Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Financial Stress

Stress, Psychological

Behavioral Symptoms

-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.

-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.

I Can PIC

-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.

Historical control survey

Post-intervention 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.

Follow-Up survey (I Can PIC participants)

Mary Politi, Ph.D.

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.

Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

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

* 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

* 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

* 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

* 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

* 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

-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention 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

* 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

* 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

* 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

* Sustained Health insurance literacy will be collected on the post-intervention survey and the 3-6 month follow-up survey
* Score from 12 (worst) to 48 (best). Higher scores indicate greater health insurance literacy

* Confidence communicating about health care costs will be collected on the post-intervention survey and the 3-6 month follow-up survey
* Score from 4 (worst) to 16 (best). Higher scores indicate greater confidence communicating about care costs

* Sustained Financial toxicity 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

National Cancer Institute (NCI)

Washington University School of Medicine

Historical Control Survey

Total

One participant in the I Can PIC arm did not provide their age.

Age, Continuous

Female

Male

Unknown

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

3 participants who withdrew in the Historical Control Survey arm still provided their demographic data before withdrawing from the study and the demographic data is included. 1 participant in the I Can PIC arm did not provide their age which is why the number of participants for age, continuous is 67 and the total for age is 135.

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

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

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

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

Insurance eligibility or coverage

Time off work during treatment or recovery

Cost of drugs to treat cancer

Costs of getting to and from visits

Costs of specific tests, visits, or equipment

Cost of over-the-counter drugs

Comparing costs of options to help choose care

Cost of day-to-day living

Other

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

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

Changing logistics of care

Change the dose (amount) of treatment

Choosing a generic drug instead of a brand name drug

Setting up a payment plan

Copay assistance, coupons, or rebates for drugs

Referring to hospital billing office

Stopping or pausing some treatments

Suggesting a community agency or charity

Suggesting a free drug program

Suggesting talking to human resources

Choosing a lower cost procedure or scan

Suggesting government assistance

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

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

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

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

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

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

Post-intervention survey

3-6 month follow-up survey

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

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

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

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

Sustained Financial Toxicity (I Can PIC Arm)

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

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

Overall Study

The I Can PIC website will be provided to participants randomized to the experimental/intervention group.

Participants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.

Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.

Mary C Politi, PhD

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.

Improving Cancer Patients' Insurance Choices

Supporting Cancer Survivors' Health Insurance Marketplace Decisions

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions).

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Participants will be asked what health insurance plan they would choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity	NCT04314284	Gynecologic Can... Colorectal Canc... Lung Cancer	I Can PIC Historical cont... Post-interventi... Follow-Up surve...	18 Years -	Washington University School of Medicine
Improving Cancer Patients' Insurance Choices	NCT03592433	Cancer Health Literacy Health Insuranc... Health Services... Informed Decisi...	I Can PIC	18 Years - 64 Years	Washington University School of Medicine
Improving Cancer Patients' Insurance Choices	NCT03592433	Cancer Health Literacy Health Insuranc... Health Services... Informed Decisi...	I Can PIC	18 Years - 64 Years	Washington University School of Medicine
Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity	NCT04314284	Gynecologic Can... Colorectal Canc... Lung Cancer	I Can PIC Historical cont... Post-interventi... Follow-Up surve...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for i can pic

Every month we try and update this database with for i can pic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for i can pic

Every month we try and update this database with for i can pic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for i can pic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.