Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment



Status:Recruiting
Conditions:Colorectal Cancer, Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:May 17, 2018
End Date:September 1, 2028

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Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent

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.

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.

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
We found this trial at
1
site
Philadelphia, Pennsylvania 19103
Principal Investigator: Sheetal Kircher, MD
Phone: 312-695-6180
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mi
from
Philadelphia, PA
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