Clinical trial · Interventional
Fatigue and Pancreas and Bile Duct Cancer Study
Fatigue, Physical Functioning, and Quality of Life in Patients With Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy, and/or Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Walking Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care Group
- description
- Participants randomized to the usual care group will be encouraged to return to their "usual" or pre-surgical levels of activity. Usual care of post-surgical PC and peri-ampullary patients typically includes encouragement to walk and be active as they can be by the surgeons, surgical nurses and the nurse practitioners. Participants in the usual care group will not receive an individual "Exercise Prescription" at the time of entry. The usual care group will perform a baseline walk. Participants in the usual care group will not receive an individual "Exercise Prescription" at the time of entry nor will they will a telephone call every month. Repeat questionnaires will be performed at 6 months.
- type
- EXPERIMENTAL
- label
- Walking Program
- description
- Participants in the intervention arm will participate in a walking program consisting of a 6 week graduated walking program. There are three phases to the walking program, Phase 1 is Warm-up, Phase 2 is Brisk Walking and Phase 3 is Cool Down. Phase 1 is the same for all 6 weeks, and consists of a slow 5 minute walk. In Months 1 and 2, Phase 2 is a 10 minute brisk walk. In Months 3 and 4, Phase 2 is a 20 minute brisk walk. In Months 5 and 6, Phase 2 is a 25 - 30 minute brisk walk. Phase 3 is the same for all 6 weeks and consists of a 5 minute rest/cool down period.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214(4):463-75; discussion 475-7. doi: 10.1016/j.jamcollsurg.2011.12.017. Epub 2012 Feb 7. PMID 22321518