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

Mayo Clinic

Status: Completed

Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06104657

22-012283 (Other Identifier)

FD 05938 (Other Grant/Funding Number)

NCI-2023-00315 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Observational Patient Group

Description:

Patients take part in interview on study.

Treatment:

Other: Non-Interventional Study

Observational Patient Advocate Group

Description:

Patient advocate participants take part in an interview on study.

Treatment:

Other: Non-Interventional Study