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Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04314284
Enrollment
150
Registered
2020-03-19
Start date
2020-05-26
Completion date
2021-11-04
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Gynecologic Cancer, Lung Cancer

Brief 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 reduce cancer patients' financial toxicity associated with cancer care.

Interventions

BEHAVIORALI 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.

OTHERHistorical 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.

OTHERPost-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.

OTHERFollow-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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligibility criteria for I Can Pic Arm only: Inclusion Criteria: * 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

Exclusion criteria

* Not able to read and understand English * Cannot give informed consent due to cognitive or emotional barriers

Design outcomes

Primary

MeasureTime frameDescription
Difference in Number of Clinicians Who Referred Patients to Resources to Discuss CostsCompletion 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
Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC ArmCompletion 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 ArmCompletion 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 Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC ArmCompletion 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 ArmCompletion 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 ArmCompletion 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 ArmCompletion 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 Health Insurance Knowledge Between Historical Control Arm and I Can PIC ArmCompletion 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 the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCompletion 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

Secondary

MeasureTime frameDescription
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)* 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
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)* 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
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)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 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
Sustained Financial Toxicity (I Can PIC Arm)Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)* 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

Other

MeasureTime frameDescription
Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)Completion of survey (estimated to be approximately 1-14 days after enrollment)* Delayed or forgone care due to costs will be collected on the historical control survey and the I Can PIC post-intervention survey * Score from 0 (best) to 8 (worst). Higher scores indicate more frequent delayed and forgone care due to costs
Delayed or Forgone Care Due to Costs (I Can PIC Arm)Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)* Delayed or forgone care due to costs will be collected on the post-intervention survey and the 3-6 month follow-up survey * Score from 0 (best) to 8 (worst). Higher scores indicate more frequent delayed and forgone care due to costs

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
68
I Can PIC
-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.
68
Total136

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyConsented but did not complete survey06
Overall StudyWithdrawal by Subject47

Baseline characteristics

CharacteristicHistorical Control SurveyTotalI Can PIC
Age, Continuous61.5 years61 years60 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
64 Participants132 Participants68 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants3 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants7 Participants3 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants3 Participants0 Participants
Race (NIH/OMB)
White
58 Participants123 Participants65 Participants
Region of Enrollment
United States
68 participants136 participants68 participants
Sex/Gender, Customized
Female
40 Participants83 Participants43 Participants
Sex/Gender, Customized
Male
25 Participants50 Participants25 Participants
Sex/Gender, Customized
Unknown
3 Participants3 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
7 / 682 / 68
other
Total, other adverse events
0 / 680 / 68
serious
Total, serious adverse events
0 / 680 / 68

Outcome results

Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

Population: 4 participants in the Historical Control Survey arm did not complete the survey.

ArmMeasureValue (MEAN)Dispersion
Historical Control SurveyDifference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm13.59 score on a scaleStandard Deviation 2.92
I Can PICDifference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm13.81 score on a scaleStandard Deviation 2.75
p-value: 0.65Kruskal-Wallis
Primary

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

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)

Population: 3 participants in the Historical Control Survey arm did not complete the survey

ArmMeasureValue (MEAN)Dispersion
Historical Control SurveyDifference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm17.71 score on a scaleStandard Deviation 11.2
I Can PICDifference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm16.06 score on a scaleStandard Deviation 9.83
p-value: 0.52Kruskal-Wallis
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

Population: 3 participants in the Historical Control Survey arm did not complete the survey.

ArmMeasureValue (MEAN)Dispersion
Historical Control SurveyDifference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm72.45 score on a scaleStandard Deviation 18.77
I Can PICDifference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm77.02 score on a scaleStandard Deviation 19.03
p-value: 0.15Kruskal-Wallis
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

Population: 3 participants in the Historical Control Survey arm did not complete the survey.

ArmMeasureValue (MEAN)Dispersion
Historical Control SurveyDifference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm33.03 score on a scaleStandard Deviation 8.56
I Can PICDifference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm34.71 score on a scaleStandard Deviation 7.65
p-value: 0.35Kruskal-Wallis
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)]

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control SurveyDifference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs11 Participants
I Can PICDifference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs14 Participants
p-value: 0.51Chi-squared
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control SurveyDifference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm32 Participants
I Can PICDifference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm33 Participants
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control SurveyDifference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm46 Participants
I Can PICDifference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm39 Participants
p-value: 0.22Chi-squared
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

