The New PC-SAF Instrument: A Patient-Reported Outcome Tool for Identifying the Symptoms of Pancreatic Cancer

June 2015, Vol 6, No 5

Philadelphia, PA—The prognosis for patients with pancreatic cancer, the leading cause of cancer-related deaths in the United States, remains poor. The diagnosis of pancreatic cancer is often delayed to a late stage, which affects impact. Improving the understanding of the early signs and symptoms of this cancer may improve outcomes.

Patient-reported outcome tools have been shown to help determine the key signs, symptoms, and impact of a disease, but there are currently no patient-reported outcomes instruments for pancreatic cancer. In an effort to fill this need, investigators developed the new Pancreatic Cancer Symptom Assessment Form (PC-SAF), a new daily electronic diary instrument containing a preliminary set of patient-reported outcome items for patients with pancreatic cancer.

Diane M. Turner-Bowker, PhD, MA, Engagement Leader, Advisory Services, Quintiles, Cambridge, MA, and colleagues, reported on encouraging results of this new PC-SAF tool ­at the 2015 International Society for Pharmacoeconomics and Outcomes Research annual international meeting.

Dr Turner-Bowker and colleagues sought to assess a content-validated patient-reported outcomes tool, the PC-SAF, using face-to-face, open-ended qualitative and cognitive interviews with adults with advanced metastatic pancreatic cancer. They conducted qualitative interviews with 18 patients and explored the important signs, symptoms, and impact of pancreatic cancer. They further measured the saturation of concept and inter-rater agreement to assess the quality of the collected data.

The investigators conducted cognitive interviews with 14 patients, and examined the patients’ understanding of, and ability to respond to, electronically administered PC-SAF items.

Predominant Signs and Symptoms of Pancreatic Cancer

Based on the patients’ responses to the qualitative interviews, the predominant signs and symptoms reported by patients with pancreatic disease included:

  • Gastrointestinal symptoms, including loss of appetite, early satiety, gas/bloating, constipation, diarrhea, nausea, and vomiting
  • Pain and discomfort, particularly in the abdomen
  • Tiredness/low energy level
  • Weight loss.
Furthermore, the patients reported difficulties with:
  • Activities of daily living
  • Physical difficulties (eg, limitations in walking, standing, climbing stairs)
  • Social difficulties
  • Dietary changes
  • Emotional problems, especially depression.

New Tool Validated

Dr Turner-Bowker and colleagues noted that their study “findings support the content validity of the PC-SAF, a new instrument that includes PRO [patient-reported outcome] items to assess the key signs, symptoms, and impacts experienced by adults with pancreatic cancer.”

Overall, the inter-rater agreement and the quality of the collected data were strong, and the patient responses to the qualitative interviews helped to fine-tune the contents of the PC-SAF tool.

The PC-SAF items were generally well-understood, and overall, the patients considered the PC-SAF easy to use. However, the researchers did slightly modify the wording and included colloquial terms to enhance the use of the PC-SAF tool by all patients, and to improve clarity of this type of cancer.

The PC-SAF Tool in Clinical Trials

The PC-SAF instrument is currently being used in a phase 3 clinical trial of patients with advanced or metastatic pancreatic cancer to compare the benefits of ruxolitinib (Jakafi) plus capecitabine (Xeloda) versus capeci­tabine plus placebo in this patient population; the PC-SAF tool is being used to assess the change from baseline in the symptoms reported by patients with pancreatic cancer.

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