Helping cancer patients manage costs and financial stress
Official title: Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients
Run by Eastern Cooperative Oncology Group · NCT06295367 · Data updated 2026-11-12
This study is testing a new program to help cancer patients manage their costs and financial stress to see if it improves their ability to stick to treatment and their overall quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 760 (estimated) |
| Sponsor | Eastern Cooperative Oncology Group Research network |
| Drugs / interventions | radiation |
| Locations | 391 sites (Anchorage, Alaska and 390 other locations) |
| Status | Recruiting |
| Started | April 10, 2024 |
| Main results expected | November 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06295367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult cancer patients aged 18 and older who are experiencing financial hardship related to their cancer treatment.
✕Probably not a fit
Patients who are not currently undergoing treatment for malignant solid neoplasms or those who do not experience financial stress related to their care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the Cost Communication and Financial Navigation (CostCOM) intervention aimed at reducing financial burdens and improving adherence to cancer care among patients with malignant solid neoplasms. The study compares patient-reported outcomes related to cost-related non-adherence, financial hardship, and quality of life between those receiving enhanced usual care and those receiving the CostCOM intervention. Participants will be assessed at 12 months after completing a baseline survey to determine the effectiveness of the intervention in alleviating financial stress and improving overall patient satisfaction with care.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce financial barriers to cancer care, leading to better adherence to treatment and improved quality of life for patients.
How similar studies have gone: Other studies have shown that financial navigation programs can improve patient outcomes, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * NON-PATIENTS PARTICIPANTS: Participant must speak English * NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months * NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to participate in this study * NON-PATIENTS PARTICIPANTS: 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 the 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 fluent in written and spoken English OR patient must be fluent in written and spoken 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 * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of Step 0 * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not have indolent cancer undergoing observation alone (i.e., active surveillance) * 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 * 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. * 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 in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0) * PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy) either before or within 30 days of the date of OPEN registration and consent (step 0)
Where it's running
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States Recruiting -
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States Recruiting -
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States Recruiting -
Alaska Women's Cancer Care
Anchorage, Alaska, United States Recruiting -
Katmai Oncology Group
Anchorage, Alaska, United States Recruiting -
Providence Alaska Medical Center
Anchorage, Alaska, United States Recruiting
Show 44 more locations
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Fairbanks Memorial Hospital
Fairbanks, Alaska, United States Recruiting -
Kingman Regional Medical Center
Kingman, Arizona, United States Recruiting -
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States Recruiting -
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States Recruiting -
CARTI Cancer Center
Little Rock, Arkansas, United States Recruiting -
PCR Oncology
Arroyo Grande, California, United States Recruiting -
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States Recruiting -
Contra Costa Regional Medical Center
Martinez, California, United States Recruiting -
Providence Queen of The Valley
Napa, California, United States Recruiting -
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States Recruiting -
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States Recruiting -
BASS Medical Group - Lennon
Walnut Creek, California, United States Recruiting -
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States Recruiting -
Boulder Community Foothills Hospital
Boulder, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States Recruiting -
The Women's Imaging Center
Denver, Colorado, United States Recruiting -
Colorado Blood Cancer Institute
Denver, Colorado, United States Recruiting -
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States Recruiting -
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States Recruiting -
Liberty County Cancer Care
Hinesville, Georgia, United States Recruiting -
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States Recruiting -
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States Recruiting -
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States Recruiting -
Queen's Medical Center
Honolulu, Hawaii, United States Recruiting -
Straub Clinic and Hospital
Honolulu, Hawaii, United States Recruiting -
University of Hawaii Cancer Center
Honolulu, Hawaii, United States Recruiting -
Hawaii Diagnostic Radiology Services LLC
Honolulu, Hawaii, United States Recruiting -
Kuakini Medical Center
Honolulu, Hawaii, United States Recruiting -
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States Recruiting -
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States Recruiting -
Tripler Army Medical Center
Honolulu, Hawaii, United States Recruiting -
Straub Medical Center - Kahului Clinic
Kahului, Hawaii, United States Recruiting -
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States Recruiting -
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States Recruiting -
Pali Momi Medical Center
‘Aiea, Hawaii, United States Recruiting
+341 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Gelareh Sadigh — ECOG-ACRIN Cancer Research Group
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.