Gynecologic CancerNCT07296887
CARE Tool Study Aim 3
A study testing Financial education information, CARE Tool and CARE Tool Training in people with Gynecologic Cancer and Prostate Cancer, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- Financial education information, CARE Tool and CARE Tool Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Apr 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Age 18 and over
- Primary or recurrent diagnosis of gynecologic, prostate, lung, or colorectal cancer in the last 12 months
- Receiving cancer treatment from Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
- Self-reported ability to read and speak English
Who cannot join
- Implementation champions are ineligible if they are non-employees of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
- Do not treat patients for gynecologic, prostate, lung, or colorectal cancer
- Under the age of 18
- Not diagnosed with gynecologic, prostate, lung, or colorectal cancer within the previous 12 months from recruitment
- Not receiving care at Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
- Cannot give consent due to cognitive or emotional barriers
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Alton Memorial Hospital
Alton, Illinois, 62002
Ashley Housten, OTD, MSCI, OTR/L, 314-454-7958, ahousten@wustl.edu
Ashley Housten, OTD, MSCI, OTR/L
- Recruiting
Delbert Day Cancer Institute at Phelps Health
Rolla, Missouri, 65401
Casey Burton, Ph.D., 573-458-7043, cburton@phelpshealth.org
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Ashley Housten, OTD, MSCI, OTR/L, 314-454-7958, ahousten@wustl.edu
Krista Cooksey, BA, 314-935-7234, kcooksey@wustl.edu
About this study
Official title: Implement and Evaluate the CARE Tool in a Randomized Trial
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.
- Conditions
- Gynecologic Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer
- Being tested
- Financial education information, CARE Tool, CARE Tool Training
- Keywords
- Insurance, Insurance coverage, Cancer, Cost of medical care, Financial toxicity
- Medical subject headings
- Prostatic Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial education informationOther
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.
CARE ToolOther
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.
CARE Tool TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CARE Tool |
| 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. Receives: Other: Financial education information |
| 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. Receives: Other: CARE Tool Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Secondary outcomes (4)
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. .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At start of recruitment and at completion recruitment (total estimated time is 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 Apr 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ashley Housten, OTD, MSCI, OTR/L, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296887
- Sponsor's protocol ID
- 202601127
- Other IDs
- U19CA291430
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implement and Evaluate the CARE Tool in a Randomized Trial
- ClinicalTrials.gov ID
- NCT07296887
- Acronym / sponsor ID
- 202601127
- Conditions
- Gynecologic Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer
- Keywords
- Insurance, Insurance coverage, Cancer, Cost of medical care, Financial toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Patients - Care Tool (Intervention) | Experimental | Other: CARE ToolPatients 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. |
| Arm 2: Patients - Standard of care financial education information (Control) | Active comparator | Other: Financial education informationPatients 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. |
| Arm 3: Implementation champions - CARE training | Experimental | Other: CARE Tool TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Age 18 and over
- Primary or recurrent diagnosis of gynecologic, prostate, lung, or colorectal cancer in the last 12 months
- Receiving cancer treatment from Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
- Self-reported ability to read and speak English
Key exclusion criteria (6 listed)
- Implementation champions are ineligible if they are non-employees of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
- Do not treat patients for gynecologic, prostate, lung, or colorectal cancer
- Under the age of 18
- Not diagnosed with gynecologic, prostate, lung, or colorectal cancer within the previous 12 months from recruitment
- Not receiving care at Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial education informationStandard 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. | Other | Arm 2: Patients - Standard of care financial education information (Control) |
| CARE ToolThe 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. | Other | Arm 1: Patients - Care Tool (Intervention) |
| CARE Tool TrainingMembers 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. | Other | Arm 3: Implementation champions - CARE training |
Primary outcome
Patient's comprehensive score for financial toxicity (COST)
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
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.
Patient's score of self-efficacy for communicating about care costs measured with the Decision Self-Efficacy Scale
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
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.
Patient's health insurance literacy measure (HILM) score
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
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.
4 secondary outcomes
Patient's reported adherence to therapy & delayed care
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Feasibility of Intervention Measure (FIM) - Adapted
Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)
Acceptability of Intervention Measure (AIM) - Adapted
Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)
Intervention Appropriateness Measure (IAM) - Adapted
Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Housten, OTD, MSCI, OTR/L principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial education information, CARE Tool and CARE Tool Training in people with Gynecologic Cancer and Prostate Cancer, run by Washington University School of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Housten, OTD, MSCI, OTR/L (314-454-7958, ahousten@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's comprehensive score for financial toxicity (COST) (time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.