Financial Distress in Patients With Advanced Cancer (DIFIC)

May 23, 2019 updated by: Hospices Civils de Lyon

Preliminary Study of Financial Distress and Quality of Life in Patients With Advanced Cancer

Advanced cancer has an adverse effect in virtually all dimensions of patients' lives (physical, psychosocial, spiritual, familial, role function). One of the less frequently explored effects of cancer is its impact on personal finances and the contribution of financial-related distress to overall suffering and quality of life. Financial issues have been recently found to be the second most frequent source of distress identified by cancer patients in a community cancer center context (22%).

In the context of continuous increased health care costs, it is likely that the frequency of health care related financial problems will keep rising. The relative contribution of these adverse financial events in advanced cancer patients to overall patient distress is not well assessed and this is particularly true in France. The main objective of this work is to determine the association between financial distress and quality of life of patients with advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A secondary objective is to characterize the frequency and intensity of financial distress reported by French cancer patients and their impact on their quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pierre Bénite
      • Pierre-Bénite, Pierre Bénite, France, 69495
        • Unité de soins palliatifs Groupement Hospitalier Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be at least 18 years old and have a diagnosis of advanced cancer which is defined as one of the following: recurrent disease, received >2 lines of chemotherapy, locally-advanced disease, metastatic disease, or refractory disease.
  • Patients must have a cancer diagnosis of: breast, colon, lung or prostate.
  • Patients must be able to understand, read, write, and speak French.

Exclusion Criteria:

  • Clinical evidence of cognitive impairment, as determined by the palliative care physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: self-completion questionnaire
Other: self-completion questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Financial distress and quality of life
Time Frame: Cross sectional (one day)
FACT-G; FACT-pal; FACT-sp for the quality of life; Self-assessment of financial distress in a 0 to 10 scale(0 no distress; 10 maximal distress)
Cross sectional (one day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012.762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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