Summary

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer.

Objectives

PRIMARY OBJECTIVE:
I. To compare patient-reported cost-related cancer care nonadherence at 12 months after randomization between the enhanced usual care (EUC) and CostCOM study arms.

SECONDARY OBJECTIVES:
I. To compare patient-reported material financial hardship at 12 months after randomization between the EUC and CostCOM study arms.
II. To compare patient-reported financial worry at 12 months after randomization between the EUC and CostCOM study arms.
III. To compare patient-reported quality of life at 12 months after randomization between the EUC and CostCOM study arms.
IV. To compare patient satisfaction with care at 12 months after randomization between the EUC and CostCOM study arms.

EXPLORATORY OBJECTIVES:
I. To describe CostCOM (Arm B) patients and their provider experience with various implementation outcomes.
II. To assess accuracy of out-of-pocket estimates communicated with the CostCOM (Arm B) patients at part of the intervention with their reported actual out-of-pocket cost.
III. To compare neighborhood characteristics of patient participants versus (vs.) practice patient population.
IV. To assess patients’ satisfaction with CostCOM in patients with Arm B.
V. To assess patients’ receipt of financial navigation via internal practice or external resources.
VI. To evaluate longitudinal changes in cost-related cancer care nonadherence, material hardship, financial worry, quality of life and satisfaction with care.

OUTLINE:
Non-patient participants: Participants complete surveys and participate in a 1 on 1 in depth semi-structured interview over 20-30 minutes beginning 15 months after the first patient randomization.

Patients are randomized to 1 of 2 arms.

ARM A: Patients receive Patient Advocate Foundation (PAF) brochure describing financial navigation services.

ARM B: Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months.

Patients in both arms are followed up at 3, 6, and 12 months after study randomization. Additionally, patients in Arm A may be followed up within 18 months after study randomization.

Eligibility

1. NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 0 (SCREENING): Participant must immediately be enrolled to Step 1 (Registration)
2. NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION): Participant must speak English
3. NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION): Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months
4. NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION): Participant must be able to provide informed consent to participate in this study
5. NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION): Participant must be one of the following: * A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform * A practice oncology provider (i.e., physician or mid-level), or * A practice financial counselor, social workers, financial navigators, or pharmacist who have provided care or been in contact (in the last 3 months) to a patient who was assigned to the CostCOM arm, and who completed at least 6 month study follow-up
6. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be = 18 years of age
7. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be able to answer surveys and interact with the study team in English OR patient must be able to answer surveys and interact with the study team in Spanish
8. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be within 120 days of a new diagnosis of any solid cancer of any stage at the time of step 0 * NOTE: Patients with a new diagnosis of stage 0 or in-situ cancer are eligible only if systemic therapy has been initiated or planned. * NOTE: Patients with a new recurrence of a primary cancer are not eligible as this is not considered a new diagnosis of cancer. * NOTE: Patients with a history of prior cancer diagnosis and/or treatment in the previous 24 months are not eligible. Exceptions are as follows: ** Patients with a history of prior nonmelanoma skin cancer are eligible even if they were diagnosed and/or treated in the last 24 months. ** Patients with a history of prior in-situ cancer are eligible even if they were diagnosed and/or treated in the last 24 months. ** Patients with a history of prior breast cancer only receiving adjuvant hormonal therapy in the last 24 months are eligible if they were diagnosed more than 24 months ago. * NOTE: Patients with a history of prior cancer diagnosis and/or treatment more than 24 months ago are eligible
9. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of step 0 * NOTE: The oncology visit refers to the visit where the cancer systemic therapy is prescribed
10. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy either any time before step 0 registration or have received a prescription order with stated intent to initiate within 30 days following step 0 registration
11. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone
12. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy), unless they are receiving systemic therapy * NOTE: This only applies to the new index cancer diagnosis
13. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices
14. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have the ability to understand and the willingness to sign a written informed consent document. * NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible
15. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status = 3, OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)
16. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient
17. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials. * NOTE: If S1912CD is activated in a participating practice, S1912CD should be offered first to patients with metastatic cancer meeting eligibility criteria for S1912CD. Only if a patient is not eligible or not interested in participating in S1912CD, the EAQ222CD can be offered. For early stage cancer, EAQ222CD can be offered first given S1912CD does not enroll patients with early stage cancer
18. PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in other clinical trials where OOPC communication or financial navigation (i.e., professional guidance to identify financial assistance programs to alleviate cost of care) is being offered as part of the trial * NOTE: If a trial is offering financial counseling alone without financial navigation patients are allowed to co-enroll * NOTE: Gift cards for survey completion, or parking passes are not considered financial navigation
19. PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0
20. PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form
21. PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have a completed baseline survey within 30 days of the date of OPEN screening registration (step 0)
22. PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy)
23. PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Step 1 registration must be within 45 days of step 0 registration

Treatment Sites in Georgia