Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04314284
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer; Colorectal Cancer; Lung Cancer	Behavioral: I Can PIC; Other: Historical control survey; Other: Post-intervention survey (I Can PIC participants); Other: Follow-Up survey (I Can PIC participants)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
• Actual Study Start Date: May 26, 2020
• Actual Primary Completion Date: Aug 27, 2021
• Actual Study Completion Date: Nov 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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.
Experimental: 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.	Behavioral: 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.; Other: 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: 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.

Outcome Measures

Primary Outcome Measures

1. Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm [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

2. Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm [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

3. Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm [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

4. Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm [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

5. Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm [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

6. Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm [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

7. Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm [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

8. Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm [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

9. Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs [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

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. 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 Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mary Politi, Ph.D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2021
• Informed Consent Form - Oct 27, 2020

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04314284
• Other Study ID Numbers: 202003033; 1P50CA244431-01
• First Posted: Mar 19, 2020
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Financial Stress

Study Results

Participant Flow

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Period Title: Overall Study
STARTED	69	81
COMPLETED	65	68
NOT COMPLETED	4	13

Baseline Characteristics

Arm/Group Title	Historical Control Survey	I Can PIC	Total
Arm/Group Description	-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.	-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 of all reporting groups
Overall Participants	68	68	136
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61.5	60	61
Sex/Gender, Customized (Count of Participants)
Female	40 58.8%	43 63.2%	83 61%
Male	25 36.8%	25 36.8%	50 36.8%
Unknown	3 4.4%	0 0%	3 2.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.5%	0 0%	1 0.7%
Not Hispanic or Latino	64 94.1%	68 100%	132 97.1%
Unknown or Not Reported	3 4.4%	0 0%	3 2.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.5%	0 0%	1 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 5.9%	3 4.4%	7 5.1%
White	58 85.3%	65 95.6%	123 90.4%
More than one race	2 2.9%	0 0%	2 1.5%
Unknown or Not Reported	3 4.4%	0 0%	3 2.2%
Region of Enrollment (participants) [Number]
United States	68 100%	68 100%	136 100%

Outcome Measures

1. Primary Outcome

Title	Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	65	68
Mean (Standard Deviation) [score on a scale]	72.45 (18.77)	77.02 (19.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	Kruskal-Wallis
	Comments

2. Primary Outcome

Title	Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	65	68
Mean (Standard Deviation) [score on a scale]	33.03 (8.56)	34.71 (7.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Kruskal-Wallis
	Comments

3. Primary Outcome

Title	Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	68	68
Count of Participants [Participants]	46 67.6%	39 57.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	Chi-squared
	Comments

4. Primary Outcome

Title	Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Description	-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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	68	68
Insurance eligibility or coverage	32	33
Time off work during treatment or recovery	16	15
Cost of drugs to treat cancer	9	11
Costs of getting to and from visits	8	1
Costs of specific tests, visits, or equipment	7	5
Cost of over-the-counter drugs	3	6
Comparing costs of options to help choose care	3	0
Cost of day-to-day living	2	2
Other	1	2

5. Primary Outcome

Title	Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm
Description	-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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	68	68
Count of Participants [Participants]	32 47.1%	33 48.5%

6. Primary Outcome

Title	Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Description	-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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	68	68
Changing logistics of care	21	18
Change the dose (amount) of treatment	7	8
Choosing a generic drug instead of a brand name drug	6	8
Setting up a payment plan	2	12
Copay assistance, coupons, or rebates for drugs	2	6
Referring to hospital billing office	8	5
Stopping or pausing some treatments	4	3
Suggesting a community agency or charity	2	2
Suggesting a free drug program	1	0
Suggesting talking to human resources	1	0
Choosing a lower cost procedure or scan	0	0
Suggesting government assistance	0	0
Other	4	1

7. Primary Outcome

Title	Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	64	68
Mean (Standard Deviation) [score on a scale]	13.59 (2.92)	13.81 (2.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	Kruskal-Wallis
	Comments

8. Primary Outcome

Title	Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	65	68
Mean (Standard Deviation) [score on a scale]	17.71 (11.20)	16.06 (9.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Kruskal-Wallis
	Comments

9. Primary Outcome

Title	Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs
Description	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)]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	68	68
Count of Participants [Participants]	11 16.2%	14 20.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	Chi-squared
	Comments

10. Secondary Outcome

Title	Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	0	68
Post-intervention survey	77.02 (19.03)
3-6 month follow-up survey	75.6 (20.01)

11. Secondary Outcome

Title	Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	0	68
Post-intervention survey	34.71 (7.65)
3-6 month follow-up survey	35.74 (8.39)

12. Secondary Outcome

Title	Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	0	68
Post-intervention survey	13.81 (2.75)
3-6 month follow-up survey	14.24 (2.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Other
	Comments	2-sided
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Sustained Financial Toxicity (I Can PIC Arm)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	0	68
Post-intervention survey	16.06 (9.83)
3-6 month follow-up survey	14.17 (10.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	I Can PIC
	Comments
	Type of Statistical Test	Other
	Comments	2-sided
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	t-test, 2 sided
	Comments

14. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	0	68
Post-intervention survey	2.33 (1.58)
3-6 month follow-up survey	2.38 (1.50)

15. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Historical Control Survey	I Can PIC
Arm/Group Description	-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.	-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.
Measure Participants	65	68
Mean (Standard Deviation) [score on a scale]	2.67 (1.61)	2.33 (1.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control Survey, I Can PIC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	From start of study through completion of study (estimated to be 3-6 months).
Arm/Group Title	Historical Control Survey		I Can PIC
Arm/Group Description	-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.		-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.
All Cause Mortality
	Historical Control Survey		I Can PIC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/68 (10.3%)		2/68 (2.9%)
Serious Adverse Events
	Historical Control Survey		I Can PIC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	Historical Control Survey		I Can PIC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.