Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
NCT ID: NCT06104657
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2023-05-31
2023-08-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational Patient Group
Patients take part in interview on study.
Non-Interventional Study
Non-interventional study
Observational Patient Advocate Group
Patient advocate participants take part in an interview on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Unwilling to be audio recorded during the interviews
* Answered "No" for the screening question
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Minji K. Lee, Ph.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-00315
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-012283
Identifier Type: OTHER
Identifier Source: secondary_id
FD 05938
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
22-012283
Identifier Type: -
Identifier Source: org_study_id