Pancreatic Cancer Clinical Trial
Official title:
Fatigue, Physical Functioning, and Quality of Life in Patients With Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy, and/or Radiation Therapy
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.
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 in patients undergoing CT and
RT, with fatigue the most universally reported symptom (Given, Given, McCorkle, Kozachik,
Cimprich, Rahbar, Wojcik, 20002). Fatigue can lead to a decrease in activity levels and in
one's overall QOL. Exercise has been found to effectively decrease fatigue levels and improve
functional capacity in patients with breast and prostate cancer (Mock, Pickett, Ropka, Lin,
Rhodes, McDaniel, et al. 2001; Segal, R., Reid, R., Courneya, K, Malone, S., Parliament, M.,
Scott, C., et al., 2003; MacVicar, Winningham, & Nickel, 1989).
No study to date has reported on the effects of an exercise program on fatigue levels,
physical functioning or QOL in post-operative pancreatic and periampullary cancer patients.
This pilot study will employ a quasi-experimental study design that is prospective in nature
and randomizes patients to either the intervention group or the usual care group.
Participants will complete the Piper Fatigue Scale (PFS) and the MOS SF-36 QOL questionnaire
post-operatively prior to hospital discharge or at the first office visit, and again at the
end of six months or at the conclusion of adjuvant treatment.
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