An interventional study of Specific program functional and respiratory rehabilitation in Hematopoietic Stem Cell Transplantation, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Prevention
The objective of the study is to evaluate the benefits and costs of a comprehensive rehabilitation program (physical, psychological, social and educational) for patients receiving hematopoietic stem cell transplantation (HSCT). It is a prospective longitudinal study with a control group. Patients will be included who will perform a transplant in the hospital environment. The variables of the study will be: number and type of complications, days of hospitalization, readmissions, economic cost of the program, exercise tolerance, assessment of muscular atrophy, health related quality of life, knowledge and self-management of the disease, all of them adjusted for the variables age, sex and hematological disease, as well as comorbidities. The evaluations will be performed before transplantation (between one and three months before), during the conditioning phase (intensive chemotherapy), before discharge, after immediate discharge and after discharge up to one year. The nursing team will perform the patient's therapeutic education, stimulation for physical activity, as well as evaluation and follow-up measures. Early detection of the needs of the rest of the rehabilitation team will be carried out. There will be a support function for the physiotherapist in regard to physical activity. In Spain there is no interdisciplinary team that provides comprehensive care and rehabilitation to this type of patients and few studies are dedicated to rehabilitation beyond physiotherapy as a preventive tool for future disabilities.
Working hypothesis
Goals
Main objectives
Secondary objectives
Methodology
This is a prospective experimental study with a control group prior to the start of the intervention, which will include 190 participants. The sample size was calculated using a 95% confidence level and considering a positive and negative variability of 50% since there are no previous studies applying this methodology and taking into account the high mortality associated with the infection that oscillates between 35 and 50% according to the studies. The subjects will be treated in the hospital setting in airtight rooms with HEPA filters. Patients will be collected correlatively from the moment they enter the transplant program and sign informed consent. The control group will be collected retrospectively, from the day 1 of the startup of the program to 75, after verifying that they do not meet any inclusion criteria. Recruitment and incorporation into the study will be continuous according to the appearance of cases that meet the inclusion criteria.
The study will include patients receiving HSCT for the next 2 years from the study start date and will be followed and evaluated for a period of one year after transplantation.
Outcomes:
Quality of life, post-transplant complications, especially respiratory, capacity for exercise tolerance, muscular atrophy, onset of sleep disorders, days of stay in different hospital units, cost of interventions: physiotherapy, treatment of complications, and program rehabilitation. Mortality related to the transplantation, which covers any lethal complication from the moment of conditioning and without intervening the patient's underlying disease, that is, the progression of the same. Assess adherence to the program and evaluation and knowledge acquired by the patient.
Measurements:
To make the measurements, use:
Exclusion Criteria:
Candidates for transplantation of hematopoietic progenitors since May 12, 2012, regardless of sex and age, who agree to participate in the study and sign informed consent. In the pre-transplantation visit with the physiotherapist: Measures of muscle mass and strength, quality of life questionnaires, program presentation, fitness assessment and lifestyle determination. The exercises will be personalized, stimulating your practice before admission and involving the family. During admission, the team will encourage the patient to remain active by adapting to the symptoms. At discharge, measures of resistance, exercise tolerance and quality of life at discharge, in the month after discharge, 3 months after discharge, 6 months after discharge and 12 months after discharge.
Other: Specific program functional and respiratory rehabilitation
Patients' candidates for transplantation of hematopoietic progenitors prior to May 12, 2012, regardless of gender and age, who meet the inclusion criteria and are collected correlatively until completing 104 subjects. Clinical history review to calculate the days of hospitalization in the different hospitalization units during the transplant. As well as the number and type of complications and the use of health resources. Status vitae. Baseline review of functional tests and exercise tolerance.
It is a question of introducing a small program of physical activation pre-transplantation of hematopoietic progenitors, to continue developing it during the hospitalization and to use the functional measurements as a measure of its impact, as well as the different quality of life questionnaires.
Cost of interventions assesed by the cost of hospitalization for HSCT
For the calculation the days of hospitalization in each hospitalization unit care are counted. Then, the total number of days spent in each unit (D): (intensive care unit, ICU (A), isolation chamber (B), single room (C). The cost of hospitalization for HSCT: (a: price / day in the ICU, b: price / day in isolation chamber, c: price / day in single room, in euros). Dd = (Aa) + (Bb) + (Cc), in euros.
Time frame: Admission
Cost of interventions assesed by the cost incorporation of a physiotherapist into the team
To calculate the cost, a physiotherapist will be hired 4 hours / day for the intervention group. Day of hospitalization for the transplant (D) multiplied by the cost per day of the physiotherapist (euros).
Time frame: Admission
Cost of interventions assesed by the number (number), characteristics and incidence of the immediate complications of HSCT
Incidence expressed as a percentage. Comparison between the two groups (total number and percentage)
Time frame: Admisssion
Cost of interventions assesed by antimicrobials used in infectious complications and chemotherapy conditioning.
expressed in euros
Time frame: Admission
Adherence to the program and evaluation of the knowledge acquired by the patient.
