Fatigue and Pancreas and Bile Duct Cancer Study

NCT00902759 | Completed Early Phase 1

• 3 other identifiers: 08D.5742008-37JT 1371
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Surgery; Chemotherapy; Radiation Therapy; Pancreatic cancer; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Usual Care Group

NO INTERVENTION

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.

Walking Program

EXPERIMENTAL

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.

Other: Walking Program

Interventions

Walking Program OTHER

"Brisk" walking is defined as faster than the slow walk, but not to exhaustion and not a running pace. Participants will be instructed to walk at home, at a gym or in a shopping mall for as far as possible on a level surface, wearing appropriate footwear as described in the walking booklet. (Patients may continue to walking longer if they desire and are symptom free). Participants should stop or slow down if they experience any discomfort (such as uncomfortable shortness of breath, chest pain, or body pain). The goal is to eventually walk for 90-120 minutes per week in three to four sessions. Participants will not be asked to take their pulse or to record their perceived exertion in order to simplify the program.

Walking Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Yeo 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 DERIVED

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Theresa Yeo, PhD, MPH, MSN, AOCNP

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: January 9, 2009
• Primary Completion: January 7, 2011
• Study Completion: April 15, 2015
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)