Clinical trial NCT06104657: Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Official title: Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid tumor and hematologic malignancy at Mayo Clinic, as well as patient advocates

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.

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.

Eligibility 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

Primary outcomes:
measure: Meaningful change in patient reported outcomes (PROs)
timeFrame: Baseline
measure: Change in Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores
timeFrame: Baseline
measure: Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Minji K. Lee, Ph.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: