Clinical trial Recruiting at 363 sites Interventional

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.

More Malignant Solid Neoplasm trials

Quick facts

Study typeInterventional
SexAll
Enrollment760 (estimated)
SponsorEastern Cooperative Oncology Group
Research network
Drugs / interventionsradiation
Locations391 sites (Anchorage, Alaska and 390 other locations)
StatusRecruiting
StartedApril 10, 2024
Main results expectedNovember 30, 2027
Study endsDecember 30, 2027
Registry record updatedOctober 29, 2026
Trial IDNCT06295367 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.