Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT06104657
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2023-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: