CancerNCT06035263
Effects of a Functional Re-education and Environmental Adaptation Programme in Cancer Patients With Associated Respiratory Pathology
A study testing FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME and Health education programme: in people with Cancer and Dyspnea, run by University of Salamanca at 1 site in Spain.
Trial summary
the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Dyspnea, Functionality
- What is being tested?
- FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME and Health education programme:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have, among the reasons for admission, an anatomopathological diagnosis of newly diagnosed or relapsed oncological disease.
- To be admitted to the Oncology Department of the University Hospital of Salamanca.
- Moderate to severe dependency: Barthel Index score between 20 and 55 points.
- Sign an informed consent form authorising their voluntary participation in the study.
Who cannot join
- Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) of less than 24 points.
- Haemoglobin level of less than 10g/dl.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Eduardo Jose Fernandez Rodriguez
Salamanca, Castille and León, 37002
Eduardo PhD Fernandez, PhD, 923294500, edujfr@usal.es
About this study
Official title: Effects of a Functional Re-education and Environmental Adaptation Programme on Levels of Dependency, Dyspnoea, Functional Capacity, Quality of Life and Caregiver Burden in Cancer Patients With Associated Respiratory Pathology
the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that implements conventional clinical practice, and which the investigators also consider to be an essential intervention in the follow-up of patients with associated respiratory pathology once they are discharged from hospital.
Read the detailed description
In recent years, improvements in oncological treatments, together with a strong commitment to preventive strategies, have led to better early diagnosis and better knowledge of the oncological pathology itself, resulting in an exponential increase in the survival of cancer patients. All of this has led to the increasing importance of the concept of "long survivorship".
Along with this increase in survival and the resulting increase in the number of lines of treatment used, there has been an increase in side effects that negatively impact aspects such as functionality or quality of life in patients. Some of these effects may include tumour asthenia, anxiety or associated respiratory pathology (dyspnoea). In some patients with advanced cancer, dyspnoea may be a clinical sign of end-stage disease. Approximately 41% of palliative care patients have dyspnoea and 46% of these describe it as moderate or severe. Furthermore, this incidence increases significantly in patients with an anatomopathological diagnosis of lung cancer, reaching incidences of more than 73% in various studies.
Most patients perceive this dyspnoea as a limiting factor beyond their control, leading to avoidance behaviours that further increase their inactivity. This inevitably has a negative impact on their functionality and leads to patterns of fear/avoidance of exercise in cancer patients, as seen in patients with chronic pain, chronic fatigue syndrome or fibromyalgia. Patients with respiratory problems adapt to their symptoms by reducing their activity levels. This leads to a deterioration in physical fitness and exertional dyspnoea, known as the "respiratory patient cycle".
For the control of dyspnoea, the investigators believe that the measures used in conventional clinical practice, developed mainly from a pharmacological point of view, can be implemented, but that they are not sufficient to achieve optimal symptomatic control.
Current pharmacological treatment does not always manage to control the main symptom of respiratory pathologies: dyspnoea, perhaps because of its multifactorial nature. Most patients perceive this symptom as a limiting factor beyond their control, leading them to adopt avoidance behaviours that increase their inactivity, with negative consequences for their functionality. Therefore, from the point of view of comprehensive care for the patient, not only for the symptom, the investigators have observed that it is necessary to use other interventions that achieve the patient's readaptation to their daily activity.
the investigators have observed that cancer patients with respiratory pathology adapt to their symptoms by reducing their level of activity. This leads to a deterioration in their physical condition and dyspnoea on exertion. Dyspnoea leads to progressive disability with loss of mobility, self-esteem, work and social relationships.
These data show that associated respiratory pathology is a common problem in oncology, which is still underestimated by professionals. It has been observed that people with this process find it difficult to normalise their daily lives, either because of a deterioration in their clinical condition or because of a problem in generalising what they have learned during their hospital stay.
In terms of intervention, the NCCN panel considers education and energy conservation techniques to be fundamental, always within a complete functional rehabilitation programme.
