Clinical Trials Logo

Clinical Trial Summary

This clinical trial studies the use of the financial impact assessment tool in patients with colorectal cancer that has spread from the primary site to other places in the body. Gathering information about patients with colorectal cancer over time may help doctors better understand the financial impact of cancer and help patients avoid financial problems during treatment.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To estimate the incidence of treatment-related major financial hardship over 12 months, among patients with newly diagnosed metastatic colorectal cancer (mCRC) treated at Southwest Oncology Group (SWOG)-affiliated Cancer Care Delivery Research (CCDR) components of the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites.

SECONDARY OBJECTIVES:

I. To describe the association of major financial hardships with mCRC treatment by demographic factors, including age, race, marital status, employment status, and income.

II. To explore whether occurrence of major financial hardship is associated with poorer health-related quality of life over time.

III. To profile the magnitude and timing of treatment-related changes in patients' income, assets, debt, and employment, and to quantify major out-of-pocket expenses during the 12 months following registration.

IV. To explore the extent to which health insurance factors (e.g. high copayments, deductibles, premiums, loss/change of insurance plan) are associated with major financial hardship and treatment non-adherence.

V. To determine feasibility of recruiting primary caregivers and measuring caregiver burden and caregivers' perceptions about cancer treatment costs.

VI. To determine the feasibility of conducting a prospective-multi-site longitudinal cohort study assessing financial outcomes in patients with mCRC undergoing treatment within the NCORP network.

TERTIARY OBJECTIVES:

I. To obtain objective measures of expenses, debt and credit through linkage with individual patient credit reports (TransUnion) at enrollment (baseline) and end of follow up (12 months).

OUTLINE:

Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT02755571
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Not yet recruiting
Phase N/A
Start date July 2016

See also
  Status Clinical Trial Phase
Completed NCT01987726 - Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
Terminated NCT01198535 - Phase I Study of Cetuximab With RO4929097 in Metastatic Colorectal Cancer Phase 1
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01217450 - Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors Phase 1
Completed NCT01637194 - Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer Phase 1
Completed NCT00005036 - Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Phase 3
Completed NCT02393755 - Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT01131234 - Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00084643 - GTI-2040, Oxaliplatin, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors Phase 1
Terminated NCT00002796 - Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer Phase 1/Phase 2
Completed NCT01806675 - 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Phase 1/Phase 2
Completed NCT01643499 - Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies Phase 1
Withdrawn NCT02235324 - Ziv-Aflibercept Followed by Ziv-Aflibercept, Fluorouracil, and Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Phase 2
Terminated NCT01729923 - A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT01802320 - Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery Phase 2
Terminated NCT01320683 - Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02728804 - S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Completed NCT02041481 - MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer Phase 1
Terminated NCT01365910 - Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer Phase 2
Terminated NCT00499369 - Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy Phase 3