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

Completed

• Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06104657
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2023-05-31
• Primary Completion: 2023-08-07
• Study Completion: 2023-08-07
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• PATIENTS

  • 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

• PATIENTS

  • Unwilling to be audio recorded during the interviews
  • Answered "No" for the screening question

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Patient Advocate Group	Non-Interventional Study	Patient advocate participants take part in an interview on study.
Observational Patient Group	Non-Interventional Study	Patients take part in interview on study.

Primary Outcome Measures

Name	Time	Method
Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores	Baseline	The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that measures four domains of Health-Related Quality of Life (HRQOL) in cancer patients: physical, social, emotional, and functional well-being. Questions are answered with a 0-4 scale where 0=Not at all and 4=Very much. Scores will be evaluated for worsening from good days (baseline) and improvement from bad days (baseline).
Meaningful change in patient reported outcomes (PROs)	Baseline	Change in PROs will be assessed using the critical incident technique (CIT) during semi-structured interviews as a means of educating, training, and evaluating patients on the concept of meaningful change. Interviews will be summarized to record how patients explain the concept of meaningful improvement and declines in their own words.
Change in Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores	Baseline	PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE). Scores will be evaluated for worsening from good days (baseline) and improvement from bad days (baseline).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States