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| ID | Type | Description | Link |
|---|---|---|---|
| U19CA291430 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is a multi-site randomized trial to study the implementation of the CARE Tool and evaluate the CARE Tool. The CARE Tool is a web-based tool that gives people information about cancer care costs, health insurance, and resources to help with costs. Overall, the study aims to help patients with cancer overcome barriers they face navigating insurance and accessing financial resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Patients - Care Tool (Intervention) | Experimental | Patients will review the web-based CARE Tool after enrollment. Patients will complete a survey immediately after reviewing the website and a 3 month follow-up survey. |
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| Arm 2: Patients - Standard of care financial education information (Control) | Active Comparator | Patients will review standard web-based financial education information after enrollment. Patients will complete a survey immediately after reviewing the website and a 3 month follow up survey. |
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| Arm 3: Implementation champions - CARE training | Experimental | Participants who are members of the care team and have been identified as implementation champions will complete training on the CARE Tool and cost conversations. Participants will complete a survey after the training and a post-recruitment survey at the end of the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial education information | Other | Standard financial education resources will be provided to patients enrolled in the control arm. Financial education will be accessible via website and provided by the participating site. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's comprehensive score for financial toxicity (COST) | COST will be calculated by the sum of 11-items according to the validated measure. The items are scored on a 5-point Likert scale as follows: 0-Not at all, 1-A little bit, 2-Somewhat, 3-Quite a bit, and 4-Very much. Total possible range is 0-44 and the lower the score indicates greater financial toxicity. Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test. | Completion of initial survey to completion of follow up survey (total estimated time is 3 months) |
| Patient's score of self-efficacy for communicating about care costs measured with the Decision Self-Efficacy Scale | The measure of self-efficacy for communicating about care costs is adapted from the validated tool Decision Self-Efficacy Scale. The Decision Self-Efficacy Scale measures self-confidence or belief in one's abilities in decision making, including shared decision making. Three-items from the Decision Self-Efficacy Scale will be used to measure self-efficacy for communicating about care costs. The three items will be measured by a 3-point Likert scale as follows: 0-Not Confident, 2-A Little Confident, and 4-A lot confident. A higher score indicates greater self-efficacy in decision making. The total score will be calculated according to the validated measure. Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test. | Completion of initial survey to completion of follow up survey (total estimated time is 3 months) |
| Patient's health insurance literacy measure (HILM) score | HILM score is calculated from a 6-item questionnaire according to the validated measure. Each item is measured by a 4-point Likert scale as follows: 1-Not at all confident, 2-Slightly confident, 3-Moderately confident, and 4-Very confident. Total possible range is 0-100 where 0 represents the lowest possible health insurance literacy level (more difficulty navigating insurance) and 100 represents the highest (more confidence in choosing/using insurance). Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's reported adherence to therapy & delayed care | Patient reported delayed care will be calculated from responses to three-items adapted from the National Health Interview Survey (NHIS). The three items have four categorical answers: Yes, No, I don't know, and Prefer not to answer. Scores will be summarized using frequencies. Changes between timepoints will be analyzed using sample proportions and 95% Clopper-Pearson Confidence Intervals. Changes between timepoints will be analyzed by a Pearson Chi-square test. . |
| Measure | Description | Time Frame |
|---|---|---|
| Organizational Readiness-Adapted | Organizational readiness will be assessed by implementation champions' response to 6 items adapted from the MORE measure for organizational readiness and 3 items adapted from the organizational readiness for implementing change (ORIC) measure. MORE items are measured on a 4-point Likert scale: 1-Not willing, 2-Somewhat willing, 3-Willing, and 4-Very willing. A higher score indicates greater organizational readiness. ORIC items are measured on a 5-point Likert scale: 1-Disagree, 2-Somewhat Disagree, 3-Neither agree nor Disagree, 4-Somewhat Agree, or 5-Agree. A higher score indicates greater organizational readiness to implement change. Changes between surveys will be analyzed by a two-sample t-test. |
Inclusion Criteria for Implementation champions:
- Members of the cancer care team (e.g., physicians, nurses, research coordinators, financial navigators, social workers) that work with patients receiving treatment for gynecologic, lung, prostate, or colorectal cancer; or members of the billing team and employee of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
Exclusion Criteria for Implementation champions:
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Housten, OTD, MSCI, OTR/L | Contact | 314-454-7958 | ahousten@wustl.edu | |
| Krista Cooksey, BA | Contact | 314-935-7234 | kcooksey@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashley Housten, OTD, MSCI, OTR/L | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alton Memorial Hospital | Recruiting | Alton | Illinois | 62002 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Participants can share their data for future research. Data such as age, sex, gender identity, race, and ethnicity, will be redacted to strip identifiers and minimize risks of unauthorized disclosure of personal identifiers.
Common data elements (CDEs), identified by NCI and the ACCERT sites, will include identifiable information like zip code and county. Data from this optional survey could identify participants and may be shared with the NCI and ACCERT study teams .
Publicly available documentation will include the study protocol, survey questions, codebook, univariate statistics, and study-level metadata. The codebook will include a description of each variable with the question number and text, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," or prefer not to answer. We may share algorithms produced for analysis of CDEs.
Users must agree to the conditions of use governing access to the data.
Final submission and deposit of the study data will occur at the end of data collection. Study data deposited will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
Researchers within the ACCERT consortium and those who provide a methodologically sound plan.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| ID | Term |
|---|---|
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Patient participants will be randomized to one of two arms, the CARE Tool or standard financial education information, and participate in surveys. Participants enrolled as site staff and members of the care team will complete a training on the CARE Tool and participate in surveys.
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| CARE Tool | Other | The CARE Tool is a web-based tool provided to patients after enrollment. The CARE Tool provides patients with individualized information about cancer care costs, health insurance, and resources to assist with costs. |
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| CARE Tool Training | Other | Members of the care team who have been identified as implementation champions will undergo training on cost conversations, how to use the CARE Tool, and how to implement the CARE Tool in their clinical workflow. |
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| Completion of initial survey to completion of follow up survey (total estimated time is 3 months) |
| Completion of initial survey to completion of follow up survey (total estimated time is 3 months) |
| Feasibility of Intervention Measure (FIM) - Adapted | FIM will be assessed by implementation champions' response to a single item from the FIM measure on the initial and follow up survey. FIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater feasibility of the intervention in practice. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test. | At start of recruitment and at completion recruitment (total estimated time is 2 years) |
| Acceptability of Intervention Measure (AIM) - Adapted | AIM will be assessed by implementation champions' response to a single item from the AIM measure on the initial and follow up survey. AIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater acceptability by subjects of the intervention. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test. | At start of recruitment and at completion recruitment (total estimated time is 2 years) |
| Intervention Appropriateness Measure (IAM) - Adapted | IAM will be assessed by implementation champions' response to a single item from the IAM measure on the initial and follow up survey. IAM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater appropriateness of the intervention. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test. | At start of recruitment and at completion recruitment (total estimated time is 2 years) |
| At start of recruitment and at completion recruitment (total estimated time is 2 years) |
| Delbert Day Cancer Institute at Phelps Health | Recruiting | Rolla | Missouri | 65401 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |