Return to results

Cancer

EAQ222CD-Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

Description

We will conduct a patient-level randomized controlled trial of CostCOM vs. enhanced usual care (EUC) to assess effectiveness on cost-related cancer care nonadherence (primary), material hardship, financial worry, and QOL (secondary) at 12 months in 720 newly diagnosed patients with solid tumor (stratified by stage: nonmetastatic vs. metastatic) and plan to receive treatment in the next 30 days at any of the participating NCORP practices. Patients in both arms are surveyed at baseline, 3, 6, and 12 months after enrollment. A process evaluation will be conducted to assess providers’ and patients’ satisfaction with CostCOM, and perceived barriers and facilitators to CostCOM delivery or receipt.

Inclusion Notes

For a full description of this trial, please go to the listing on www.clinicaltrials.gov

For Medical Professionals

 

Inclusion:

  • Patient must be ≥ 18 years of age
  • Patient must be able to answer surveys and interact with the study team OR Patient must be able to answer surveys and interact with the study team in Spanish
  • 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 non-melanoma 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 must have had their first oncology visit at the time of Step 0.

NOTE: The oncology visit refers to the visit where the cancer systemic therapy is prescribed.

  • Patient must have initiated oral or 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.
  • Patients must not be receiving palliative or hospice care alone.
  • Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy).

NOTE: This only applies to the new index cancer diagnosis.

  • Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices.
  • 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 must not have an 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 must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient.
  • 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 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.

Start Date

Thursday, October 30, 2025

Principal / Contact Name

Dr. Henry

Phone

912-819-5704