Clinical trial NCT05526482: Preoperative Treatment of Respiratory Physiotherapy in Lung Cancer
Official title: Applicability of Respiratory Tele-physiotherapy in the Preoperative Context of Thoracic Surgery at the Hospital de la Santa Creu y Sant Pau (HSCSP).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Physical Therapy
Thoracic Surgery
Preoperative
Keywords: lung cancer
tele-physiotherapy
preoperative
thoracic surgery
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is aimed at patients diagnosed with pulmonary cancer candidates for surgery with curative intent a the HSCSP.

Brief summary: The home confinement caused by the COVID-19 pandemic has aroused the need to use telematic communication systems to provide remote treatments. More and more research is being done on preoperative respiratory physiotherapy in patients undergoing thoracic surgery with lung cancer. It is a treatment that has great relevance in the prevention of postoperative complications and in the quality of life of the patient. Therefore, this study is proposed to highlight the applicability of a telematic system of preoperative physiotherapy treatment with the FISSIOS application at the Hospital de la Santa Creu i Sant Pau (HSCSP).

Detailed description: A pilot cohort follow-up study is proposed based on the viability of a tele-physiotherapy program preoperative respiratory thoracic surgery for pulmonary cancer. The Patient selection will be done over a period of 2 months between January and February 2022, without participant limit during this period. The patient will have two face-to-face visits where the assessments and data will be collected. During follow-up patients will do 3-4 video conferencing with the principal investigator. For 3-4 weeks the patients will use the FISSIOS App to follow up of the exercises every day. The study will be conducted at the HSCSP in Barcelona. The results will be analyzed by the Epidemiology of the Hospital de Sant Pau

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-\> 80 years. Candidates for CP resection with curative intent, either for VATS or thoracotomy, which meet the ppo-DLCO\> 35% and ppo-FEV1\> 35% surgical criteria, who agree to participate and sign the informed consent

Exclusion Criteria:

* Patients undergoing tumor resection for cancer requiring pneumonectomy, with cognitive impairment, which are outside the area of influence of the HSCSP or which do not have from an Android / iPhone Operating System (iOS) device. It is also considered an exclusion criterion not fulfilling 50% of the predefined time of the program (a week and a half) and surgical.

Primary outcomes:
measure: Feability to implement a respiratory tele-physiotherapy program in patients diagnosed with Cancer Pulmonary candidates for thoracotomy or VATS at the Hospital de la Santa Creu i Sant Pau.
timeFrame: 1-4 weeks
Secondary outcomes:
measure: Adherence with treatment time -minutes of treatment
timeFrame: 1-4 weeks
measure: The capacity of effort- 6MWT (6 meters walking test)
timeFrame: 1-4 weeks
measure: Dyspnea- mMRC (modified Medical Research Council)
timeFrame: 1-4 weeks
measure: Quality of Life Questionnaire module for Lung Cancer patients QLQ-C30
timeFrame: 1-4 weeks
measure: Quality of Life Questionnaire module for Lung Cancer patients QLQ-LC 13
timeFrame: 1-4 weeks
measure: Anxiety and depression
timeFrame: 1-4 weeks
measure: degree of satisfaction- satisfaction questionnaire
timeFrame: 1-4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Col·legi de Fisioterapeutes de Catalunya
name: Dolça Gras Pacheco, Msc
role: PRINCIPAL_INVESTIGATOR
References: