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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with solid tumor and hematologic malignancy at Mayo Clinic, as well as patient advocates

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Patient Group; Patients take part in interview on study.	Other: Non-Interventional Study; Non-interventional study
Observational Patient Advocate Group; Patient advocate participants take part in an interview on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meaningful change in patient reported outcomes (PROs)	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.	Baseline
Change in Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores	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).	Baseline
Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores	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).	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Minji K. Lee, Ph.D., M.S., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 22-012283 (Other Identifier: Mayo Clinic in Rochester); NCI-2023-00315 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); FD 05938 (Other Grant/Funding Number: Food and Drug Administration)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No