Clinical trial · Observational
Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment
Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent
NCT03516942CI-TRIAL-00121025active not recruitingResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaire)
- description
- Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Comprehensive Score for Financial Toxicity (COST)
- timeFrame
- Baseline and 12 months after cancer diagnosis
- description
- The Comprehensive Score for Financial Toxicity (COST) COST is an 11-item patient-reported outcome (PRO) of financial hardship that uses a 7-day time window and 5-point Likert response scale (ranging from 0, indicating not at all, to 4, very much). Higher COST scores (range, 0-44) represent better financial well-being. The primary objective is to evaluate the change in the level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months from study registration. (12 mo - baseline)
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a life expectancy of \>= 24 months * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 * Patients must have a newly diagnosed colon or rectal cancer (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have not yet received radiation or chemotherapy * Patients must have stage I, II, or III disease at the time of enrollment and will be treated with curative-intent; this can be defined either clinically or pathologically if they have already undergone surgery; for staging of both colon and rectal cancer, the definition of stage I-III is based on the seventh edition (2010) or an updated version of the tumor, node, metastasis (TNM) staging system * Patients are not eligible if they are already enrolled on a treatment clinical trial at the time of registration; they can remain on the study if they subsequently enroll on a treatment clinical trial during the study time period * Patients who choose to not receive radiation and/or chemotherapy after a curative-intent surgery are eligible to participate * Patients with a history of previous malignancy (except non-melanoma skin or cervical in-situ cancer) treated (with either surgery, chemotherapy, and/or radiation) within the last 3 years are not eligible * Patients must be able to complete questionnaires in English * Patients must sign and give written informed consent in accordance with institutional and federal guidelines
References
Publications (2)
- DERIVEDSadigh G, Duan F, An N, Gareen ID, Sicks J, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Taylor MA, Park E, Wagner LI, Kircher SM, Carlos RC. Financial Hardship Among Patients With Early-Stage Colorectal Cancer. JAMA Netw Open. 2024 Sep 3;7(9):e2431967. doi: 10.1001/jamanetworkopen.2024.31967. PMID 39287948
- DERIVEDKircher S, Duan F, An N, Gareen IF, Sicks JD, Sadigh G, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Park ER, Wagner LI, Carlos RC. Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer. JAMA Netw Open. 2024 Jan 2;7(1):e2350844. doi: 10.1001/jamanetworkopen.2023.50844. PMID 38194233