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

NCT06104657 | Completed

• 3 other identifiers: 22-012283NCI-2023-00315FD 05938
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Observational Patient Group

Patients take part in interview on study.

Other: Non-Interventional Study

Observational Patient Advocate Group

Patient advocate participants take part in an interview on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational Patient Advocate Group; Observational Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• PATIENTS
• Unwilling to be audio recorded during the interviews
• Answered "No" for the screening question

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Minji K. Lee, Ph.D., M.S.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 27, 2023
• Study Start: May 31, 2023
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

US (1)