About the Meeting

NCI Symptom Management and Quality of Life (SxQOL) Steering Committee (SC) Clinical Trials Planning Meeting on Building Bridges


In 2001, the NCI created the Cancer Outcomes Measurement Working Group (COMWG) consisting of 35 experts convened to examine the state of the science and identify future priorities for outcomes assessment in cancer research. After an extensive review of the cancer outcomes research field over the previous two decades, the COMWG, found that assessing health-related quality of life (HRQOL) and symptom burden is feasible using questionnaires that meet established criteria for reliability and validity. Building on the COMWG findings, the NCI sponsored an international conference in 2006 entitled, "Patient-Reported Outcomes Assessment in Cancer Trials (PROACT): Evaluating and Enhancing the Payoff to Decision Making." The meeting resulted in a 2007 JCO monograph which identified significant issues and challenges for the incorporation of patient-reported outcomes (PROs: includes HRQOL and symptom burden) in cooperative group trials. Among them was the recognition of the potential for patient-reported symptoms to enhance adverse event monitoring in cancer trials.

Both the COMWG and PROACT reported that a key impediment to move the field forward is a lack of universally recognized standard set of PRO domains to routinely be collected in cancer trials. Clinical trial investigators struggle with the task of knowing what domains to measure in their study that would inform the understanding of the safety and efficacy of the intervention under investigation. The literature is vast on this topic, yet there lacks one source where consensus has been reached on the key PRO domains. As a result, investigators may drop consideration of a PRO endpoint or spend significant time up front to review the literature, consult with co-investigators, and agree on measured endpoints. Further, there lacks consistency from one study to the next on what PRO endpoints are measured which reduces our ability to compare or combine results across trials.

The goals of the NCI SxQOL SC Clinical Trials Planning Meeting on Building Bridges: The Identification of Core Symptom and Health-Related Quality of Life Domains for use in Cancer Research are to:

  1. Identify a standard core set of patient-reported symptoms and/or health-related quality of life (HRQOL) domains to be assessed in clinical trials with cancer patients. Selected symptom and HRQOL domains should be ones that are commonly experienced across cancers and are helpful to inform clinical research findings and policy decisions.
  2. Identify a core set of symptoms and/or HRQOL domains that should be assessed in clinical trials that include patients with either a head and neck cancer, prostate cancer, or gynecological cancer.
  3. Identify patient-reported questionnaires that are appropriate to capture relevant symptoms and HRQOL domains selected in goals 1 and 2.

To accomplish these goals we will bring together a group of experts in PRO measurement, experts in the use of PROs in cooperative group trials, Disease Site Chairs and Symptom Management Quality of Life Liaisons of the NCI Steering Committees, Cooperative Group Chairs, pharmaceutical PRO experts, FDA representatives, and NCI representatives, as well as patient advocates. The deliverables from this meeting will be a listing of core domains to be collected specific to the conditions experienced by individuals with head and neck cancers, prostate cancer, and gynecological cancers, and core domains to be collected across all cancers and/or by treatment type. With each core domain, links will be provided to existing questionnaires that can be successfully used with cancer patients. This resource will have incredible value for investigators to save them time for searching for this information and to provide a link to review committees to support their selection of both endpoints and measures. Thus, the products from this meeting will set forth a future research agenda for greater integration of PRO measures in cancer research.