Financial Distress in Patients With Advanced Cancer (DIFIC)

This study is currently recruiting participants.
Verified June 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01868100
First received: May 30, 2013
Last updated: February 17, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention
Cancer
Quality of Life
Other: self-completion questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Preliminary Study of Financial Distress and Quality of Life in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Financial distress and quality of life [ Time Frame: Cross sectional (one day) ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 144
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: self-completion questionnaire Other: self-completion questionnaire

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868100

Contacts
Contact: Marilene FILBET, Professor 00 33 4 78 86 41 47 ext 0033 marilene.filbet@chu-lyon.fr
Contact: Wadih Rhondali, MD 00 33 4 78 86 44 25 ext 0033 wadihrhondali@gmail.com

Locations
France
Unité de soins palliatifs Groupement Hospitalier Sud Recruiting
Pierre-Bénite, Pierre Bénite, France, 69495
Principal Investigator: Marilene FILBET, Professor         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01868100     History of Changes
Other Study ID Numbers: 2012.762
Study First Received: May 30, 2013
Last Updated: February 17, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
Cancer
quality of life
palliative care
supportive care
Financial distress

ClinicalTrials.gov processed this record on April 16, 2014