Hematopoietic and Lymphoid System NeoplasmNCT06104657
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
An observational study of Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 7 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with solid tumor and hematologic malignancy at Mayo Clinic, as well as patient advocates
Who may be able to join
- 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
Who cannot join
- PATIENTS
- Unwilling to be audio recorded during the interviews
- Answered "No" for the screening question
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational Patient Group | Patients take part in interview on study. Receives: Other: Non-Interventional Study | |
| Observational Patient Advocate Group | Patient advocate participants take part in an interview on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start31 May 2023
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minji K. Lee, Ph.D., M.S., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104657
- Sponsor's protocol ID
- 22-012283
- Other IDs
- NCI-2023-00315, 22-012283, FD 05938
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT06104657
- Acronym / sponsor ID
- 22-012283
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Patient Group | – | Other: Non-Interventional StudyPatients take part in interview on study. |
| Observational Patient Advocate Group | – | Other: Non-Interventional StudyPatient advocate participants take part in an interview on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumor and hematologic malignancy at Mayo Clinic, as well as patient advocates
Key inclusion criteria (7 listed)
- PATIENTS
- PATIENT ADVOCATES:
Key exclusion criteria (3 listed)
- PATIENTS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational Patient Advocate Group, Observational Patient Group |
Primary outcome
Meaningful change in patient reported outcomes (PROs)
Time frame: Baseline
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.
Change in Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores
Time frame: Baseline
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).
Change in Functional Assessment of Cancer Therapy - General (FACT-G) scores
Time frame: Baseline
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minji K. Lee, Ph.D., M.S. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meaningful change in patient reported outcomes (PROs) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.