NCT01868100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 28, 2019

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

May 30, 2013

Last Update Submit

May 23, 2019

Conditions

Keywords

Cancerquality of lifepalliative caresupportive careFinancial distress

Outcome Measures

Primary Outcomes (1)

  • Financial distress and quality of life

    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)

Study Arms (1)

self-completion questionnaire

NO INTERVENTION
Other: self-completion questionnaire

Interventions

self-completion questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de soins palliatifs Groupement Hospitalier Sud

Pierre-Bénite, Pierre Bénite, 69495, France

Location

Related Publications (1)

  • Barbaret C, Brosse C, Rhondali W, Ruer M, Monsarrat L, Michaud P, Schott AM, Delgado-Guay M, Bruera E, Sanchez S, Filbet M. Financial distress in patients with advanced cancer. PLoS One. 2017 May 18;12(5):e0176470. doi: 10.1371/journal.pone.0176470. eCollection 2017.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 4, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 28, 2019

Record last verified: 2013-06

Locations