Financial Burden Assessment in Patients with Stage I-III Colon or Rectal Cancer Undergoing Treatment
Colon/Rectal Cancer
Unknown Primary
18 Years and older, Male and Female
EAQ162CD (primary)
NCI-2018-00151
EAQ162CD
ECOG-ACRIN-EAQ162CD
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.
Objectives
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.
Eligibility
- 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 or rectosigmoid junction (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have either not yet received radiation or chemotherapy or are starting radiation or chemotherapy on the same day as registration
- 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 are not eligible if they are to receive treatment at an outside facility throughout the duration of the trial
- 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 because it is possible that their employment and burden due to cancer care may be impacted by their previous malignancy and therefore add heterogeneity to the study
- Patients with two primary cancers that consist of colon, rectal or colorectal 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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