Spots Global Cancer Trial Database for Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients

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Trial Identification

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

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

Study ID: NCT06104657

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Interventions

Non-Interventional Study

Study Description

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 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.