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

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.

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