Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
ARM A (Enhanced usual care)
Patients receive PAF brochure describing financial navigation services.
  • Other: Best Practice
    Receive PAF brochure describing financial navigation services
    Other names:
    • standard of care
    • standard therapy
  • Other: Survey Administration
    Ancillary studies
Experimental
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.
  • Other: Best Practice
    Receive PAF brochure describing financial navigation services
    Other names:
    • standard of care
    • standard therapy
  • Other: Financial Navigation
    Receive CostCOM financial counseling
    Other names:
    • Financial Navigation Program
  • Other: Survey Administration
    Ancillary studies
Experimental
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.
  • Other: Interview
    Participate in a 1 on 1 in-depth interview
  • Other: Survey Administration
    Ancillary studies

Recruiting Locations

University of Kansas Clinical Research Center
Fairway, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

The University of Kansas Cancer Center - Olathe
Olathe, Kansas 66061
Contact:
Site Public Contact
913-588-1569
OlatheCCResearch@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671

University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000

More Details

Status
Recruiting
Sponsor
ECOG-ACRIN Cancer Research Group

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.