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

Phase 0
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

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.

Inclusion Criteria:

- Confirmed pathologic diagnosis of adenocarcinoma of pancreas or periampullary
cancers, Stage I, II, or III

- Treatment included surgery alone, or adjuvant treatment with CT and/or RT

- Men and women ≥ 18 years of age

- Residents of the USA

- Surgery performed at TJUH, Philadelphia, PA

- CT or RT performed at TJUH, Jefferson system affiliate hospital, or elsewhere

- Patients receiving neoadjuvant therapy with CT or RT, or both, who subsequently are
re-staged and eligible for surgery

Exclusion Criteria:

- The presence of co-morbidities that would preclude involvement in a walking program
(wheelchair bound, severe arthritis, dizziness)

- Primary residence outside the USA

- Medical management alone for pancreas or periampullary cancer (i.e. not a surgical

- Stage IV (metastatic) cancer

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires

Outcome Description:

Questionnaires will be completed after surgery but prior to initiation of chemotherapy (CT) or radiation therapy (RT) and again 6 months after hospital discharge or at the completion of adjuvant therapy.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Theresa Yeo, PhD, MPH, MSN, AOCNP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Cancer
  • Surgery
  • Chemotherapy
  • Radiation Therapy
  • Pancreatic cancer
  • Fatigue
  • Fatigue
  • Pancreatic Neoplasms
  • Bile Duct Neoplasms



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541