One-year survey of symptoms experienced by patients being treated for advanced or metastatic cancer

Study ID: AFT-39

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

In this study, researchers seek to determine whether systematic monitoring of symptoms via patient-reported outcome (PRO) measures during routine, outpatient, cancer-care delivery improves meaningful clinical outcomes.

Symptoms are common during cancer treatment, but they frequently go undetected by clinicians between visits. As such there is substantial and growing interest to integrate PROs into routine practice to improve detection and management of patients’ symptoms.

Patient self-reporting of symptoms—with alerts to clinicians for severe symptoms—offers a potential approach to flag concerning symptoms and prevent complications. The study is designed to test whether patients’ outcomes and utilization of services can be improved through symptom monitoring via PROs between visits.

Participants complete questionnaires electronically, either in their homes or at Main Line Health. Questionnaires can also be completed on paper in the clinic, if needed. Patients complete the questionnaires upon enrollment, and then at the following months: 1, 3, 6, 9, and 12. The questionnaires are available in English, Spanish or Mandarin Chinese.

The study is designed to test whether cancer patients’ outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.

Whenever a concerning symptom is reported by a trial participant, an automated email alert notification will be sent to the clinical trial coordinator (and Nurse Champion, if applicable), who will forward the alert to the responsible clinical nurse (or other covering clinician). Within 72 hours, the coordinator will document what action(s), if any, were taken by the nurse in response to the alert.

Exclusion criteria:

  • Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma) or receiving hormonal therapy
  • Patients diagnosed with leukemia or indolent lymphoma
  • Patients already participating in a clinical study

Inclusion Snapshot

  • Must be at least 21 years old and have been diagnosed with advanced or metastatic cancer of any type, except leukemia or indolent lymphoma
  • Must be undergoing outpatient cancer treatment with palliative/non-curative intent (e.g., chemotherapy, targeted therapy, immunotherapy)
  • Must not be undergoing treatment with curative intent or hormonal therapy

Contact Information

Lankenau Institute for Medical Research trial