NCT06104657

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 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

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2023-05-31
• Primary completion: 2023-08-07
• Completion: 2023-08-07
• First posted: 2023-10-27
• Last updated: 2024-12-02

Locations

1 site across 1 country: United States