This randomized clinical trial studies how well symptom management works in improving symptom burden in patients with gynecologic cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment or that has come back and are receiving chemotherapy. Palliative chemotherapy may help patients with advanced gynecologic cancer live more comfortably. Screening patients receiving chemotherapy may help identify palliative care needs and determine which symptom management option provides the best improvement in symptom burden and may result in improved quality of life.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02786524.
PRIMARY OUTCOMES:
I. To evaluate whether referral to outpatient symptom management and support clinic affects symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.
OUTLINE:
All patients complete Baseline Patient Palliative Care Survey, revised Edmonton Symptom Assessment System (ESAS‐r) and National Comprehensive Cancer Network (NCCN) Distress tool, every three to four weeks based on their chemotherapy appointments. Patients scoring 5 or higher on the Baseline Patient Palliative Care Survey are then randomized to 1 of 2 arms.
ARM I (FORMAL REFERRAL TO SYMPTOM MANAGEMENT AND SUPPORTIVE CARE CLINIC): Patients receive formal referral to Symptom Management and Supportive Care clinic and are seen every 3-4 weeks coinciding with their chemotherapy appointments or more frequently as clinically indicated based on the Symptom Management and Supportive Care clinicians’ recommendation.
ARM II (STANDARD CARE): Patients receive standard of care (symptom management by the patient’s gynecologic oncologist).
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorCarolyn M. Johnston
