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NCT06295367

Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To compare patient-reported cost-related cancer care non-adherence at 12 months after completion of baseline survey between the enhanced usual care (EUC) and CostCOM study arms.

SECONDARY OBJECTIVES:

I. To compare patient-reported material financial hardship at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

II. To compare patient-reported financial worry at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

III. To compare patient-reported quality of life at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

IV. To compare patient satisfaction with care at 12 months after completion of baseline survey 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 non-adherence, material hardship, financial worry, quality of life and satisfaction with care.

OUTLINE:

Non-patient participants: Participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment.

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 are followed up within 12 months of study intervention completion.

Conditions

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Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ARM A (Enhanced usual care)

Patients receive PAF brochure describing financial navigation services.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive PAF brochure describing financial navigation services

Survey Administration

Intervention Type OTHER

Ancillary studies

ARM B (CostCOM)

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive PAF brochure describing financial navigation services

Financial Navigation

Intervention Type OTHER

Receive CostCOM financial counseling

Survey Administration

Intervention Type OTHER

Ancillary studies

Non-patient participants: (interview)

Non-patient participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment.

Group Type EXPERIMENTAL

Interview

Intervention Type OTHER

Participate in a 1 on 1 in-depth interview

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive PAF brochure describing financial navigation services

Intervention Type OTHER

Financial Navigation

Receive CostCOM financial counseling

Intervention Type OTHER

Interview

Participate in a 1 on 1 in-depth interview

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Financial Navigation Program

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gelareh Sadigh

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status RECRUITING

CARTI Cancer Center

Little Rock, Arkansas, United States

Site Status RECRUITING

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status RECRUITING

BASS Medical Group - Lennon

Walnut Creek, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status RECRUITING

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status RECRUITING

The Women's Imaging Center

Denver, Colorado, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status SUSPENDED

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status RECRUITING

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Site Status RECRUITING

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status RECRUITING