Metabolic side effects of drugs and substances
Conditions
Interventions
The calculation to determine the sample size was based on a previous randomized clinical trial that also compared the effect of aerobic training compared to usual care on the deleterious effects of ch
Sponsors
Universidade Cidade de Sao Paulo
Instituto de Assistência Médica ao Servidor Público Estadual
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age; both genders; diagnosed with cancer and hospitalized in the Clinical Oncology ward of the Institute for Medical Assistance to State Public Servants, São Paulo-SP, to undergo at least one cycle of chemotherapy. Patients without musculoskeletal; cognitive or clinical limitations that interfere with the proposed evaluations and interventions, such as: heart diseases (moderate to severe aortic or pulmonary stenosis; decompensated heart failure; advanced cardiac arrhythmias; myocarditis; unstable coronary insufficiency, for example) will be included in the study; pneumopathies (chronic obstructive pulmonary disease and/or decompensated asthma, for example); diabetes mellitus; decompensated systemic arterial hypertension; serum hemoglobin (Hb) < 8g/dL or hematocrit (Ht) < 25% or platelets < 30,000 mm
Exclusion criteria
Exclusion criteria: Patients expected to be hospitalized for less than three days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find in the intervention group a reduction on the frequency and intensity of symptoms, such as: pain, nausea, dry mouth, related to chemotherapy evaluated by the Memorial Symptom Assessmet Scale, Brazilian version, (MSAS-BR). This scale consists of 32 symptoms that are scored by the patient according to their frequency and intensity (1-4 points, with 1 being the lowest intensity and frequency) and the discomfort (0-4, zero being no discomfort) that this symptom has caused. last week. This scale gives us a final index, which consists of the average of the three domains (frequency, severity and annoyance) and all items (TMSAS), in addition to four subscales: PSYCH, which assesses psychological symptoms (with six items), PHYS H, which assesses the most prevalent physical symptoms (with 12 items), PHYS L which assesses the least prevalent physical symptoms (with 14 items) and the Global Suffering Index (GDI) which contains four psychological and six physical symptoms. This scale will be applied in the initial and final evaluation by an evaluator who is blind to which group the patient belongs | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction will only be assessed in the intervention group, through the patient's subjective perception of the proposed protocol on the day of the final assessment. Patients will be asked two questions: "On a scale of 0 to 10, how satisfied are you with the exercise, with 0 indicating “total dissatisfaction” and 10, “maximum satisfaction.”; Next question: "On a scale of 0 to 10, what is your discomfort with the exercise, with 0 indicating “no discomfort” and 10, “maximum discomfort.” Patient satisfaction is expected to be high and discomfort low;It is expected to find in the intervention group, a reduction in fatigue assessed through the score in the Brazilian version of the brief fatigue inventory (BFI). This inventory consists of nine items that are rated from zero to ten on a numerical visual scale. The first question is a dichotomous question about whether the patient felt tired or fatigued in the last seven days. Three items refer to the severity of fatigue at the time of assessment, usual fatigue in the last 24 hours and worst fatigue in the last 24 hours, where zero represents no fatigue and ten “the worst imaginable fatigue”. The other six items are related to how fatigue interfered in different aspects of the patient's life in the last 24 hours, these items are: general activities, mood, ability to walk, work (including work outside and at home and daily tasks) , relationship with other people and enjoying life, where zero means that it does not interfere and ten means that it interferes completely. This inventory will be applied in the initial and final evaluation, by a blind evaluator to which group the patient belongs;It is expected to find in the intervention group, preservation in the mobility of patients evaluated by the score in the Brazilian version of the De Morton Mobility Index (DEMMI) scale. This scale is composed of 15 activities, where 11 of them are classified as zero or one (unable or able, respectively) and four are classified as | — |
Countries
Brazil
Contacts
Public ContactAdriana Lunardi
Universidade Cidade de Sao Paulo
Outcome results
None listed