Trials / Active Not Recruiting
Active Not RecruitingNCT03516942
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 565 (actual)
- Sponsor
- ECOG-ACRIN Cancer Research Group · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. Evaluate the change in level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months after diagnosis of colon or rectal cancer treated with curative-intent. SECONDARY OBJECTVIES: I. Evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent. II. Evaluate the change in level of self-reported financial burden and employment limitations from baseline (within 60 days of diagnosis) to 3, 6, and 12 months after diagnosis of colon or rectal cancer treated with curative-intent. III. Evaluate long term outcomes at 24 months after diagnosis including financial burden, employment limitations and adherence to clinical follow-up guidelines. IV. Evaluate the change of quality-of-life outcome (QoL) from baseline to 12 months and its association with predictors. V. Evaluate the change in level of self-reported financial burden from baseline to 12 months using alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer \[EORTC\] questionnaire \[Q\]30). OUTLINE: Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.
Conditions
- Stage I Colon Cancer AJCC v8
- Stage I Rectal Cancer AJCC v8
- Stage II Colon Cancer AJCC v8
- Stage II Rectal Cancer AJCC v8
- Stage IIA Colon Cancer AJCC v8
- Stage IIA Rectal Cancer AJCC v8
- Stage IIB Colon Cancer AJCC v8
- Stage IIB Rectal Cancer AJCC v8
- Stage IIC Colon Cancer AJCC v8
- Stage IIC Rectal Cancer AJCC v8
- Stage III Colon Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
- Stage IIIA Colon Cancer AJCC v8
- Stage IIIA Rectal Cancer AJCC v8
- Stage IIIB Colon Cancer AJCC v8
- Stage IIIB Rectal Cancer AJCC v8
- Stage IIIC Colon Cancer AJCC v8
- Stage IIIC Rectal Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2023-12-31
- Completion
- 2028-09-01
- First posted
- 2018-05-07
- Last updated
- 2026-03-13
- Results posted
- 2025-02-17
Locations
716 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03516942. Inclusion in this directory is not an endorsement.