Clinical Trial: Fatigue and Pancreas and Bile Duct Cancer Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Fatigue, Physical Functioning, and Quality of Life in Patients With Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy, and/or Radiation Therapy

Brief Summary: The purpose of this pilot study is to determine the effects of a walking program on fatigue, physical functioning and QOL in patients with pancreatic and periampullary cancers who have had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation therapy (RT). This pilot study will utilize the walking program developed by Mock et al. (2001), in their investigation of the improvement of fatigue and QOL in breast care patients following surgery who were receiving CT, RT or biotherapy. No studies published to date have utilized a progressive walking program in post-operative pancreas and ampullary cancers to determine if it reduces adverse effects, such as fatigue or improves functionality and QOL scores.

Detailed Summary:

Pancreatic cancer (PC) is the fourth leading cause of cancer death in men and fifth in women in the US (Jemal, Sigel, Ward, Murray, Xu, Thun et al., 2007). According to the American Cancer Society, the reported incidence of PC is roughly 37,000 cases per year, with approximately 33,000 annual deaths (2007). Periampullary cancers are less common; there were 9,250 incident cancers of the biliary tract in 2007, with 3,250 resultant deaths (Jemal et al., 2007).

Five-year survival rates for untreated PC and periampullary cancers are poor, approximately 4%. Surgery offers the only hope of a cure for these patients. Following resection, the reported median survival is 12-18 months, with a five-year survival of 10-40% for patients with PC (Cleary, Gryfe, Guindi, 2004; Ishikawa, Ohihashi, Yamada, Sasaki, Imaoka, Nakaizumi et al., 2002; Sohn, Yeo, Cameron, Koniarais, Kaushal, Abrams, et al., 2000; & Conlon, Klimstra, & Brennan, 1996) and somewhat higher rates for patients with periampullary cancers. Five-year post-resection survival rates may approach 40% when performed at specialized major medical institutions and when favorable pathologic predictors are identified (Sohn et al.). In recent years, improved post-resection survival is due in part to lower perioperative mortality, and partially due to aggressive resection of early, low stage tumors. Long-term survival is considerably lower when resection is performed at low volume pancreatic surgery institutions and postoperative mortality is significantly higher (Birkmeyer, Siewers, Finlayson, Stukel, Lucas, Batista, et al., 2002).

As patients with pancreatic and periampullary cancers experience improved survival rates and live longer, issues regarding adverse symptoms, physical function and quality of life become more important. Fatigue and pain are commonly reported symptoms
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome: FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires [ Time Frame: 6 months ]

Original Primary Outcome: FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires [ Time Frame: questionnaires will be completed after surgery but prior to initiation of CT or RT and again 6 months after hospital discharge or at the completion of adjuvant therapy ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Thomas Jefferson University

Dates:
Date Received: May 13, 2009
Date Started: February 2009
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016