Clinical trial NCT05939440: Interventions to Decrease Financial Toxicity
Official title: Proactive Costs of Care Interventions to Decrease Financial Toxicity in Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Cancer Colorectal
Cancer, Ovarian
Cervical Cancer
Uterine Cancer
Vulvar Cancer
Keywords: financial toxicity
financial distress
costs of care
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: O'Neal Comprehensive Cancer Center at UAB
First posted: 2023-07-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled prospective trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The investigators will recruit 60 patients diagnosed with gynecologic (ovarian, uterine, cervical, or vulvar cancer), breast or colorectal cancer who are starting a new line of treatment at the O'Neal Comprehensive Cancer Center. Participants will be randomized to Proactive CoC intervention versus Usual Care. Usual Care consists of the current care processes at the cancer center where information on CoC and financial assistance are only provided once a financial need is identified. The main goal is to compare the change in financial distress from baseline to 6 months to see if patients who received any of the Proactive CoC intervention have improved financial distress compared to those in Usual Care.

All participants will complete two main surveys at 0 and 6 months that will ask questions to measure the study outcomes, self-efficacy (patient reported confidence managing certain situations, such as dealing with CoC), depression, anxiety, and insurance knowledge. Participants randomized to any of the Proactive CoC intervention groups will complete three additional phone interviews at 2, 4, and 6 months to check how participants utilized the materials, reasons why they have or have not, and what sections were helpful or not. This study is important to determine whether the Proactive CoC intervention can be successfully delivered, whether the intervention is useful to help patients decrease financial distress, and to inform the design of a future larger study that will include different cancer types and health systems.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Financial Distress
timeFrame: Baseline
measure: Financial Distress
timeFrame: 6 months
Secondary outcomes:
measure: Self Efficacy
timeFrame: Baseline
measure: Self Efficacy
timeFrame: 6 months
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 6 months
measure: Stress
timeFrame: Baseline
measure: Stress
timeFrame: 6 months
Other outcomes:
measure: Health Insurance Literacy
timeFrame: Baseline
measure: Health Insurance Literacy
timeFrame: 6 months
measure: Health Insurance Knowledge
timeFrame: Baseline
measure: Health Insurance Knowledge
timeFrame: 6 months
Locations:
city: Birmingham
country: United States
facility: O'Neal Comprehensive Cancer Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria Pisu, PhD
role: PRINCIPAL_INVESTIGATOR
References: