Breast CancerNCT03615573
Survey Study: Financial Impact of Breast Cancer Treatment
An observational study of Breast Cancer, run by The Guthrie Clinic at 1 site in United States.
Trial summary
A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Quality of Life Surveys
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 10 Feb 2024
- 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
- Adult, Older adult
Study population: Patients seen at rural cancer center with diagnosis of breast cancer or a recurrence of breast cancer within the past 2 years
Who may be able to join
- 18 years or older
- Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years
- Willing to sign consent
- Able to read and complete surveys in English
Who cannot join
- Cancer diagnosis other than breast cancer
- More than 2 years since diagnosis with breast cancer or recurrence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center
A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.
- Conditions
- Breast Cancer
- Being tested
- Quality of Life Surveys
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life SurveysOther
Patients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of self-reported financial burden
Will evaluate the change in Comprehensive Score for Financial Toxicity (COST-FACIT) measurements from baseline to 1 year follow up. This survey consists of 14 questions related to finances.Responses include 5 options with lower scores representing worse outcomes. Scores at 1 year will be compared to baseline scores.
Measured: Baseline through 1 year
Secondary outcomes (2)
Change in level of self-reported health insurance literacy
Will evaluate the change in Health Insurance Literacy Measurements (HILM) from baseline to 1 year follow up
Measured: Baseline through 1 year
Self-reported access and utilization of institutional support services
Will evaluate reported access and utilization of institutional support services and its association to financial burden in the first 12 months after enrollment.
Measured: Baseline through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start4 Sep 2018
- Primary completion15 Jun 2022
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Perry-Keaty, RN FNP AOCNP, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615573
- Sponsor's protocol ID
- 1808-42
- Status last verified
- Nov 2024
- First submitted
- 31 Jul 2018
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center
- ClinicalTrials.gov ID
- NCT03615573
- Acronym / sponsor ID
- 1808-42
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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.
A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients seen at rural cancer center with diagnosis of breast cancer or a recurrence of breast cancer within the past 2 years
Key inclusion criteria (4 listed)
- 18 years or older
- Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years
- Willing to sign consent
- Able to read and complete surveys in English
Key exclusion criteria (2 listed)
- Cancer diagnosis other than breast cancer
- More than 2 years since diagnosis with breast cancer or recurrence
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 |
|---|---|---|
| Quality of Life SurveysPatients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment. | Other | – |
Primary outcome
Change in level of self-reported financial burden
Time frame: Baseline through 1 year
Will evaluate the change in Comprehensive Score for Financial Toxicity (COST-FACIT) measurements from baseline to 1 year follow up. This survey consists of 14 questions related to finances.Responses include 5 options with lower scores representing worse outcomes. Scores at 1 year will be compared to baseline scores.
2 secondary outcomes
Change in level of self-reported health insurance literacy
Time frame: Baseline through 1 year
Self-reported access and utilization of institutional support services
Time frame: Baseline through 1 year
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 7 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Cynthia Perry-Keaty, RN FNP AOCNP principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by The Guthrie Clinic at 1 site in United States.
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 4 inclusion and 2 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 7 Nov 2024. 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 United States. 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?
Change in level of self-reported financial burden (time frame: Baseline through 1 year). 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 7 Nov 2024.