Survey Study on Patient Reported Outcomes for Small Cell Lung Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 22-002138
Sponsor Protocol Number: 20208
About this study
The purpose of this study of adults who have been diagnosed with SCLC aims to gain a better understanding of participants’ experiences with SCLC symptoms and impacts, and to refine a patient-reported outcome (PRO) measure, the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ©), for use in future trials of SCLC treatments.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Is at least 18 years of age.
- Has a clinician-confirmed diagnosis of limited or extensive stage SCLC.
- Has an ECOG Performance Status of 0 to 3 at the time of screening.
- Can read, write, and speak English well enough to understand and complete the informed consent form (ICF), take part in the interview process, and complete all study procedures.
Exclusion Criteria:
- Has a clinically significant1 current or past history of a personality disorder, bipolar disorder, schizophrenia or other psychotic disorder, obsessive compulsive disorder, cognitive disorder, post-traumatic stress disorder, or intellectual disability.
- Has a recent (12-month) history of clinically significant1 drug or alcohol abuse or dependence, excluding nicotine.
- Has been hospitalized for COVID-19 within the previous 12 weeks or, at the time of study screening, is experiencing unresolved COVID-19 symptoms from a current or prior case of COVID-19 as any medical condition or disorder (e.g., symptomatic brain metastases; significant cognitive, auditory, or visual impairment) that, in the opiniHn of the site investigator or study director, could compromise participant’s ability to give written informed consent and/or prevent or interfere with his or her ability to comply with study procedures and provide meaningful information about his or her SCLC experience.
Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Terence Sio, M.D., M.S. |
Closed-enrolling by invitation |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available