression
Time Frame: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by PROMIS Emotional Distress - Depression - Short Form 4
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Courtney Williams, DrPH, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREP_Williams2026
- UAB (Other Identifier: UAB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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