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Behavioural Intervention

ARM B (CostCOM) for Cancer

N/A
Recruiting
Led By Gelareh Sadigh
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6 and 12 months
Awards & highlights

Study Summary

This trial looks at how a program called Cost Communication and Financial Navigation (CostCOM) can help cancer patients with their medical costs and financial stress. Cancer patients often struggle with high medical costs and financial difficulties

Who is the study for?
The COSTCOM trial is for English or Spanish-speaking adults recently diagnosed with any solid cancer who have started or are about to start systemic therapy. It's also for healthcare workers at NCORP sites involved in financial aspects of patient care. Those not fluent in English/Spanish, without a new cancer diagnosis, or not undergoing treatment are excluded.Check my eligibility
What is being tested?
This study tests the Cost Communication and Financial Navigation (CostCOM) program designed to help cancer patients manage financial challenges related to their care. It aims to see if providing financial counseling and resources can improve adherence to treatments and reduce the stress of medical expenses.See study design
What are the potential side effects?
Since this trial involves surveys, interviews, and best practice interventions rather than medications, traditional side effects like those seen with drugs aren't expected. However, participants may experience emotional distress discussing finances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cost-related cancer care non-adherence
Secondary outcome measures
Patient-reported Quality of life - mental and physical health
Patient-reported financial worry
Patient-reported satisfaction with care at 12 months
+1 more
Other outcome measures
Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care
Out of pocket cost (OOPC) accuracy
Patient reported satisfaction with intervention
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Non-patient participants: (interview)Experimental Treatment2 Interventions
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 II: ARM B (CostCOM)Experimental Treatment3 Interventions
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 III: ARM A (Enhanced usual care)Active Control2 Interventions
Patients receive PAF brochure describing financial navigation services.

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,162 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,925,681 Total Patients Enrolled
Gelareh SadighPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
410 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively sought for this ongoing research study?

"The clinical trial is actively enrolling participants as per the information available on clinicaltrials.gov. The study was initially listed on February 29, 2024, and most recently revised on March 12, 2024."

Answered by AI

What is the current number of individuals being recruited to participate in this clinical trial?

"Affirmative. Information on clinicaltrials.gov affirms that this investigation is actively seeking subjects. The trial was originally listed on February 29, 2024, and the most recent update occurred on March 12, 2024. In total, the study aims to enroll 760 patients distributed among 48 locations."

Answered by AI

Are multiple medical facilities conducting this study within the United States?

"Currently, Mercy Hospital Joplin in Joplin, Ohio; Freeman Health System in Chillicothe, Arkansas; and Adena Regional Medical Center in Fort Smith, Illinois are among the sites accepting participants. There are an additional 48 locations involved in patient recruitment for this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Southern Ohio Medical Center
Clinton Memorial Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~507 spots leftby Feb 2029