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
Verified date | August 2017 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 15, 2015 |
Est. primary completion date | January 7, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 candidate) - Stage IV (metastatic) cancer |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires | 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. | 6 months |
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