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

Study Overview
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Brief Summary
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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
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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. Patients take part in interview on study.

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

Conditions
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Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Non-Interventional Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unwilling to be audio recorded during the interviews Answered No for the screening question

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients take part in interview on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

What is the study measuring?
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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 |