Clinical trial · Observational
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
NCT06104657CI-TRIAL-00083164completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Observational Patient Group
- description
- Patients take part in interview on study.
- interventionNames
- Other: Non-Interventional Study
- label
- Observational Patient Advocate Group
- description
- Patient advocate participants take part in an interview on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (3)
- measure
- Meaningful change in patient reported outcomes (PROs)
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.