Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

Objectives: Assess the efficiency of physical activity upon controlling the fatigue and quality of life in patients with advanced stage of the disease at the end of 4 weeks using FACIT-F subscale, and test the feasibility of standardized exercise in patients with advanced cancer and conduct process evaluation including rates of recruitment and retention, attendance, satisfaction, barriers. Methods: This study will be a clinical trial and, provided the study informed consent has been signed, will count with the participation of 30 patients, from the Barretos Cancer Hospital Palliative Care unit, presenting fatigue ≥ 4 according to the of Edmonton Symptom Assessment Score (ESAS). All patients will undergo a 10-minute walk and exercises for the upper limbs with 1 lb-dumbbells, increasing the number of repetitions weekly, attending 5 sessions a week, during 4 weeks. A quality of life questionnaire, EORTC QLQ-30, FACIT-F, ESAS and Anxiety & Depression Hospital Anxiety Depression scale(HADS), will be filled out at the beginning, in the end of the 2 weeks and in end of the 4 weeks.

Objectives:

1 - Assess the efficiency of physical activity upon controlling the fatigue and quality of life in patients with advanced stage of the disease at the end of 4 weeks using FACIT-F subscale; 2.Assess the efficiency of physical activity upon QOL using EORTC QLQ-30; 3- To test feasibility of standardized exercise in patients with advanced cancer and conduct process evaluation including rates of recruitment and retention, attendance, satisfaction, barriers; 4- To determine the change in ESAS symptom distress score before and after treatment; 5 - Assess the efficiency of physical activity upon controlling the Anxiety and Depression.

Methods and Materials

Outlining the study A clinical trial study will be performed.

Population and place of study The study will assess 30 patients diagnosed with cancer having no chance of being healed and presenting fatigue ≥ 4 according to the ESAS, referred to by the outpatient department of the palliative care and pain unit from Pius XII Foundation - Barretos Cancer Hospital.

Methodology

After clarification and understanding of the research protocol and the consent in participating under formal demands outlined on Resolution 196/96 of the National Health Council/Brazil Health Ministry (1996) which provides about research involving human beings, patients are submitted to 5 weekly sessions of a 10 continuous minutes walk during 4 weeks in a 90-feet long corridor located at the palliative care unit and also a series of exercises for the upper limbs with 1 lb-dumbbells. Patients' will have monitored their blood pressure, heart/cardiac frequency ( 40-60% of HR RESERVE or 60-70% HR MAX) and oxygen saturation by way of a finger oximeter made by Digit and perceived effort = light sweating, increase HR and breathing. Dumbbell exercises during the first week will be 5 repetitions each, which will increase 5 repetitions per week, reaching a total of 20 repetitions on the last week. The exercises will be:

1. - shoulder flexion 0-180º;
2. - shoulder abduction and adduction;
3. - shoulder extension;
4. - elbow flexion;
5. - wrist flexion and extension;

Fatigue Evaluation Fatigue will be evaluated at the beginning ,in the end of the 2 weeks and in end of the 4 weeks. by a person trained by the researcher with a FACIT-F (primary outcomes) and ESAS FATIGUE. The FACIT-F questionnaire, which is subdivided in five subscales: physical well-being, social/family well-being, emotional well-being, functional well-being and additional worries. Each subscale is provided with questions that shall be answered with a single number that would best describe the answer to that question. The questionnaire Edmonton Symptom Assessment Score (ESAS) was originally prepared at the General Hospital Edmonton (Canada) and published in 1991. This instrument consists of nine symptoms: pain, fatigue, depression, anxiety, nausea, loss of appetite, well being and dyspnea. Each symptom can have its intensity measured on a scale ranging from 0 (no symptom) to 10 (the symptom in its strongest manifestation).

Anxiety and Depression Evaluation Anxiety and Depression will be evaluated at the beginning , in the end of the 2 weeks and in end of the 4 weeks. by a person trained by the researcher with a Anxiety & Depression Hospital Anxiety Depression scale(HADS). The HADS contains 14 multiple-choice questions, divided into two subscales: anxiety and depression, with seven items each. Each item has a score ranging from zero to three and overall range on each subscale ranges from zero to 21. Higher values indicate more symptoms of anxiety and depression20.

Quality of life Evaluation The quality of life of each patient will be evaluated at the beginning , in the end of the 2 weeks and in end of the 4 weeks through an interview held by a person trained by the researcher. In order to evaluate the quality of life of patients, an instrument developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) will be used; this instrument is called QLQ-C30 and is available in three versions.4 The EORTC QLQ-C30 version 3.0 validated for the Portuguese language presents 30 questions composed of both multi-item scales and single-item measures. These includes five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, pain and nausea and vomiting), and a global health status/QoL scale, and six single items commonly reported by people with cancer (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties), an assessment scale of the financial impact of the disease treatment.4 All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. QLQ-C30 has been designed so that all items in any scale take the same range of values. Most items are scored 1 to 4, giving range = 3. The exceptions will be the items that make up for the Global Health Status/QoL, which scores vary from 1 to 7, with a numerical difference equal to 6.

Study Variables The following will be collected: clinical/demographic characteristics, gender, age, skin color, marital status, level of schooling, diagnostic, onset of the disease, treatment performed.

Statistical Analysis Patients will be characterized through a descriptive analysis, by way of core tendency measures (mean and median) and dispersion (minimum and maximum standard deviation, and 95% confidence interval). Tests will be used for repeat measures, nonparametric data case, Wilcoxon test or parametric data, paired T-test. As statistical significance, a value of p<0.05 will be considered.

The SPSS program version 17.0 for Windows will be used for tabulation and data analysis.

Ethical Considerations This project was approved by the Ethical Committee in Research of the Pius XII Foundation - Barretos Cancer Hospital (Protocol 519/2011). Patients and witnesses, after being informed about the treatment applied and clarified about the aim of the study, will sign an informed consent. Thus, in this project, only the persons that signed the term of consent will participate.

Inclusion Criteria:

• Be older than 18 years of age,
• Any gender
• Able to understand the study protocol,
• Functional capacity equal to or higher than 60, according to the Karnofsky scale,
• Patients with a life expectancy between 3 and 12 months,
• Patient able to ambulate independently without need for any orthotics.

Exclusion Criteria:

• Patients that use drugs in order to control fatigue (Methylphenidate, Modafinil),
• Anemic Patients (HB< 8.0 mg/dl),
• Patients with cognitive deficit,
• Uncontrolled pain higher than 5, according to Visual Analogue Scale (VAS),
• Patients currently exercising,
• Patients with congestive heart failure (CHF) (New York Heart Association functional class III or IV) or related angina.