Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment
Purpose
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
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational (questionnaire) | Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
Study Contact
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.