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

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

NCT ID: NCT06104657

Condition: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm

Conditions: Official terms:
Neoplasms

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Non-Interventional Study
Description: Non-interventional study
Arm group label: Observational Patient Advocate Group
Arm group label: Observational Patient Group

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Start date: May 31, 2023

Completion date: September 23, 2024

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06104657
https://www.mayo.edu/research/clinical-trials