CancerDIFICNCT01868100
Financial Distress in Patients With Advanced Cancer
A study testing self-completion questionnaire in people with Cancer and Quality of Life, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Quality of Life
- What is being tested?
- self-completion questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinical evidence of cognitive impairment, as determined by the palliative care physician.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de soins palliatifs Groupement Hospitalier Sud
Pierre-Bénite, Pierre Bénite, 69495
About this study
Official title: 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.
- Conditions
- Cancer, Quality of Life
- Being tested
- self-completion questionnaire
- Keywords
- Cancer, quality of life, palliative care, supportive care, Financial distress
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-completion questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| self-completion questionnaire | No intervention | Not described Receives: Other: self-completion questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Cross sectional (one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868100
- Sponsor's protocol ID
- 2012.762
- Acronym
- DIFIC
- Status last verified
- Jun 2013
- First submitted
- 30 May 2013
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28545063
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Financial Distress and Quality of Life in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01868100
- Acronym / sponsor ID
- DIFIC / 2012.762
- Conditions
- Cancer, Quality of Life
- Keywords
- Cancer, quality of life, palliative care, supportive care, Financial distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self-completion questionnaire | No intervention | Other: self-completion questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Clinical evidence of cognitive impairment, as determined by the palliative care physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-completion questionnaire | Other | self-completion questionnaire |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 28545063Barbaret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-completion questionnaire in people with Cancer and Quality of Life, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial distress and quality of life (time frame: Cross sectional (one day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.