Status:
COMPLETED
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
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 n...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- PATIENTS
- Patients with a diagnosis of cancer including solid tumor and hematologic malignancy at Mayo Clinic, Rochester
- To ensure sampling patients likely to have experienced declines in fatigue, all patients will have had at least two in-person encounters for radiation or chemotherapy treatment within the 3 months prior to recruitment. The sampling methodology developed for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey will be modified and used to identify eligible patients from Mayo Clinic's electronic health record
- As interviews will be conducted either in person or by video conference (Zoom, Teams, or similar), access to internet is required for those unable or unwilling to travel to the clinic for an in-person interview
- Answered "Yes" to screening question: "In the past 3 months, have you experienced changes in your level of fatigue?" Yes/No
- PATIENT ADVOCATES:
- Patient advocates recommended by the FDA to provide their input to help us in reaching a consensus in the way we define meaningful change (both improvement and decline) that came from patients in the first arm
Exclusion
- PATIENTS
- Unwilling to be audio recorded during the interviews
- Answered "No" for the screening question
Key Trial Info
Start Date :
May 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06104657
Start Date
May 31 2023
End Date
August 7 2023
Last Update
December 2 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905