Interventions to Decrease Financial Toxicity

NCT05939440 | Completed

• 1 other identifier: UAB2198
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Financial distress affects 30-70% of cancer patients and describes the burden that patients experience due to the costs of care (CoC). One reason may be because patients lack the appropriate information on CoC that would help them better plan for and manage their CoC. Therefore, the investigators plan to test a Proactive CoC intervention which includes a discussion with a trained educator on CoC information and a Cost Tracking tool to help patients deal with their CoC.

Conditions

Cancer, Breast; Cancer Colorectal; Cancer, Ovarian; Cervical Cancer; Uterine Cancer; Vulvar Cancer

Keywords

financial toxicity; financial distress; costs of care

Outcome Measures

Primary Outcomes (2)

• Financial Distress

  FD measured using the Comprehensive Score for Financial Toxicity (COST) (12 items) The score ranges from 0 to 44 with lower scores indicating worse financial distress. A Score \<26 indicates financial distress is present.

  Baseline

• Financial Distress

  FD measured using the Comprehensive Score for Financial Toxicity (COST) (12 items). The score ranges from 0 to 44 with lower scores indicating worse financial distress. A Score \<26 indicates financial distress is present.

  6 months

Secondary Outcomes (8)

• Self Efficacy

  Baseline

• Self Efficacy

  6 months

• Depression

  Baseline

• Depression

  6 months

• Anxiety

  Baseline

Other Outcomes (4)

• Health Insurance Literacy

  Baseline

• Health Insurance Literacy

  6 months

• Health Insurance Knowledge

  Baseline

Study Arms (2)

Proactive Cost of Care (P-COC) intervention

EXPERIMENTAL

One time session with trained educator to review: 1. Cost Information Flyer: Anticipated out of pocket costs flyer by cancer type and stage 2. Cost Tracking workbook: Out-of-pocket cost tracker Participants also review a "Insurance, Employment, and Financial Assistance flyer" Participants will be reminded to track their costs once a month through an automated text message or e-mail based on patient preference. Participants also receive an existing patient pamphlet "Patient and Family Guide"

Other: Proactive Cost of Care (P-COC) intervention

Usual Care

ACTIVE COMPARATOR

Participants receive an existing patient pamphlet "Patient and Family Guide"

Other: Usual Care

Interventions

Proactive Cost of Care (P-COC) intervention OTHER

As in Arm description

Proactive Cost of Care (P-COC) intervention

Usual Care OTHER

As in Arm description

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed ovarian cancer (i.e., stage II-IV epithelial histology receiving surgery and chemotherapy), or newly diagnosed cervical cancer (i.e., locally advanced stage IB3-IVA receiving chemoradiation), or newly diagnosed uterine cancer (i.e., high-risk histology likely to receive chemotherapy; serous/clear cell), or newly diagnosed stage I-III breast cancer (i.e., high-risk histology), or newly diagnosed stage III-IV Colorectal Cancer
• Receiving systemic therapy or radiation at University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
• With health insurance coverage
• With reliable access to a phone, mobile device, or Internet

You may not qualify if:

• Unable to read English
• Does not agree to complete surveys

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• O'Neal Comprehensive Cancer Center at UAB: collaborator

Study Sites (1)

O'Neal Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms; Vulvar Neoplasms; Financial Stress

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Uterine Diseases; Vulvar Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Maria Pisu, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who conduct surveys are blind to study assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled prospective trial

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 11, 2023
• Study Start: June 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: May 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)