CancerNCT01169545
Cancer, Vulnerability, and Financial Quality of Life: A Mixed Methods Study
An observational study of Cancer, run by Georgetown University.
Trial summary
The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2012
- Phase
- Observational
- 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
Study population: Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent
Who may be able to join
- Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent
Who cannot join
- Pediatric patients; non-English-speaking patients
About this study
The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life.
Read the detailed description
The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life. For people who are experiencing financial hardship, a cancer diagnosis can be devastating. For others, cancer may cause or even worsen financial stress, for example, with their work, their ability to maintain benefits such as health insurance, their ability to pay bills, and their ability to get the cancer treatment they need. The impact of cancer on financial quality of life is an important area of study within cancer care. Considering the financial burden of cancer also lends greater appreciation for the problems that people face if they cannot handle cancer's costs, or if needed resources are either not present or are too stretched to help with the care they need. For this study, up to 180 cancer patients will be interviewed with a written questionnaire. Of this group, 15 people will also be asked if they would like to participate in a follow-up personal interview with the researcher. The major hypothesis of this study is: The greater the vulnerabilities in predisposing factors and enabling factors, the greater the need factors with respect to cancer diagnosis and treatment, and the lower the perceived ability to adhere to treatment, the poorer will be the financial quality of life.
- Conditions
- Cancer
- Keywords
- any type of cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients over the age of 18 | Cancer patients over the age of 18 who are receiving active treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Potential Vulnerabilities
To examine how vulnerabilities in psychological and social situations affect financial quality of life. The dependent variable in this study is financial quality of life, defined as the ability to manage all current and future (including unexpected) financial obligations related to cancer care, within the context of sound health-care decision-making. Under the theoretical framework used, the first three independent variables selected under the predisposing domain are housing instability, personal control within the larger context of health locus of control, and demographics. Under the enabling domain, the next variables measured are income and financial stress, presence of health insurance and health insurance adequacy, perceived barriers to care, and social support. For the need domain, a patient's experience with cancer in terms of treatment and acuity are measured. Variables are measured using standardized instruments or in the absence of one, a scale composed by the researcher.
Measured: May 2010 to October 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Callahan, PhD, LCSW-C, Georgetown University
- Investigators
- Christine C. Callahan, MSW, Principal investigator, The Catholic University of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169545
- Sponsor's protocol ID
- 2010-090
- Status last verified
- May 2015
- First submitted
- 22 Jul 2010
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer, Vulnerability, and Financial Quality of Life: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT01169545
- Acronym / sponsor ID
- 2010-090
- Conditions
- Cancer
- Keywords
- any type of cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jul 2010 (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.
The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life.
Detailed description
The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life. For people who are experiencing financial hardship, a cancer diagnosis can be devastating. For others, cancer may cause or even worsen financial stress, for example, with their work, their ability to maintain benefits such as health insurance, their ability to pay bills, and their ability to get the cancer treatment they need. The impact of cancer on financial quality of life is an important area of study within cancer care. Considering the financial burden of cancer also lends greater appreciation for the problems that people face if they cannot handle cancer's costs, or if needed resources are either not present or are too stretched to help with the care they need. For this study, up to 180 cancer patients will be interviewed with a written questionnaire. Of this group, 15 people will also be asked if they would like to participate in a follow-up personal interview with the researcher. The major hypothesis of this study is: The greater the vulnerabilities in predisposing factors and enabling factors, the greater the need factors with respect to cancer diagnosis and treatment, and the lower the perceived ability to adhere to treatment, the poorer will be the financial quality of life.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients over the age of 18 | – | –Cancer patients over the age of 18 who are receiving active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent
Key inclusion criteria (1 listed)
- Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent
Key exclusion criteria (1 listed)
- Pediatric patients; non-English-speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of Potential Vulnerabilities
Time frame: May 2010 to October 2012
To examine how vulnerabilities in psychological and social situations affect financial quality of life. The dependent variable in this study is financial quality of life, defined as the ability to manage all current and future (including unexpected) financial obligations related to cancer care, within the context of sound health-care decision-making. Under the theoretical framework used, the first three independent variables selected under the predisposing domain are housing instability, personal control within the larger context of health locus of control, and demographics. Under the enabling domain, the next variables measured are income and financial stress, presence of health insurance and health insurance adequacy, perceived barriers to care, and social support. For the need domain, a patient's experience with cancer in terms of treatment and acuity are measured. Variables are measured using standardized instruments or in the absence of one, a scale composed by the researcher.
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 18 May 2015.
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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.
Christine C. Callahan, MSW principal investigator
The Catholic University of America
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Georgetown University.
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 1 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Identification of Potential Vulnerabilities (time frame: May 2010 to October 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2015.