Gynecologic CancerNCT04314284
Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
A study testing I Can PIC, Post-intervention survey (I Can PIC participants) and Follow-Up survey (I Can PIC participants) in people with Gynecologic Cancer and Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- I Can PIC, Post-intervention survey (I Can PIC participants) and Follow-Up survey (I Can PIC participants)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2020to 4 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older
- Must have been diagnosed with colorectal cancer, lung cancer, or gynecologic cancer < 5 months ago and be patients of one of the 15 providers
- This cancer diagnosis must be the first and primary diagnosis
Who cannot join
- Not able to read and understand English
- Cannot give informed consent due to cognitive or emotional barriers
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately reduce cancer patients' financial toxicity associated with cancer care.
- Conditions
- Gynecologic Cancer, Colorectal Cancer, Lung Cancer
- Being tested
- I Can PIC, Historical control survey, Post-intervention survey (I Can PIC participants), Follow-Up survey (I Can PIC participants)
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I Can PICBehavioural
-Online decision tool that explains health insurance terms and health insurance terms, provides tips on lowering health care costs, advises patient to discuss costs with provider and insurance, and provides financial resources for patient.
Historical control surveyOther
-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data.
Post-intervention survey (I Can PIC participants)Other
-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data.
Follow-Up survey (I Can PIC participants)Other
-19 questions including overall experience with cancer care provider, discussion with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, and confidence in health care choices and health insurance choices.
| Study group | Role | What they receive |
|---|---|---|
| Historical Control Survey | Other | -The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs. Receives: Other: Historical control survey |
| I Can PIC | Experimental | -Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone. Receives: Behavioral: I Can PIC; Other: Post-intervention survey (I Can PIC participants); Other: Follow-Up survey (I Can PIC participants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm
- Health insurance knowledge will be collected on the historical control survey and the I Can PIC post-intervention survey
- Score from 0% (worst) to 100% (best). Higher scores indicate greater health insurance knowledge
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm
- Health insurance literacy will be collected on the historical control survey and the I Can PIC post-intervention survey
- Score from 12 (worst) to 48 (best). Higher scores indicate greater health insurance literacy
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm
- Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
- Score either no (did not discuss health care costs with clinician) or yes (discussed one more cost-related topics with clinicians)
- Also score the number of cost-related topics discussed, if yes
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm
- Confidence communicating about health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
- Score from 4 (worst) to 16 (best). Higher scores indicate greater confidence communicating about care costs
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm
- Financial toxicity will be collected on the historical control survey and the I Can PIC post-intervention survey
- Score from 0 (best) to 44 (worst). Higher scores indicate greater financial toxicity
Measured: Completion of survey (estimated to be Day 1 for historical control participants and estimated to be Day 14 for I Can PIC participants)
Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs
- Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
- Score either no (did not refer to resources) or yes (referred to resources)
- Also score the number of cost-related topics discussed, if yes
Measured: Completion of survey (estimated to be approximately 1-14 days after enrollment)]
Secondary outcomes (4)
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
- Sustained Health insurance knowledge will be collected on the post-intervention survey and the 3-6 month follow-up survey
- Score from 0% (worst) to 100% (best). Higher scores indicate greater health insurance knowledge
Measured: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
- Sustained Health insurance literacy will be collected on the post-intervention survey and the 3-6 month follow-up survey
- Score from 12 (worst) to 48 (best). Higher scores indicate greater health insurance literacy
Measured: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
- Confidence communicating about health care costs will be collected on the post-intervention survey and the 3-6 month follow-up survey
- Score from 4 (worst) to 16 (best). Higher scores indicate greater confidence communicating about care costs
Measured: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Sustained Financial Toxicity (I Can PIC Arm)
- Sustained Financial toxicity will be collected on the post-intervention survey and the 3-6 month follow-up survey
- Score from 0 (best) to 44 (worst). Higher scores indicate greater financial toxicity
Measured: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start26 May 2020
- Primary completion27 Aug 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
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
- Mary Politi, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314284
- Sponsor's protocol ID
- 202003033
- Other IDs
- 1P50CA244431-01
- Status last verified
- May 2023
- First submitted
- 16 Mar 2020
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
- ClinicalTrials.gov ID
- NCT04314284
- Acronym / sponsor ID
- 202003033
- Conditions
- Gynecologic Cancer, Colorectal Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 May 2020 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 13 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately reduce cancer patients' financial toxicity associated with cancer care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical Control Survey | Other | Other: Historical control survey-The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs. |
| I Can PIC | Experimental | Behavioral: I Can PIC, Other: Post-intervention survey (I Can PIC participants), Other: Follow-Up survey (I Can PIC participants)-Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Must have been diagnosed with colorectal cancer, lung cancer, or gynecologic cancer < 5 months ago and be patients of one of the 15 providers
- This cancer diagnosis must be the first and primary diagnosis
Key exclusion criteria (2 listed)
- Not able to read and understand English
- Cannot give informed consent due to cognitive or emotional barriers
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 |
|---|---|---|
| I Can PIC-Online decision tool that explains health insurance terms and health insurance terms, provides tips on lowering health care costs, advises patient to discuss costs with provider and insurance, and provides financial resources for patient. | Behavioural | I Can PIC |
| Historical control survey-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data. | Other | Historical Control Survey |
| Post-intervention survey (I Can PIC participants)-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data. | Other | I Can PIC |
| Follow-Up survey (I Can PIC participants)-19 questions including overall experience with cancer care provider, discussion with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, and confidence in health care choices and health insurance choices. | Other | I Can PIC |
Primary outcome
Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
* Health insurance knowledge will be collected on the historical control survey and the I Can PIC post-intervention survey * Score from 0% (worst) to 100% (best). Higher scores indicate greater health insurance knowledge
Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
* Health insurance literacy will be collected on the historical control survey and the I Can PIC post-intervention survey * Score from 12 (worst) to 48 (best). Higher scores indicate greater health insurance literacy
Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
* Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey * Score either no (did not discuss health care costs with clinician) or yes (discussed one more cost-related topics with clinicians) * Also score the number of cost-related topics discussed, if yes
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
* Confidence communicating about health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey * Score from 4 (worst) to 16 (best). Higher scores indicate greater confidence communicating about care costs
Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm
Time frame: Completion of survey (estimated to be Day 1 for historical control participants and estimated to be Day 14 for I Can PIC participants)
* Financial toxicity will be collected on the historical control survey and the I Can PIC post-intervention survey * Score from 0 (best) to 44 (worst). Higher scores indicate greater financial toxicity
Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs
Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)]
* Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey * Score either no (did not refer to resources) or yes (referred to resources) * Also score the number of cost-related topics discussed, if yes
4 secondary outcomes
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Sustained Financial Toxicity (I Can PIC Arm)
Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mary Politi, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I Can PIC, Post-intervention survey (I Can PIC participants) and Follow-Up survey (I Can PIC participants) in people with Gynecologic Cancer and Colorectal Cancer, run by Washington University School of Medicine at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm (time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)). The study lists 9 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 9 May 2023.