This trial evaluates a symptoms assessment and management program and and enhanced care approach for patients with cancer. The Cancer Center Symptom and Needs Assessment questionnaire is part of routine care and helps the cancer team to identify patients' symptom management needs. This trial is being done to test the impact of a system wide symptom management intervention and a patient-engagement, enhanced care approach. Reporting symptoms via a symptom assessment and management program may improve the speed and extent to which symptoms are able to be addressed by health care providers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03988543.
PRIMARY OBJECTIVE:
I. To evaluate the impact of the enhanced care program (EC: symptom monitoring & self-management intervention), relative to usual care (UC) on patient- and system-level outcomes.
OUTLINE: Patients are assigned to 1 of 2 groups.
PRE-IMPLEMENTATION: Patients complete standard symptom and needs assessment questionnaires once a month for 1 year.
RANDOMIZED COHORTS: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual care consisting of completing standard symptom and needs assessment questionnaires once a month for 1 year.
ARM II: Patients complete standard symptom and needs assessment questionnaires once a month for 1 year. Patients also receive additional information on managing symptoms.
POST-IMPLEMENTATION: Patients participate in focus group at 5 and 14 months post-implementation.
After completion of study, patients are followed up periodically.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorDavid Cella
