Interventions to Decrease Financial Toxicity

Cervical Cancer Clinical Trial

— P-COC  

Official title:

Proactive Costs of Care Interventions to Decrease Financial Toxicity in Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939440
• Other study ID #: UAB2198
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: Maria Pisu, PhD
• Phone: 2059757366
• Email: mpisu[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Colorectal
• Cancer, Breast
• Cancer, Ovarian
• Cervical Cancer
• Financial Stress
• Ovarian Neoplasms
• Uterine Cancer
• Uterine Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Other:
• Proactive Cost of Care (P-COC) intervention
As in Arm description
• Usual Care
As in Arm description

Locations

Country	Name	City	State
United States	O'Neal Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	O'Neal Comprehensive Cancer Center at UAB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Insurance Literacy	Health insurance literacy measure (HILM) measures the ability for individuals to choose and use private health insurance. Given the goals of our intervention to help patients use rather than choose health insurance, questions included those assessing confidence using insurance (5 questions) and being proactive when using health insurance (4 questions). Each question is assessed on a scale from 1 (not at all confident) to 4 (very confident). Within each domain (confidence using insurance, being proactive when using health insurance), a higher score indicates more confidence or being more proactive, respectively.	Baseline
Other	Health Insurance Literacy	Health insurance literacy measure (HILM) measures the ability for individuals to choose and use private health insurance. Given the goals of our intervention to help patients use rather than choose health insurance, questions included those assessing confidence using insurance (5 questions) and being proactive when using health insurance (4 questions). Each question is assessed on a scale from 1 (not at all confident) to 4 (very confident). Within each domain (confidence using insurance, being proactive when using health insurance), a higher score indicates more confidence or being more proactive, respectively.	6 months
Other	Health Insurance Knowledge	Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.	Baseline
Other	Health Insurance Knowledge	Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.	6 months
Primary	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
Primary	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	Self Efficacy	Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale (10 items). Questions ask patients to rate their level of confidence managing situations, problems, and events related to dealing with costs of care. Responses are on a scale of 1 "I am not at all confident" to 5 "I am very confident." Self-efficacy is scored by converting raw scores into a T-score resulting in a standardized score with a mean of 50 and a standard deviation of 10.A higher score indicates more self-efficacy.	Baseline
Secondary	Self Efficacy	Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale (10 items). Questions ask patients to rate their level of confidence managing situations, problems, and events related to dealing with costs of care. Responses are on a scale of 1 "I am not at all confident" to 5 "I am very confident." Self-efficacy is scored by converting raw scores into a T-score resulting in a standardized score with a mean of 50 and a standard deviation of 10. A higher score indicates more self-efficacy.	6 months
Secondary	Depression	Patient Health Questionnaire (PHQ-9). Responses range from 0 "Not at all" to 3 "Nearly every day". Cut points of 5, 10, 15, and 20 are used for mild, moderate, moderately severe, and severe depression. Investigators will dichotomize into mild vs. at least moderate depression.	Baseline
Secondary	Depression	Patient Health Questionnaire (PHQ-9). Responses range from 0 "Not at all" to 3 "Nearly every day". Cut points of 5, 10, 15, and 20 are used for mild, moderate, moderately severe, and severe depression. Investigators will dichotomize into mild vs. at least moderate depression.	6 months
Secondary	Anxiety	General Anxiety Disorder (GAD-7). Responses range from 0 "Not at all" to 3 "Nearly every day". Cut points of 5, 10, and 15 are used for mild, moderate, and severe anxiety. Responses will be dichotomized into mild vs. at least moderate anxiety.	Baseline
Secondary	Anxiety	General Anxiety Disorder (GAD-7). Responses range from 0 "Not at all" to 3 "Nearly every day". Cut points of 5, 10, and 15 are used for mild, moderate, and severe anxiety. Responses will be dichotomized into mild vs. at least moderate anxiety.	6 months
Secondary	Stress	Weekly Stress Inventory - Short Form (WSI-SF). 25-item self-report scale that measures the number of minor stressors that occur in one week. Individual items are scored on an 8-point Likert scale. Two scores are obtained, the event score (WSI-SFE), which ranges from 0-25, and the impact score (WSI-SFI), which ranges from 0-175. A higher event score indicates more stressors and a higher impact score indicates a higher impact from these stressors.	Baseline
Secondary	Stress	Weekly Stress Inventory - Short Form (WSI-SF). 25-item self-report scale that measures the number of minor stressors that occur in one week. Individual items are scored on an 8-point Likert scale. Two scores are obtained, the event score (WSI-SFE), which ranges from 0-25, and the impact score (WSI-SFI), which ranges from 0-175. A higher event score indicates more stressors and a higher impact score indicates a higher impact from these stressors.	6 months