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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-00315 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22-012283 | Other Identifier | Mayo Clinic in Rochester | |
| FD 05938 | Other Grant/Funding Number | Food and Drug Administration |
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This study examines qualitative techniques in defining meaningful within patients changes in symptoms in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). This study may help researcher better understand how to interpret reports from patients about their cancer symptoms and treatment side effects.
PRIMARY OBJECTIVES:
I. To develop method to establish meaningful change in patient-reported outcomes (PROs).
II. To provide responder definitions in 2 ways:
IIa: Detectable change: within patient score change patients perceive but does not exceed a subjective threshold for a modification to patient care (for worsening) or conclusion of achieving therapeutic benefit (for improvement); IIb. Meaningful change: within patient score change that patients perceive and that does require modification in management (for worsening) or supports conclusion of therapeutic benefit (improvement).
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
PATIENTS: Patients take part in an interview on study.
PATIENT ADVOCATES: Patient advocate participants take part in an interview on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Patient Group | Patients take part in interview on study. |
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| Observational Patient Advocate Group | Patient advocate participants take part in an interview on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Meaningful change in patient reported outcomes (PROs) | Change in PROs will be assessed using the critical incident technique (CIT) during semi-structured interviews as a means of educating, training, and evaluating patients on the concept of meaningful change. Interviews will be summarized to record how patients explain the concept of meaningful improvement and declines in their own words. | Baseline |
| Change in Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores | PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE). Scores will be evaluated for worsening from good days (baseline) and improvement from bad days (baseline). | Baseline |
| Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores | The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that measures four domains of Health-Related Quality of Life (HRQOL) in cancer patients: physical, social, emotional, and functional well-being. Questions are answered with a 0-4 scale where 0=Not at all and 4=Very much. Scores will be evaluated for worsening from good days (baseline) and improvement from bad days (baseline). | Baseline |
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Inclusion Criteria:
PATIENTS
PATIENT ADVOCATES:
Exclusion Criteria:
PATIENTS
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Patients with solid tumor and hematologic malignancy at Mayo Clinic, as well as patient advocates
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| Name | Affiliation | Role |
|---|---|---|
| Minji K. Lee, Ph.D., M.S. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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