At each visit the patient will be purposely questioned about adherence to the exercise program. Non-adherence data will be collected, such as "I am bored with exercises", "I am very tired or have a lot of symptoms", "I am depressed or sad". In addition, each interview will gather training / information data explained in the previous interview. For example: Visit 1: adherence to treatment. Immunosuppressants. Importance of water intake. Neutropenic diet.
Time frame: Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) leukemia questionnaire (Scale info can be included in the description.)
Initially, the FACT (Functional evaluation of cancer therapy) questionnaire will be used according to the baseline disease: FACT_leukemia; (range 0-176 units on a scale). The highest scores in each category translate into a better quality of life. The questionnaire is divided into 4 sections: physical status (range 0-28 units), family and social environment (range 0-28 units), emotional state (range 0-24 units), operating capacity (range 0-28) and other concerns - leukemia-specific (range 0-68). The total score FACT_leukemia is the sum of all the sections. Also in the subsections the higher the score the better the perceived quality of life. The physical, environmental, emotional and functional capacity is common in all FACT questionnaires used, which allows comparing this aspect between subjects.
Time frame: Admission.
Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) lymfhoma questionnaire (Scale info can be included in the description.)
Initially, the FACT (Functional evaluation of cancer therapy) questionnaire will be used according to the baseline disease: FACT_lymphoma; (range 0-168 units on a scale). The highest scores in each category translate into a better quality of life. The questionnaire is divided into 4 sections: physical status (range 0-28 units), family and social environment (range 0-28 units), emotional state (range 0-24 units), operating capacity (range 0-28) and other concerns - lymfoma-specific (range 0-60). The total score FACT_lymfoma is the sum of all the sections. Also in the subsections the higher the score the better the perceived quality of life. The physical, environmental, emotional and functional capacity is common in all FACT questionnaires used, which allows comparing this aspect between subjects.
Time frame: Admission.
Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) multiple myeloma questionnaire (Scale info can be included in the description.)
Initially, the FACT (Functional evaluation of cancer therapy) questionnaire will be used according to the baseline disease: FACT_multiple myeloma; (range 0-164 units on a scale). The highest scores in each category translate into a better quality of life. The questionnaire is divided into 4 sections: physical status (range 0-28 units), family and social environment (range 0-28 units), emotional state (range 0-24 units), operating capacity (range 0-28) and other concerns - myeloma-specific (range 0-56). The total score FACT_multiple myeloma is the sum of all the sections. Also in the subsections the higher the score the better the perceived quality of life. The physical, environmental, emotional and functional capacity is common in all FACT questionnaires used, which allows comparing this aspect between subjects.
Time frame: Admission.
Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) Bone marrow transplant (Scale info can be included in the description.)
The questionnaire is divided into 4 sections: physical status (range 0-28 units), family and social environment (range 0-28 units), emotional state (range 0-24 units), operating capacity (range 0-28) and other concerns - bone marrow transplantation (range 0-40). The total score FACT_BMT is the sum of all the sections. Also in the subsections the higher the score the better the perceived quality of life. The physical, environmental, emotional and functional capacity is common in all FACT questionnaires used, which allows comparing this aspect between subjects.
Time frame: Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Referred quality of life: Levels of anxiety and depression will also be assessed using the Hospital Anxiety and Depression Scale (HAD) questionnaire. (Scale info can be included in the description.)
It is a self-applied questionnaire of 14 items, consisting of two subscales of 7 items, one of anxiety (odd items) and one of depression (even items). The items of the subscale of anxiety avoiding the inclusion of physical symptoms that can be confused by the patient with the symptomatology proper to his physical illness. The items on the depression subscale focus on the area of anhedonia (loss of pleasure) The score range is 0-21 for each subscale, and 0-42 for the overall score. More than 11 points for each subscale show a clinical problem. Global cutoffs are more controversial depending on the underlying disease.
Time frame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Exercise tolerance
measured by 6 minutes walking test
Time frame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Muscle atrophy: loss or gain of weight; measured by electrical bioimpedance
Gain or loss of weight with respect to the reference visit in kg.
Time frame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Muscle atrophy: body mass index; measured by electrical bioimpedance
Body mass index expressed in kg / m². The weight (in kg) and the height (in meters) will be used for the calculation and will be combined in the formula (weight in kg / height in m \^ 2). According to the WHO, it is considered underweight: \<18.5; normal weight: 18.5-24.9; overweight: 25-29.9; degree of obesity I: 30.0-34; 5; degree of obesity II: 35.0-39.9; obesity grade III:\> 40.
Time frame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Muscle atrophy: fat free mass index; measured by electrical bioimpedance
The fat-free mass index (kg / m²) shall be calculated as non-fat body mass (in kg) x height (in meters) \^ 2. Poor physical fitness is considered in males \<18 kg / m², and in females \<13.5 Kg / m².
Time frame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Muscular atrophy measured by hand grip
Strength in the upper limbs expressed in kg.
Time frame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
Mortality associated to HSCT
Clinical History review.
Time frame: During the HSCT process, and up to a 2-year post HSCT follow-up.
Plan to share: No
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Hospital Clinic of Barcelona