CompletedEarly Phase 1

Fatigue and Pancreas and Bile Duct Cancer Study

United States100 participantsStarted 2009-01-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT00902759

SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01-07