Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Fatigue

Stomach Neoplasms

Stomach Cancer

education and education and walking program design

walking

Shiow-Ching Shun, Ph.D

The aims of this three-year study are to:

1. develop and validate a perceived meaning of fatigue scale
2. examine the effect of individualized patient education and walking programs on alleviating fatigue in patients with gastric or colorectal cancer,and further explore the relationship between the perceived meaning of fatigue and intervention outcome.

In the first year, patients will be recruited from oncology inpatient wards and outpatient clinics in two medical center hospitals in Taipei. Purposive sampling will be used to recruit outpatients or inpatients receiving chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, one-way analysis of variance, and exploratory factor analysis.

In the second and third years, an experimental design consisting of three groups including a control group, an education only group, and an education and walking program group will be used. Data will be collected at treatment weeks 1, 4,8,12,16 including three cycles of chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, and generalized estimating equations. At least 230 subjects will be interviewed in the first year.

At least 105 of patients with gastric cancer or colorectal will be classified into the three groups in the second and third year. We expect the results of this study to explore the meaning of fatigue and to help develop a common strategy to manage fatigue in Taiwan. The results can help clinicians and researchers to tailor interventions for cancer patients with severe fatigue.

Development and Validation of Perceived Fatigue Meaning Scale on Walking Program

Development and Validation of Perceived Fatigue Meaning Scale and Its Effect on Individualized Patient Education and Walking Program for Managing Fatigue in Patients With Cancer

the level of fatigue in three groups will be measured at the end of intervention

National Science Council, Taiwan

National Taiwan University Hospital

Shiow-Ching Shun/ Assitant Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The exercise in this study will consist of two types of exercise training: resistance training and aerobic exercise. Resistance training is like "weight lifting" to improve strength and function. Participants will complete resistance training by using resistance machines and free weights. Aerobic exercise is exercise that intends to improve the cardiopulmonary or oxygen/lung and heart systems. It is often referred to as "cardio" exercise. Treadmill walking, stationary cycling sessions, and/or other exercises will be used for aerobic exercise.

Participants will be instructed in the exercise routine by physical fitness experts and trainers.

First 20 Weeks: Participants will take part in a structured Health Education and Support Group sessions once a week.

Last 32 weeks: Participants will be encouraged to take part in any of the Support Group sessions offered regularly on their own schedule.

Supervised aerobic training for 40 minutes 3x/week for 20 weeks

Aerobic Training - Fixed Schedule

Supervised resistance training for 20 minutes 3x/week for 20 weeks

Resistance Training - Fixed Schedule

Unsupervised walking program 1-3 days/week for 52 weeks

Walking program

Supervised aerobic training done on the participant's own schedule for 32 weeks

Aerobic Training - Flexible Schedule

Supervised resistance training done on the participant's own schedule for 32 weeks

Resistance Training - Flexible Schedule

Support groups will be held for one hour 3x/week for 20 weeks. Topics will include, but are not limited, to long-term side effects of treatment, stress management, coping with fear and uncertainty, body image, sexuality, and spirituality.

Successful Survivorship Health Education and Support Group

Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.

Flexible support groups

Cynthia Owusu, MD

The purpose of this research study is to determine whether a physical activity (exercise) program in the community will improve the functional and overall health status of older women with a history of breast cancer. The physical activity or exercise program is designed for all older breast cancer survivors, and in particular for African-Americans and women of lower socio-economic status, who are the least likely to engage in physical activity.

Specific Aim #1: To determine the effect of a refined and culturally-sensitive physical activity intervention on functional outcomes at 20 and 52 weeks among older Breast Cancer survivors who are within five years of treatment completion for stage I-III Breast Cancer (BCa).

Specific Aim #2: To examine whether race and socioeconomic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks.

Specific Aim #3: To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes and preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.

Specific Aim #4: To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.

Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors

A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors

Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.

Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

National Institutes of Health (NIH)

Case Comprehensive Cancer Center

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Cholangiocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

Bile Duct Cancer

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Gastrointestinal Agents

Vitamins

Vitamin A

Retinol palmitate

Pancrelipase

Pancreatin

Retinol

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.

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.

"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

Theresa Yeo, PhD, MPH, MSN, AOCNP

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.

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development and Validation of Perceived Fatigue Meaning Scale on Walking Program	NCT01178775	Gastric Cancer	walking	20 Years -	National Taiwan University Hospital
Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors	NCT02763228	Breast Cancer Physical Activi...	Aerobic Trainin... Resistance Trai... Walking program Aerobic Trainin... Resistance Trai... Successful Surv... Flexible suppor...	65 Years -	Case Comprehensive Cancer Center
Fatigue and Pancreas and Bile Duct Cancer Study	NCT00902759	Pancreatic Canc...	Walking Program	18 Years -	Thomas Jefferson University

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