Cancer Clinical Trial
Official title:
Interdisciplinary Randomized Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney
Hypothesis: Oncological patients presenting with respiratory problems will benefit both at a
functional level and at a level of quality of life from the inclusion of a program of
integral respiratory rehabilitation from the perspective of nursing and occupational therapy
at the time of admission hospital for an exacerbation of his respiratory symptoms.
Main objective: to verify the effectiveness of a comprehensive respiratory rehabilitation
program carried out from the perspective of an interdisciplinary team made up of nurses,
occupational therapists and doctors in the improvement of the respiratory problem referred to
oncological disease.
Design: experimental, randomized, stratified, longitudinal prospective study through a
parallel scheme of fixed assignment with experimental group and control group.
Hypothesis: Oncological patients presenting with respiratory problems will benefit both at a
functional level and at a level of quality of life from the inclusion of a program of
integral respiratory rehabilitation from the perspective of nursing and occupational therapy
at the time of admission hospital for an exacerbation of his respiratory symptoms.
Main objective: to verify the effectiveness of a comprehensive respiratory rehabilitation
program carried out from the perspective of an interdisciplinary team made up of nurses,
occupational therapists and doctors in the improvement of the respiratory problem referred to
oncological disease.
Design: experimental, randomized, stratified, longitudinal prospective study through a
parallel scheme of fixed assignment with experimental group and control group.
Location: Medical Oncology Service of the University Hospital of Salamanca.
PROCESS
The study will be carried out in accordance with the provisions of the Medical Oncology
Service of the University Hospital of Salamanca.
Prior authorization by the patient after informed consent read, understood and signed will
proceed to randomization. The subjects will be assigned prospectively, to the study, through
a randomization process, using random numbers generated by computer, to the two conditions of
the study: Control condition: Group I and Experimental condition: Group II.
In the generated table, those individuals that correlate with an odd number will be assigned
to the control condition, while on the contrary, those with even numbers will correspond to
the experimental group.
In the first, the control group will proceed to carry out an exhaustive evaluation at the
time of admission and at the time of discharge, which will consist of: BODE index, which
measures muscle mass index (BMI), dyspnea level by Medical Research Council scale, exercise
capacity by 6-minute walk test and forced expiratory volume during the first second (FEV1);
With all this data the investigators will establish a score in this index. The investigators
will also value activities of daily living (AVD), thanks to the BARTHEL index and Health
Related Quality of Life (HRQOL) thanks to the EuroQol-5D.
Finally, the investigators will take into account a series of intervening variables collected
in a database, previously prepared solely and exclusively for the realization of this
project.
In the second, the experimental group, in addition to performing the same assessment, upon
admission and discharge, as in the control group, will be carried out with each individual
sessions of Integral Respiratory Rehabilitation, by professionals from the disciplines of
nursing and occupational therapy, on a daily basis with an approximate duration of 30-45
minutes.
INTEGRAL RESPIRATORY REHABILITATION PROGRAM
The work methodology used will follow the theoretical basis of Rehabilitation based on
functional integration. It is a new method of intervention in patients in acute and subacute
phase, based fundamentally on "treating dysfunction with function".
It emerged to respond to the continuing demands of patients and caregivers in the geriatric
service, oriented towards the need to achieve greater patient independence. There was a
demotivation of the patients towards the performance of conventional therapeutic treatments
focused on the deficit. For this, it was necessary to create a new intervention method that
would achieve the greatest possible functionality in the shortest period of time (stays in
very mild acute units), seeking much more effective, fast and dynamic treatments.
Functional mobility will be the central axis of the treatment. With this type of
intervention, the reinforcement of the patient's functional gain will be immediate, so that
both he and his family / caregiver will be more involved with the treatment. It can be said
that the level of collaboration increases, ensuring that during the rest of the day, in which
the patient does not receive interventions, the benefits obtained continue to be enhanced
(this is what the investigators call 24-hour therapy), stimulating and mobilizing the patient
outside of the room (wandering around, in a wheelchair ...) taking it to the bathroom,
letting them eat alone ... in short, promoting their independence and preventing the
respiratory patient cycle from being fulfilled, which will lead to loss of functionality
resulting from dyspnea that will secondarily worsen the quality of individual's life
The intervention will be carried out thanks to the "reeducation to the effort" carried out in
the individuals, which will have the following interventions:
- Progressive mobilization.
- Gradation and simplification of activities.
- Teaching energy saving techniques.
- Modification of daily activities.
- Breathing exercises.
- Airway permeabilization techniques.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|