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Interventions to Decrease Financial Toxicity (P-COC)

Primary Purpose

Cancer, Breast, Cancer Colorectal, Cancer, Ovarian

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Cost of Care (P-COC) intervention
Usual Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast focused on measuring financial toxicity, financial distress, costs of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • O'Neal Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proactive Cost of Care (P-COC) intervention

Usual Care

Arm Description

One time session with trained educator to review: Cost Information Flyer: Anticipated out of pocket costs flyer by cancer type and stage 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"

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 9, 2023
Last Updated
June 30, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
O'Neal Comprehensive Cancer Center at UAB
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1. Study Identification

Unique Protocol Identification Number
NCT05939440
Brief Title
Interventions to Decrease Financial Toxicity
Acronym
P-COC
Official Title
Proactive Costs of Care Interventions to Decrease Financial Toxicity in Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
O'Neal Comprehensive Cancer Center at UAB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer Colorectal, Cancer, Ovarian, Cervical Cancer, Uterine Cancer, Vulvar Cancer
Keywords
financial toxicity, financial distress, costs of care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled prospective trial
Masking
Outcomes Assessor
Masking Description
Assessors who conduct surveys are blind to study assignment
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proactive Cost of Care (P-COC) intervention
Arm Type
Experimental
Arm Description
One time session with trained educator to review: Cost Information Flyer: Anticipated out of pocket costs flyer by cancer type and stage 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"
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants receive an existing patient pamphlet "Patient and Family Guide"
Intervention Type
Other
Intervention Name(s)
Proactive Cost of Care (P-COC) intervention
Intervention Description
As in Arm description
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
As in Arm description
Primary Outcome Measure Information:
Title
Financial Distress
Description
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.
Time Frame
Baseline
Title
Financial Distress
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self Efficacy
Description
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.
Time Frame
Baseline
Title
Self Efficacy
Description
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.
Time Frame
6 months
Title
Depression
Description
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.
Time Frame
Baseline
Title
Depression
Description
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.
Time Frame
6 months
Title
Anxiety
Description
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.
Time Frame
Baseline
Title
Anxiety
Description
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.
Time Frame
6 months
Title
Stress
Description
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.
Time Frame
Baseline
Title
Stress
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Health Insurance Literacy
Description
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.
Time Frame
Baseline
Title
Health Insurance Literacy
Description
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.
Time Frame
6 months
Title
Health Insurance Knowledge
Description
Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.
Time Frame
Baseline
Title
Health Insurance Knowledge
Description
Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Pisu, PhD
Phone
2059757366
Email
mpisu@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Aquila Brown-Galvan, MPH
Phone
2059341707
Email
acpbrown@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Pisu, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
O'Neal Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria M Pisu
Phone
205-975-7366
Email
mpisu@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Interventions to Decrease Financial Toxicity

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