A Comparison Study to Cross-validate the Linear Analogue Self-Assessment (LASA), Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Assessing Cancer Patient Well-being
Tab Title Description
Describes 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.
Sponsor Protocol Number: MC1294
About this study
This study is being done to compare questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), the Patient-reported Outcomes Measurement Information System (PROMIS) and the Linear Analogue Self-Assessment (LASA). These are questions which ask patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for future clinical trials. The study items have been developed under a contract from the National Cancer Institute (NCI).
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.
- Age ≥18 years.
- Patient has a diagnosis of cancer initiating active anti-cancer treatment (chemotherapy, targeted agents/biologics, surgery, and/or radiation therapy; hormonal therapy alone is not allowed) within the next 7 days or currently receiving active anti-cancer treatment (chemotherapy, targeted agents/biologics, and/or radiation therapy; hormonal therapy alone is not allowed) or underwent surgery for the treatment of cancer in the past 14 days.
- ECOG Performance Status (PS): 0-4.
- Ability to use and understand the informed consent and privacy protection documentation (written in English) and interact with the data collection modes (i.e., read and answer questions on a computer screen, listen to questions and respond using an IVR telephone system, or fill out a paper questionnaire).
- Provide written informed consent.
- Ability to participate in the study visit lasting 45-60 minutes total.
- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
- Patients being treated with hormonal therapy alone.
Publications are currently not available