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Financial Distress in Patients With Advanced Cancer (DIFIC)

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ClinicalTrials.gov Identifier: NCT01868100
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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 or disease Intervention/treatment Phase
Cancer Quality of Life Other: self-completion questionnaire Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Preliminary Study of Financial Distress and Quality of Life in Patients With Advanced Cancer
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
No Intervention: self-completion questionnaire Other: self-completion questionnaire



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868100


Locations
France
Unité de soins palliatifs Groupement Hospitalier Sud
Pierre-Bénite, Pierre Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01868100     History of Changes
Other Study ID Numbers: 2012.762
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: June 2013

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