Cost Communication and Financial Navigation in Cancer Patients, COSTCOM Trial

Inclusion Criteria

• NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 0 (SCREENING): Participant must immediately be enrolled to Step 1 (Registration)
• NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION): Participant must speak English
• 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
• NON-PATIENTS PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION): Participant must be able to provide informed consent to participate in this study
• 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
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be ≥ 18 years of age
• 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
• 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
• 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
• 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
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone
• 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
• 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
• 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
• 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)
• 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
• 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
• 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
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form
• 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)
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy)
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Step 1 registration must be within 45 days of step 0 registration