Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

760

participants targeted

Target at P75+ for not_applicable

Timeline

19mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach

2 countries

181 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress58%

Feb 2024Dec 2027

First Submitted

Initial submission to the registry

February 14, 2024

Completed

15 days until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

February 14, 2024

Last Update Submit

May 1, 2026

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

Cost-related cancer care non-adherence
Cost-related cancer care non-adherence is defined as a positive response to any of the following due to costs: Delayed, forewent, stopped, or changed prescribed cancer medication; or delayed, forewent, or refused recommended cancer tests, or cancer office visits. Will be calculated as a report of non-adherence at any point up through the 12mo follow-up survey.
12 months

Secondary Outcomes (4)

Rate of Material Financial Hardship
at 12 months
Patient-reported financial worry
At baseline and at 3, 6 and 12 months
Patient-reported Quality of life - mental and physical health
At baseline and at 3, 6 and 12 months
Patient-reported satisfaction with care at 12 months
At baseline and at 3, 6 and 12 months

Other Outcomes (10)

Out of pocket cost (OOPC) accuracy
At 3, 6 and 12 months
Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population.
Up to 12 months
Patient reported satisfaction with intervention
39 months after enrollment of first study participant
+7 more other outcomes

Study Arms (3)

ARM A (Enhanced usual care)

ACTIVE COMPARATOR

Patients receive PAF brochure describing financial navigation services.

Other: Best PracticeOther: Survey Administration

ARM B (CostCOM)

EXPERIMENTAL

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.

Other: Best PracticeOther: Financial NavigationOther: Survey Administration

Non-patient participants: (interview)

EXPERIMENTAL

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.

Other: InterviewOther: Survey Administration

Interventions

Survey AdministrationOTHER

Ancillary studies

ARM A (Enhanced usual care)ARM B (CostCOM)Non-patient participants: (interview)

Best PracticeOTHER

Receive PAF brochure describing financial navigation services

Also known as: standard of care, standard therapy

ARM A (Enhanced usual care)ARM B (CostCOM)

Financial NavigationOTHER

Receive CostCOM financial counseling

Also known as: Financial Navigation Program

ARM B (CostCOM)

InterviewOTHER

Participate in a 1 on 1 in-depth interview

Non-patient participants: (interview)

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
+15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (181)

Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

RECRUITING

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

RECRUITING

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

RECRUITING

BASS Medical Group - Lennon

Walnut Creek, California, 94598, United States

RECRUITING

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

RECRUITING

Boulder Community Foothills Hospital

Boulder, Colorado, 80303, United States

RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

RECRUITING

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, 80112, United States

RECRUITING

The Women's Imaging Center

Denver, Colorado, 80209, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

SUSPENDED

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

RECRUITING

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, 80218, United States

RECRUITING

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, 80220, United States

RECRUITING

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, 80113, United States

SUSPENDED

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, 80113, United States

RECRUITING

The Melanoma and Skin Cancer Institute

Englewood, Colorado, 80113, United States

RECRUITING

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, 80228, United States

RECRUITING

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, 80120, United States

RECRUITING

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124, United States

RECRUITING

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, 80501, United States

RECRUITING

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, 80260, United States

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza