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

Overview

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).

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

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.

Exclusion Criteria

Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
Patients being treated with hormonal therapy alone.

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
Rochester, Minn. Mayo Clinic principal investigator Jeff Sloan, Ph.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeff Sloan, Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials