Occupational TherapyNCT04186754
Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney
A study testing Comprehensive functional care plan and Traditional intervention without rehabilitation in people with Occupational Therapy and Cancer, run by University of Salamanca at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Therapy, Cancer, Dyspnea
- What is being tested?
- Comprehensive functional care plan and Traditional intervention without rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have an anatomopathological diagnosis of cancer disease among the reasons for admission.
- Present at least some level 2 or moderate dyspnea parameters on the MRC scale.
- Be admitted to the University Hospital of Salamanca.
- Sign an informed consent authorizing their voluntary participation in the study.
Who cannot join
- Present a diagnosis of bone metastases.
- Not having an adequate cognitive state to understand and carry out the orders provided.
- Carry out a number of rehabilitation sessions of less than 5.
- Present hemoglobin levels below 10g / dl.
- To be an active smoker today.
- Present pleural effusion.
- Present febrile neutropenia.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Occupational Therapy, Cancer, Dyspnea, Rehabilitation
- Being tested
- Comprehensive functional care plan, Traditional intervention without rehabilitation
- Keywords
- Occupational Therapy, Cancer, Dyspnea
- Medical subject headings
- Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive functional care planProcedure or surgery
The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.
Traditional intervention without rehabilitationProcedure or surgery
Clinical control by nursing professionals and exclusively pharmacological treatment
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive functional care plan | Experimental | The intervention will be carried out thanks to the "reeducation to the effort" carried out in the individuals, which will have the following interventions:
The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy. Receives: Procedure: Comprehensive functional care plan |
| Traditional intervention without rehabilitation | Active comparator | * Nursing care.
* Medical care.
* Spiritual attention. Receives: Procedure: Traditional intervention without rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnoea
MRC scale
Measured: Up to 3 years
Secondary outcomes (1)
Activities of Daily Living
Barthel index
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Sep 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca
- Investigators
- Eduardo IP Fernández, OT, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186754
- Sponsor's protocol ID
- 245380
- Status last verified
- Mar 2020
- First submitted
- 3 Sep 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A specific database will be created to which any external researcher can access after contact by email to the email edujfr@usal.es
Publications
Fernandez-Rodriguez EJ, Sanchez-Gomez C, Fonseca-Sanchez E, Cruz-Hernandez JJ, Rihuete-Galve MI. Impact of a multimodal effort re-education programme on functionality, physical performance, and functional capacity in cancer patients with dyspnoea: a randomised experimental study. Support Care Cancer. 2024 Sep 6;32(10):639. doi: 10.1007/s00520-024-08852-1.
PubMed 39237780
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Randomized Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney
- ClinicalTrials.gov ID
- NCT04186754
- Acronym / sponsor ID
- 245380
- Conditions
- Occupational Therapy, Cancer, Dyspnea, Rehabilitation
- Keywords
- Occupational Therapy, Cancer, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive functional care plan | Experimental | Procedure: Comprehensive functional care planThe intervention will be carried out thanks to the "reeducation to the effort" carried out in the individuals, which will have the following interventions: The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy. |
| Traditional intervention without rehabilitation | Active comparator | Procedure: Traditional intervention without rehabilitation* Nursing care. * Medical care. * Spiritual attention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have an anatomopathological diagnosis of cancer disease among the reasons for admission.
- Present at least some level 2 or moderate dyspnea parameters on the MRC scale.
- Be admitted to the University Hospital of Salamanca.
- Sign an informed consent authorizing their voluntary participation in the study.
Key exclusion criteria (7 listed)
- Present a diagnosis of bone metastases.
- Not having an adequate cognitive state to understand and carry out the orders provided.
- Carry out a number of rehabilitation sessions of less than 5.
- Present hemoglobin levels below 10g / dl.
- To be an active smoker today.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive functional care planThe treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy. | Procedure or surgery | Comprehensive functional care plan |
| Traditional intervention without rehabilitationClinical control by nursing professionals and exclusively pharmacological treatment | Procedure or surgery | Traditional intervention without rehabilitation |
Primary outcome
Dyspnoea
Time frame: Up to 3 years
MRC scale
1 secondary outcome
Activities of Daily Living
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 39237780Fernandez-Rodriguez EJ, Sanchez-Gomez C, Fonseca-Sanchez E, Cruz-Hernandez JJ, Rihuete-Galve MI. Impact of a multimodal effort re-education programme on functionality, physical performance, and functional capacity in cancer patients with dyspnoea: a randomised experimental study. Support Care Cancer. 2024 Sep 6;32(10):639. doi: 10.1007/s00520-024-08852-1.
- Individual participant dataSharing planned: Yes. A specific database will be created to which any external researcher can access after contact by email to the email edujfr@usal.es
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo IP Fernández, OT principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive functional care plan and Traditional intervention without rehabilitation in people with Occupational Therapy and Cancer, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnoea (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.