In addition to educational measures, the NCCN panel recommends the prescription of energy conservation techniques, presenting them as useful in controlling this associated respiratory pathology. To this end, the panel analyses, on the one hand, a multicentre clinical trial involving 296 patients currently under active treatment, in whom a reduction in symptom intensity was reported after application of the programme. On the other hand, they present a meta-analysis including 113 studies with a total sample of 11,525 patients, showing an improvement in individuals after the use of non-pharmacological measures to control associated respiratory pathology (weighted effect size, 0.30; 95% CI, 0.25-0.36; p<0.001).
The common presence of associated respiratory pathology in cancer patients is a factor that can cause changes in body composition, such as loss of muscle mass or an increase in visceral fat. This type of non-pharmacological intervention has been shown to be an important tool in improving symptoms and some parameters related to body composition. In the study by Madison et al, moderate exercise (bioelectrical impedance) over 12 weeks was associated with a reduction in body fat in colorectal cancer survivors. Another study showed that an 8-week exercise intervention increased skeletal muscle mass and decreased visceral fat in a group of head and neck cancer patients undergoing chemotherapy. Fernandez-Lao et al showed that a multimodal exercise programme in breast cancer patients led to a reduction in body fat and an increase in lean body mass in a group of breast cancer patients. However, despite the potential effects, there is little evidence of functional rehabilitation interventions that have assessed the effects on body composition in patients with associated respiratory pathology.
The scientific evidence and recent conclusions of expert meetings on cancer and the benefits of these psychosocial interventions, both in the prevention and treatment of the different clinical aspects of cancer survivors or patients undergoing cancer treatment, point to the existence of sufficient evidence to support their efficacy in addressing physical function, fatigue, quality of life, pain, anxiety and depressive symptoms, among others, related to cancer.
Non-pharmacological psychosocial interventions have therefore been shown to be even more effective than pharmacological interventions in addressing these associated symptoms, leading us to consider the bio-psychosocial approach and multidisciplinary intervention (oncology, nursing, physiotherapy, occupational therapy and medicine) as the global context of intervention. For this reason, aspects related to loss of function and pain associated with anxiety-avoidance disorders should also be assessed and addressed, which can be assessed using kinesiophobia scores.
The cognitive-behavioural model of fear of exercise suggests that patients with chronic pain or fatigue syndrome tend to avoid activity because they believe that activity is the cause of these symptoms, such as pain and fatigue. Avoidance behaviour leads to even greater fear and symptoms, resulting in more pain or fatigue, which may extend to patients with associated respiratory pathology, so it is important to restore optimal activity levels and avoid loss of physical function and ability.
The choice of the most appropriate intervention setting is based on clinical complexity and the patient's ability to self-manage their situation. For this reason, and with the support of experts, our study proposes a supervised intervention in the home setting after hospital discharge, adapted to the specific situation of patients with associated respiratory pathology who have just been discharged from hospital. This is in line with recommendations to improve and increase access and adherence to a functional rehabilitation programme for these patients.
Supervised follow-up outside the healthcare setting, both in the community and at home, has been shown to be successful in previous trials. This is shown in a meta-analysis of 14 randomised controlled clinical trials in breast cancer survivors with supervised intervention by telephone or e-mail. In any case, despite the choice of the home setting for its feasibility in our study population, supervision and controlled follow-up of the intervention is still a guarantee of good results, as shown in another recent meta-analysis of 128 trials with a total of 13,050 cancer patients, where supervised programmes had greater effects on physical activity. Follow-up is important not only for the correct implementation of the intervention programme, but also for achieving high adherence to the programme, as shown in a review of 23 trials and 1372 patients.
The best results in patients surviving or undergoing cancer treatment have been obtained with multimodal exercise programmes that combine different types of exercise, mainly aerobic and strength training, in addition to other interventions such as reeducation in activities of daily living and health education, adapted to the patient's general condition and functional capacity.
For this reason, the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that implements conventional clinical practice, and which the investigators also consider to be an essential intervention in the follow-up of patients with associated respiratory pathology once they are discharged from hospital.
- Conditions
- Cancer, Dyspnea, Functionality, Quality of Life, Functional Capacity
- Being tested
- FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME, Health education programme:
- Keywords
- Functional Status, Cancer, Dyspnea, Quality of Life, Occupational therapy
- Medical subject headings
- Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMMEOther
the prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.
Health education programme:Other
instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle.
They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME | Experimental | prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge. Receives: Other: FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME |
| Health education programme: | Active comparator | instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle.
They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group. Receives: Other: Health education programme: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of daily living
Barthel Index
Measured: Baseline; 1 week (follow up); 2 weeks (final)
Secondary outcomes (5)
dyspnoea
Medical Research Council Dyspnoea: Scores: (0, best - 4, worst)
Measured: Baseline; 1 week (follow up); 2 weeks (final)
Health-related quality of life
EuroQol 5-D questionnaire. Scores: ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health).
Measured: Baseline; 1 week (follow up); 2 weeks (final)
General Pain
Visual Analogue Scale. Scores: ranging from 0 (lowest degree of pain) to 10 (highest degree of pain).
Measured: Baseline; 1 week (follow up); 2 weeks (final)
Physical performance assessment
Short Physical Performance Battery. The total SPPB score is the sum of the three sub-tests and ranges from 0 (worst) to 12. Changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Measured: Baseline; 1 week (follow up); 2 weeks (final)
pain/fatigue-related fear of movement
Tampa Scale for Kinesiophobia. The results are obtained by means of a total raw score (which can range from 17 to 68) and two subscale scores.
Measured: Baseline; 1 week (follow up); 2 weeks (final)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035263
- Sponsor's protocol ID
- University of Salamanca 2
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandez-Rodriguez EJ, Sanchez-Gomez C, Fonseca-Sanchez E, Rihuete-Galve MI, Hernandez JJC. Impact of a Functional Intervention with Home Follow-Up on Respiratory Symptoms and Functionality in Oncology Patients: A Randomised Clinical Trial. Support Care Cancer. 2026 Apr 29;34(5):477. doi: 10.1007/s00520-026-10725-8.
PubMed 42056330Fernandez-Rodriguez EJ, Rihuete-Galve MI, Garcia-Martin A, Sanchez-Gomez C, Barbero-Iglesias FJ, Mendez-Sanchez R, Puente-Gonzalez AS, Saez-Gutierrez S, Fonseca-Sanchez E, Cruz-Hernandez JJ. Impact of functional re-education and environmental adaptation in cancer patients with respiratory pathology: Study protocol. PLoS One. 2025 Jan 9;20(1):e0313207. doi: 10.1371/journal.pone.0313207. eCollection 2025.
PubMed 39787149
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Functional Re-education and Environmental Adaptation Programme on Levels of Dependency, Dyspnoea, Functional Capacity, Quality of Life and Caregiver Burden in Cancer Patients With Associated Respiratory Pathology
- ClinicalTrials.gov ID
- NCT06035263
- Acronym / sponsor ID
- University of Salamanca 2
- Conditions
- Cancer, Dyspnea, Functionality, Quality of Life, Functional Capacity
- Keywords
- Functional Status, Cancer, Dyspnea, Quality of Life, Occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Sep 2023 (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.
the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that implements conventional clinical practice, and which the investigators also consider to be an essential intervention in the follow-up of patients with associated respiratory pathology once they are discharged from hospital.
Detailed description
In recent years, improvements in oncological treatments, together with a strong commitment to preventive strategies, have led to better early diagnosis and better knowledge of the oncological pathology itself, resulting in an exponential increase in the survival of cancer patients. All of this has led to the increasing importance of the concept of "long survivorship".
Along with this increase in survival and the resulting increase in the number of lines of treatment used, there has been an increase in side effects that negatively impact aspects such as functionality or quality of life in patients. Some of these effects may include tumour asthenia, anxiety or associated respiratory pathology (dyspnoea). In some patients with advanced cancer, dyspnoea may be a clinical sign of end-stage disease. Approximately 41% of palliative care patients have dyspnoea and 46% of these describe it as moderate or severe. Furthermore, this incidence increases significantly in patients with an anatomopathological diagnosis of lung cancer, reaching incidences of more than 73% in various studies.
Most patients perceive this dyspnoea as a limiting factor beyond their control, leading to avoidance behaviours that further increase their inactivity. This inevitably has a negative impact on their functionality and leads to patterns of fear/avoidance of exercise in cancer patients, as seen in patients with chronic pain, chronic fatigue syndrome or fibromyalgia. Patients with respiratory problems adapt to their symptoms by reducing their activity levels. This leads to a deterioration in physical fitness and exertional dyspnoea, known as the "respiratory patient cycle".
For the control of dyspnoea, the investigators believe that the measures used in conventional clinical practice, developed mainly from a pharmacological point of view, can be implemented, but that they are not sufficient to achieve optimal symptomatic control.
Current pharmacological treatment does not always manage to control the main symptom of respiratory pathologies: dyspnoea, perhaps because of its multifactorial nature. Most patients perceive this symptom as a limiting factor beyond their control, leading them to adopt avoidance behaviours that increase their inactivity, with negative consequences for their functionality. Therefore, from the point of view of comprehensive care for the patient, not only for the symptom, the investigators have observed that it is necessary to use other interventions that achieve the patient's readaptation to their daily activity.
the investigators have observed that cancer patients with respiratory pathology adapt to their symptoms by reducing their level of activity. This leads to a deterioration in their physical condition and dyspnoea on exertion. Dyspnoea leads to progressive disability with loss of mobility, self-esteem, work and social relationships.
These data show that associated respiratory pathology is a common problem in oncology, which is still underestimated by professionals. It has been observed that people with this process find it difficult to normalise their daily lives, either because of a deterioration in their clinical condition or because of a problem in generalising what they have learned during their hospital stay.
In terms of intervention, the NCCN panel considers education and energy conservation techniques to be fundamental, always within a complete functional rehabilitation programme.
In addition to educational measures, the NCCN panel recommends the prescription of energy conservation techniques, presenting them as useful in controlling this associated respiratory pathology. To this end, the panel analyses, on the one hand, a multicentre clinical trial involving 296 patients currently under active treatment, in whom a reduction in symptom intensity was reported after application of the programme. On the other hand, they present a meta-analysis including 113 studies with a total sample of 11,525 patients, showing an improvement in individuals after the use of non-pharmacological measures to control associated respiratory pathology (weighted effect size, 0.30; 95% CI, 0.25-0.36; p<0.001).
The common presence of associated respiratory pathology in cancer patients is a factor that can cause changes in body composition, such as loss of muscle mass or an increase in visceral fat. This type of non-pharmacological intervention has been shown to be an important tool in improving symptoms and some parameters related to body composition. In the study by Madison et al, moderate exercise (bioelectrical impedance) over 12 weeks was associated with a reduction in body fat in colorectal cancer survivors. Another study showed that an 8-week exercise intervention increased skeletal muscle mass and decreased visceral fat in a group of head and neck cancer patients undergoing chemotherapy. Fernandez-Lao et al showed that a multimodal exercise programme in breast cancer patients led to a reduction in body fat and an increase in lean body mass in a group of breast cancer patients. However, despite the potential effects, there is little evidence of functional rehabilitation interventions that have assessed the effects on body composition in patients with associated respiratory pathology.
The scientific evidence and recent conclusions of expert meetings on cancer and the benefits of these psychosocial interventions, both in the prevention and treatment of the different clinical aspects of cancer survivors or patients undergoing cancer treatment, point to the existence of sufficient evidence to support their efficacy in addressing physical function, fatigue, quality of life, pain, anxiety and depressive symptoms, among others, related to cancer.
Non-pharmacological psychosocial interventions have therefore been shown to be even more effective than pharmacological interventions in addressing these associated symptoms, leading us to consider the bio-psychosocial approach and multidisciplinary intervention (oncology, nursing, physiotherapy, occupational therapy and medicine) as the global context of intervention. For this reason, aspects related to loss of function and pain associated with anxiety-avoidance disorders should also be assessed and addressed, which can be assessed using kinesiophobia scores.
The cognitive-behavioural model of fear of exercise suggests that patients with chronic pain or fatigue syndrome tend to avoid activity because they believe that activity is the cause of these symptoms, such as pain and fatigue. Avoidance behaviour leads to even greater fear and symptoms, resulting in more pain or fatigue, which may extend to patients with associated respiratory pathology, so it is important to restore optimal activity levels and avoid loss of physical function and ability.
The choice of the most appropriate intervention setting is based on clinical complexity and the patient's ability to self-manage their situation. For this reason, and with the support of experts, our study proposes a supervised intervention in the home setting after hospital discharge, adapted to the specific situation of patients with associated respiratory pathology who have just been discharged from hospital. This is in line with recommendations to improve and increase access and adherence to a functional rehabilitation programme for these patients.
Supervised follow-up outside the healthcare setting, both in the community and at home, has been shown to be successful in previous trials. This is shown in a meta-analysis of 14 randomised controlled clinical trials in breast cancer survivors with supervised intervention by telephone or e-mail. In any case, despite the choice of the home setting for its feasibility in our study population, supervision and controlled follow-up of the intervention is still a guarantee of good results, as shown in another recent meta-analysis of 128 trials with a total of 13,050 cancer patients, where supervised programmes had greater effects on physical activity. Follow-up is important not only for the correct implementation of the intervention programme, but also for achieving high adherence to the programme, as shown in a review of 23 trials and 1372 patients.
The best results in patients surviving or undergoing cancer treatment have been obtained with multimodal exercise programmes that combine different types of exercise, mainly aerobic and strength training, in addition to other interventions such as reeducation in activities of daily living and health education, adapted to the patient's general condition and functional capacity.
For this reason, the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that implements conventional clinical practice, and which the investigators also consider to be an essential intervention in the follow-up of patients with associated respiratory pathology once they are discharged from hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME | Experimental | Other: FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMMEprescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge. |
| Health education programme: | Active comparator | Other: Health education programme:instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle. They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To have, among the reasons for admission, an anatomopathological diagnosis of newly diagnosed or relapsed oncological disease.
- To be admitted to the Oncology Department of the University Hospital of Salamanca.
- Moderate to severe dependency: Barthel Index score between 20 and 55 points.
- Sign an informed consent form authorising their voluntary participation in the study.
Key exclusion criteria (2 listed)
- Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) of less than 24 points.
- Haemoglobin level of less than 10g/dl.
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 |
|---|---|---|
| FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMMEthe prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge. | Other | FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME |
| Health education programme:instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle. They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group. | Other | Health education programme: |
Primary outcome
Activities of daily living
Time frame: Baseline; 1 week (follow up); 2 weeks (final)
Barthel Index
5 secondary outcomes
dyspnoea
Time frame: Baseline; 1 week (follow up); 2 weeks (final)
Health-related quality of life
Time frame: Baseline; 1 week (follow up); 2 weeks (final)
General Pain
Time frame: Baseline; 1 week (follow up); 2 weeks (final)
Physical performance assessment
Time frame: Baseline; 1 week (follow up); 2 weeks (final)
pain/fatigue-related fear of movement
Time frame: Baseline; 1 week (follow up); 2 weeks (final)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Derived from this study: PubMed 42056330Fernandez-Rodriguez EJ, Sanchez-Gomez C, Fonseca-Sanchez E, Rihuete-Galve MI, Hernandez JJC. Impact of a Functional Intervention with Home Follow-Up on Respiratory Symptoms and Functionality in Oncology Patients: A Randomised Clinical Trial. Support Care Cancer. 2026 Apr 29;34(5):477. doi: 10.1007/s00520-026-10725-8.
- Derived from this study: PubMed 39787149Fernandez-Rodriguez EJ, Rihuete-Galve MI, Garcia-Martin A, Sanchez-Gomez C, Barbero-Iglesias FJ, Mendez-Sanchez R, Puente-Gonzalez AS, Saez-Gutierrez S, Fonseca-Sanchez E, Cruz-Hernandez JJ. Impact of functional re-education and environmental adaptation in cancer patients with respiratory pathology: Study protocol. PLoS One. 2025 Jan 9;20(1):e0313207. doi: 10.1371/journal.pone.0313207. eCollection 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME and Health education programme: in people with Cancer and Dyspnea, 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 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of daily living (time frame: Baseline; 1 week (follow up); 2 weeks (final)). 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 NCT06035263, which also lists 2 linked publications.
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 2 Nov 2023.