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Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients

Malignant Solid Neoplasm Clinical Trial

Official title:
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients

Clinical Trial 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 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06104657
Study type Observational
Source Mayo Clinic
Contact
Status Enrolling by invitation
Phase
Start date May 31, 2023
Completion date September 23, 2024
View Details
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