Hematopoietic and Lymphoid Cell NeoplasmNCT04694911
Development of the Oncology Opportunity Cost Assessment Tool
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study develops and tests an instrument to measure opportunity costs called the Oncology Opportunity Cost Assessment Tool (OOCAT) in cancer patients. Patients experience significant costs, both direct financial as well as indirect costs, associated with seeking cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Focus Group, Interview and Research or Clinical Assessment Tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 31 Jul 2021
- 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
- Men only
- Adult, Older adult
Study population: Patients treated for cancer at Jefferson Center City, Jefferson Methodist Hospital, or Jefferson Abington
Who may be able to join
- Treated for cancer at one of the 3 participating sites (Jefferson Center City, Jefferson Methodist Hospital, Jefferson Abington)
- English speaking
- Able to attend and participate in a focus group
Who cannot join
- Treated at a Jefferson site other than the ones mentioned
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Development of the Oncology Opportunity Cost Assessment Tool (OOCAT)
This study develops and tests an instrument to measure opportunity costs called the Oncology Opportunity Cost Assessment Tool (OOCAT) in cancer patients. Patients experience significant costs, both direct financial as well as indirect costs, associated with seeking cancer treatment. While the direct financial impact of care on patients is receiving increased attention, other important consequences, such as opportunity cost, remain largely unmeasured. Opportunity cost is an economics term that refers to the loss of potential benefits from other options when one option is chosen - if resources are used for one purpose, they are no longer available for the next best option. The information and knowledge gained from this study may help researchers develop the OOCAT, which may allow them to understand the opportunity cost of treatment for each patient. The OOCAT may then be used to determine not just the best medications for patients, but also the best comprehensive treatment plan that will allow them to get the right treatment in the right place at the right time.
- Being tested
- Focus Group, Interview, Research or Clinical Assessment Tool
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Participate in focus group
InterviewOther
Complete cognitive interview
Research or Clinical Assessment ToolOther
Also called Clinical Assessment Tool, Clinical Assessment Tool, Clinical or Research Assessment Tool
Receive OOCAT
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (focus group, interview, OOCAT) | FOCUS GROUP: Patients participate in focus group session over 60-90 minutes.
COGNITIVE INTERVIEW: Patients complete cognitive interview on the clarity, interpretability, and ease of use of the OOCAT.
FEASIBILITY TESTING: Patients receive OOCAT at the point of care, online, or via telephone, per patients' preference. Receives: Behavioral: Focus Group; Other: Interview; Other: Research or Clinical Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level opportunity costs associated with oncology care
Patient-identified themes that contribute to opportunity cost will be generated via patient focus groups
Measured: 1 Day of Interview
Development of the Oncology Opportunity Cost Assessment Tool (OOCAT)
Will organize themes into domains and will generate items representing each of the themes for inclusion in an instrument designed to measure patient opportunity cost of seeking care. Will perform cognitive interviews with a random sampling of patients from the cancer center to test initial instrument items to ensure content validity and clarity of each item.
Measured: 1 Day of Interview
Implementation of OOCAT
Will test the instrument as developed with patients receiving oncology care across the Jefferson Health System to gather preliminary data informing the reliability of the scale to measure opportunity cost of seeking care.
Measured: 1 Day of OOCAT administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start21 Nov 2019
- Primary completion11 May 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694911
- Sponsor's protocol ID
- 19G.854
- Other IDs
- JT 14788
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Oncology Opportunity Cost Assessment Tool (OOCAT)
- ClinicalTrials.gov ID
- NCT04694911
- Acronym / sponsor ID
- 19G.854
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 5 Jan 2021 (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.
This study develops and tests an instrument to measure opportunity costs called the Oncology Opportunity Cost Assessment Tool (OOCAT) in cancer patients. Patients experience significant costs, both direct financial as well as indirect costs, associated with seeking cancer treatment. While the direct financial impact of care on patients is receiving increased attention, other important consequences, such as opportunity cost, remain largely unmeasured. Opportunity cost is an economics term that refers to the loss of potential benefits from other options when one option is chosen - if resources are used for one purpose, they are no longer available for the next best option. The information and knowledge gained from this study may help researchers develop the OOCAT, which may allow them to understand the opportunity cost of treatment for each patient. The OOCAT may then be used to determine not just the best medications for patients, but also the best comprehensive treatment plan that will allow them to get the right treatment in the right place at the right time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (focus group, interview, OOCAT) | – | Behavioral: Focus Group, Other: Interview, Other: Research or Clinical Assessment ToolFOCUS GROUP: Patients participate in focus group session over 60-90 minutes. COGNITIVE INTERVIEW: Patients complete cognitive interview on the clarity, interpretability, and ease of use of the OOCAT. FEASIBILITY TESTING: Patients receive OOCAT at the point of care, online, or via telephone, per patients' preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients treated for cancer at Jefferson Center City, Jefferson Methodist Hospital, or Jefferson Abington
Key inclusion criteria (3 listed)
- Treated for cancer at one of the 3 participating sites (Jefferson Center City, Jefferson Methodist Hospital, Jefferson Abington)
- English speaking
- Able to attend and participate in a focus group
Key exclusion criteria (2 listed)
- Treated at a Jefferson site other than the ones mentioned
- Non-English Speaking
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 |
|---|---|---|
| Focus GroupParticipate in focus group | Behavioural | Health Services Research (focus group, interview, OOCAT) |
| InterviewComplete cognitive interview | Other | Health Services Research (focus group, interview, OOCAT) |
| Research or Clinical Assessment ToolAlso: Clinical Assessment Tool, Clinical Assessment Tool, Clinical or Research Assessment ToolReceive OOCAT | Other | Health Services Research (focus group, interview, OOCAT) |
Primary outcome
Patient-level opportunity costs associated with oncology care
Time frame: 1 Day of Interview
Patient-identified themes that contribute to opportunity cost will be generated via patient focus groups
Development of the Oncology Opportunity Cost Assessment Tool (OOCAT)
Time frame: 1 Day of Interview
Will organize themes into domains and will generate items representing each of the themes for inclusion in an instrument designed to measure patient opportunity cost of seeking care. Will perform cognitive interviews with a random sampling of patients from the cancer center to test initial instrument items to ensure content validity and clarity of each item.
Implementation of OOCAT
Time frame: 1 Day of OOCAT administration
Will test the instrument as developed with patients receiving oncology care across the Jefferson Health System to gather preliminary data informing the reliability of the scale to measure opportunity cost of seeking care.
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 29 Apr 2025.
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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?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Thomas Jefferson University 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 3 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 29 Apr 2025. 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?
Patient-level opportunity costs associated with oncology care (time frame: 1 Day of Interview). The study lists 3 primary outcomes in all. 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 29 Apr 2025.