ArmMeasureGroupValue (NUMBER)
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmTime off work during treatment or recovery16 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCost of over-the-counter drugs3 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCosts of getting to and from visits8 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmComparing costs of options to help choose care3 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCost of drugs to treat cancer9 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCost of day-to-day living2 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCosts of specific tests, visits, or equipment7 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmOther1 cost-related topics discussed
Historical Control SurveyDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmInsurance eligibility or coverage32 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmOther2 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmInsurance eligibility or coverage33 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmTime off work during treatment or recovery15 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCost of drugs to treat cancer11 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCosts of getting to and from visits1 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCosts of specific tests, visits, or equipment5 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCost of over-the-counter drugs6 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmComparing costs of options to help choose care0 cost-related topics discussed
I Can PICDifference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC ArmCost of day-to-day living2 cost-related topics discussed
Primary

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

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

ArmMeasureGroupValue (NUMBER)
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChoosing a generic drug instead of a brand name drug6 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting a community agency or charity2 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmCopay assistance, coupons, or rebates for drugs2 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting a free drug program1 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChange the dose (amount) of treatment7 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting talking to human resources1 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmReferring to hospital billing office8 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChoosing a lower cost procedure or scan0 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSetting up a payment plan2 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting government assistance0 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmStopping or pausing some treatments4 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmOther4 cost strategies discussed
Historical Control SurveyDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChanging logistics of care21 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmOther1 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChanging logistics of care18 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChange the dose (amount) of treatment8 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChoosing a generic drug instead of a brand name drug8 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSetting up a payment plan12 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmCopay assistance, coupons, or rebates for drugs6 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmReferring to hospital billing office5 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmStopping or pausing some treatments3 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting a community agency or charity2 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting a free drug program0 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting talking to human resources0 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmChoosing a lower cost procedure or scan0 cost strategies discussed
I Can PICDifference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC ArmSuggesting government assistance0 cost strategies discussed
Secondary

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

Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

Population: Only participants enrolled in the I Can PIC Arm were evaluable for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
I Can PICConfidence Communicating About Health Care Costs With Physician (I Can PIC Arm)Post-intervention survey13.81 score on a scaleStandard Deviation 2.75
I Can PICConfidence Communicating About Health Care Costs With Physician (I Can PIC Arm)3-6 month follow-up survey14.24 score on a scaleStandard Deviation 2.47
p-value: 0.71t-test, 2 sided
Secondary

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

Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

Population: Only participants enrolled in the I Can PIC Arm were evaluable for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
I Can PICHealth Insurance Knowledge Sustained Over Time (I Can PIC Arm)Post-intervention survey77.02 score on a scaleStandard Deviation 19.03
I Can PICHealth Insurance Knowledge Sustained Over Time (I Can PIC Arm)3-6 month follow-up survey75.6 score on a scaleStandard Deviation 20.01
Secondary

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

Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

Population: Only participants enrolled in the I Can PIC Arm were evaluable for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
I Can PICHealth Insurance Literacy Sustained Over Time (I Can PIC Arm)Post-intervention survey34.71 score on a scaleStandard Deviation 7.65
I Can PICHealth Insurance Literacy Sustained Over Time (I Can PIC Arm)3-6 month follow-up survey35.74 score on a scaleStandard Deviation 8.39
Secondary

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

Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

Population: Only participants enrolled in the I Can PIC Arm were evaluable for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
I Can PICSustained Financial Toxicity (I Can PIC Arm)Post-intervention survey16.06 score on a scaleStandard Deviation 9.83
I Can PICSustained Financial Toxicity (I Can PIC Arm)3-6 month follow-up survey14.17 score on a scaleStandard Deviation 10.72
p-value: 0.12t-test, 2 sided
Other Pre-specified

Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)

* Delayed or forgone care due to costs will be collected on the historical control survey and the I Can PIC post-intervention survey * Score from 0 (best) to 8 (worst). Higher scores indicate more frequent delayed and forgone care due to costs

Time frame: Completion of survey (estimated to be approximately 1-14 days after enrollment)

Population: 3 participants in the Historical Control Survey arm did not complete the survey.

ArmMeasureValue (MEAN)Dispersion
Historical Control SurveyDelayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)2.67 score on a scaleStandard Deviation 1.61
I Can PICDelayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)2.33 score on a scaleStandard Deviation 1.58
p-value: 0.66Kruskal-Wallis
Other Pre-specified

Delayed or Forgone Care Due to Costs (I Can PIC Arm)

* Delayed or forgone care due to costs will be collected on the post-intervention survey and the 3-6 month follow-up survey * Score from 0 (best) to 8 (worst). Higher scores indicate more frequent delayed and forgone care due to costs

Time frame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

Population: Only participants enrolled in the I Can PIC Arm were evaluable for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
I Can PICDelayed or Forgone Care Due to Costs (I Can PIC Arm)Post-intervention survey2.33 score on a scaleStandard Deviation 1.58
I Can PICDelayed or Forgone Care Due to Costs (I Can PIC Arm)3-6 month follow-up survey2.38 score on a scaleStandard Deviation 1.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026