Clinical trial NCT03324620: Effectiveness Rehabilitation Hematopoietic Transplantation (ovERsHOT)
Official title: Cost-effectiveness of a Functional and Respiratory Rehabilitation Intervention in Patients Who Receive an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: physiotherapy
nurse
Cost effectiveness
Activities of Daily Living
exercise tolerance
Allogeneic
Quality of Life
Rehabilitation
Physical Activity
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 190
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Mixed study. Retrospective control group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Working hypothesis

* 1. Patients who receive a Hematopoietic Stem Cell Transplantation (HSCT) who follow a comprehensive rehabilitation program, have fewer post-transplant complications, reduce the number of hospital stay days, and return to their daily lives more quickly.
* 2. The economic costs derived from the incorporation of the rehabilitation program will be lower than the savings caused by the decrease in complications, hospital stay and consumption of health resources.

Goals

Main objectives

* To evaluate the quality of life related to health in the hematological patient who has received a HSCT and on which a new preventive functional rehabilitation intervention (other than physiotherapy) is applied.
* To compare the number and type of respiratory and other complications after HSCT among the intervention group compared to a control group.
* Estimate the effects of the rehabilitation program on tolerance to exercise in the short, medium and long term, as well as detect the change in lifestyle if this occurred.

Secondary objectives

* Evaluate and compare the days of hospital stay and the time elapsed in each of the specialized units (insulation, Intensive Care Unit, single room with High Efficiency Particulate Air, (HEPA filter).
* To qualify the economic costs of the physiotherapy intervention within the rehabilitation program, the complications and the days of hospitalization.
* To evaluate the incidence of muscular atrophy and the level of tolerance to the effort as indicative of physical deconditioning and sedentary lifestyle.
* Measure the amount of symptoms, or the frequency of them: pain (measured by visual analog scale for pain (VAS), nausea / vomiting, insomnia, anxiety, anorexia ...)

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:

* Bioimpedance analysis body composition (BIA), (Quantum X, RJL-Systems instruments™, Mi, USA): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months, in order to assess their body composition, their fat mass and their muscle mass.
* Six-minute-walk test (to complement the assessment of exercise tolerance): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months, in order to assess the exercise tolerance described in meters traveled, percentage of normality, symptomatology (dyspnea / fatigue of legs), and heart rate recovery. The abrupt weight changes in this population will be decisive for the interpretation of these data.
* Muscle strength test (handgrip (Jamar™ Dynamometer, Preston, Jackson, Mi, USA) and 1RM): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months, in order to assess the strength in upper limbs at different times of process.
* Functional Assessment of Cancer Therapy questionnaires (FACT) validated in Spanish, to measure quality of life associated with the disease (lymphoma (LYM), leukemia (LEU), multiple myeloma (MM), Bone marrow transplantation (BMT); fatigue, anorexia): This test is performed on the patients in the intervention group at baseline, at discharge from hospital for transplantation, at the month of discharge, and at 3, 6, and 12 months in order to evaluate subjectively different aspects of health: functional, physical, emotional, as well as other concerns and symptoms associated with the process.
* Physical activity questionnaire for adult subjects -Modified Baecke Questionnaire™- (to measure the sedentary lifestyle): This test is performed on the patients in the intervention group at baseline, at discharge from the transplant hospital, at the month of discharge, and at 3, 6, and 12 months, in order to subjectively assess physical activity which subjects can develop during the first year of the transplant, and if there are limitations due to complications or readmissions.
* Anxiety-depression assessment (HAD) questionnaire. This test is performed on patients in the intervention group at baseline, at discharge from the transplant hospital, at the month of discharge, and at 3, 6, and 12 months, in order to assess the role of anxiety and depression at different times of the transplant and its follow-up in one year.
* Pittsburgh Sleep Quality Index. This test is performed on the patients in the intervention group at baseline, at discharge from the transplant hospital, at the month of discharge, and at 3, 6, and 12 months, in order to assess the subjective quality of sleep in these patients during the transplant period and their follow-up for one year. It is intended to evaluate the previous present difficulties, the use of hypnotics or other drugs used, and the need for continuity of treatments, as well as the effectiveness of them. The quality of sleep in hospitalized patients is highly documented, but it is not present in this type of patients nor is there any longitudinal follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with malignant hemopathies candidates for HSCT.
* controlled pain.
* who sign informed consent.

Exclusion Criteria:

* Severe musculoskeletal or neurological alterations prior to HSCT.
* Severe psychiatric problems.
* Language barrier.

Primary outcomes:
measure: Cost of interventions assesed by the cost of hospitalization for HSCT
timeFrame: Admission
measure: Cost of interventions assesed by the cost incorporation of a physiotherapist into the team
timeFrame: Admission
measure: Cost of interventions assesed by the number (number), characteristics and incidence of the immediate complications of HSCT
timeFrame: Admisssion
measure: Cost of interventions assesed by antimicrobials used in infectious complications and chemotherapy conditioning.
timeFrame: Admission
Secondary outcomes:
measure: Adherence to the program and evaluation of the knowledge acquired by the patient.
timeFrame: Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: 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.)
timeFrame: Admission.
measure: 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.)
timeFrame: Admission.
measure: 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.)
timeFrame: Admission.
measure: 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.)
timeFrame: Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: 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.)
timeFrame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: Exercise tolerance
timeFrame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: Muscle atrophy: loss or gain of weight; measured by electrical bioimpedance
timeFrame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: Muscle atrophy: body mass index; measured by electrical bioimpedance
timeFrame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: Muscle atrophy: fat free mass index; measured by electrical bioimpedance
timeFrame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: Muscular atrophy measured by hand grip
timeFrame: Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.
measure: Mortality associated to HSCT
timeFrame: During the HSCT process, and up to a 2-year post HSCT follow-up.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic de Barcelona. Fundació Clinic per a la Recerca Biomédica.
name: Yolanda Torralba García, RN
role: PRINCIPAL_INVESTIGATOR
References: