Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06035263 |
| Other study ID # |
University of Salamanca 2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of Salamanca |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
