Trial Outcomes & Findings for Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity (NCT NCT04314284)
NCT ID: NCT04314284
Last Updated: 2023-05-09
Results Overview
* 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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
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
-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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
81
|
|
Overall Study
COMPLETED
|
65
|
68
|
|
Overall Study
NOT COMPLETED
|
4
|
13
|
Reasons for withdrawal
| Measure |
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
-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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Consented but did not complete survey
|
0
|
6
|
Baseline Characteristics
One participant in the I Can PIC arm did not provide their age.
Baseline characteristics by cohort
| Measure |
Historical Control Survey
n=68 Participants
-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
n=68 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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
n=68 Participants • One participant in the I Can PIC arm did not provide their age.
|
60 years
n=67 Participants • One participant in the I Can PIC arm did not provide their age.
|
61 years
n=135 Participants • One participant in the I Can PIC arm did not provide their age.
|
|
Sex/Gender, Customized
Female
|
40 Participants
n=68 Participants
|
43 Participants
n=68 Participants
|
83 Participants
n=136 Participants
|
|
Sex/Gender, Customized
Male
|
25 Participants
n=68 Participants
|
25 Participants
n=68 Participants
|
50 Participants
n=136 Participants
|
|
Sex/Gender, Customized
Unknown
|
3 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
3 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
1 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=68 Participants
|
68 Participants
n=68 Participants
|
132 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=68 Participants
|
3 Participants
n=68 Participants
|
7 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=68 Participants
|
65 Participants
n=68 Participants
|
123 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
3 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=68 Participants
|
68 participants
n=68 Participants
|
136 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
Historical Control Survey
n=65 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm
|
72.45 score on a scale
Standard Deviation 18.77
|
77.02 score on a scale
Standard Deviation 19.03
|
PRIMARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
Historical Control Survey
n=65 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm
|
33.03 score on a scale
Standard Deviation 8.56
|
34.71 score on a scale
Standard Deviation 7.65
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Historical Control Survey
n=68 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm
|
46 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Historical Control Survey
n=68 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Insurance eligibility or coverage
|
32 cost-related topics discussed
|
33 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Time off work during treatment or recovery
|
16 cost-related topics discussed
|
15 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Cost of drugs to treat cancer
|
9 cost-related topics discussed
|
11 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Costs of getting to and from visits
|
8 cost-related topics discussed
|
1 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Costs of specific tests, visits, or equipment
|
7 cost-related topics discussed
|
5 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Cost of over-the-counter drugs
|
3 cost-related topics discussed
|
6 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Comparing costs of options to help choose care
|
3 cost-related topics discussed
|
0 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Cost of day-to-day living
|
2 cost-related topics discussed
|
2 cost-related topics discussed
|
|
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Other
|
1 cost-related topics discussed
|
2 cost-related topics discussed
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Historical Control Survey
n=68 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm
|
32 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Historical Control Survey
n=68 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Changing logistics of care
|
21 cost strategies discussed
|
18 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Change the dose (amount) of treatment
|
7 cost strategies discussed
|
8 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Choosing a generic drug instead of a brand name drug
|
6 cost strategies discussed
|
8 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Setting up a payment plan
|
2 cost strategies discussed
|
12 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Copay assistance, coupons, or rebates for drugs
|
2 cost strategies discussed
|
6 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Referring to hospital billing office
|
8 cost strategies discussed
|
5 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Stopping or pausing some treatments
|
4 cost strategies discussed
|
3 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Suggesting a community agency or charity
|
2 cost strategies discussed
|
2 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Suggesting a free drug program
|
1 cost strategies discussed
|
0 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Suggesting talking to human resources
|
1 cost strategies discussed
|
0 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Choosing a lower cost procedure or scan
|
0 cost strategies discussed
|
0 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Suggesting government assistance
|
0 cost strategies discussed
|
0 cost strategies discussed
|
|
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Other
|
4 cost strategies discussed
|
1 cost strategies discussed
|
PRIMARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
Historical Control Survey
n=64 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm
|
13.59 score on a scale
Standard Deviation 2.92
|
13.81 score on a scale
Standard Deviation 2.75
|
PRIMARY outcome
Timeframe: 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
* 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
Outcome measures
| Measure |
Historical Control Survey
n=65 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm
|
17.71 score on a scale
Standard Deviation 11.20
|
16.06 score on a scale
Standard Deviation 9.83
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Historical Control Survey
n=68 Participants
-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
n=68 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.
|
|---|---|---|
|
Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
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
n=68 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.
|
|---|---|---|
|
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
Post-intervention survey
|
—
|
77.02 score on a scale
Standard Deviation 19.03
|
|
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
3-6 month follow-up survey
|
—
|
75.6 score on a scale
Standard Deviation 20.01
|
SECONDARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
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
n=68 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.
|
|---|---|---|
|
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
Post-intervention survey
|
—
|
34.71 score on a scale
Standard Deviation 7.65
|
|
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
3-6 month follow-up survey
|
—
|
35.74 score on a scale
Standard Deviation 8.39
|
SECONDARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
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
n=68 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.
|
|---|---|---|
|
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
3-6 month follow-up survey
|
—
|
14.24 score on a scale
Standard Deviation 2.47
|
|
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
Post-intervention survey
|
—
|
13.81 score on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
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
n=68 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.
|
|---|---|---|
|
Sustained Financial Toxicity (I Can PIC Arm)
Post-intervention survey
|
—
|
16.06 score on a scale
Standard Deviation 9.83
|
|
Sustained Financial Toxicity (I Can PIC Arm)
3-6 month follow-up survey
|
—
|
14.17 score on a scale
Standard Deviation 10.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
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
n=68 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.
|
|---|---|---|
|
Delayed or Forgone Care Due to Costs (I Can PIC Arm)
Post-intervention survey
|
—
|
2.33 score on a scale
Standard Deviation 1.58
|
|
Delayed or Forgone Care Due to Costs (I Can PIC Arm)
3-6 month follow-up survey
|
—
|
2.38 score on a scale
Standard Deviation 1.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
* 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
Outcome measures
| Measure |
Historical Control Survey
n=65 Participants
-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
n=68 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.
|
|---|---|---|
|
Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)
|
2.67 score on a scale
Standard Deviation 1.61
|
2.33 score on a scale
Standard Deviation 1.58
|
Adverse Events
Historical Control Survey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
I Can PIC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary Politi, Ph.D.
Washington University School of Medicine
Phone: 314-747-1967
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place