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Lung CancerNCT05526482

Preoperative Treatment of Respiratory Physiotherapy in Lung Cancer

An observational study of Lung Cancer and Physical Therapy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Physical Therapy, Thoracic Surgery
What is being tested?
mobile app
Type of treatment
Medical device
How many people
8 participants
Where
1 siteSpain
Study dates
2 Mar 2022to 23 Aug 2022
Phase
Observational
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

Study population: The study is aimed at patients diagnosed with pulmonary cancer candidates for surgery with curative intent a the HSCSP.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

Other trials in Spain

About this study

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).

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).

Read the 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

Being tested
mobile app
Keywords
lung cancer, tele-physiotherapy, preoperative, thoracic surgery
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mobile appDevice

    preoperative respiratory exercises and thoracic surgery with a mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    will be assessed over time of treatment. 80% compliance with treatment.

    Measured: 1-4 weeks

Secondary outcomes (7)

  1. Adherence with treatment time -minutes of treatment

    we will collect them with the minutes of treatment that appear in the application

    Measured: 1-4 weeks

  2. The capacity of effort- 6MWT (6 meters walking test)

    the capacity of effort with the 6 minutes walking test Evaluate the capacity of effort before and after the tele-physiotherapy program in patients undergoing thoracic surgery diagnosed with lung cancer

    Measured: 1-4 weeks

  3. Dyspnea- mMRC (modified Medical Research Council)

    Dyspnea in activities of daily living before and after the program with mMRC. 0 Absence of dyspnea on intense exercise

    1 Dyspnea when walking fast on level ground, or when walking up a slight incline. pronounced. two Dyspnea causes you to be unable to keep up with other people in the same age walking on level ground or having to stop to rest when walking on level ground at your own pace. 3 Dyspnea makes you have to stop to rest after walking 100 meters or a few minutes after walking on the flat. 4 Dyspnea prevents the patient from leaving the house or appears with activities such as dressing or undress. tele-physiotherapy performed on patients diagnosed with CP who are candidates for surgery thoracic.

    Measured: 1-4 weeks

  4. Quality of Life Questionnaire module for Lung Cancer patients QLQ-C30

    the evolution of health-related quality of life before and after the program with EORTC QLQ-C30.

    Quality of Life Questionnaire module for Lung Cancer patients QLQ-C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    QLQ-LC 13: All of the scales and single item measures range in score from 0 to 100. A high score for the symptom scales / single items represents a high level of symptomatology or problems.

    Measured: 1-4 weeks

  5. Quality of Life Questionnaire module for Lung Cancer patients QLQ-LC 13

    the evolution of health-related quality of life before and after the program with Quality of Life Questionnaire module for Lung Cancer patientsQLQ-LC 13.

    QLQ-LC 13: All of the scales and single item measures range in score from 0 to 100. A high score for the symptom scales / single items represents a high level of symptomatology or problems.

    Measured: 1-4 weeks

  6. Anxiety and depression

    the evolution of the degree of anxiety and depression before and after of the program.

    Each question is scored from 0-3. There are 14 questions of which 7 assess depression and 7 assess anxiety. Scoring: 0-7 Normal, 8-10 Borderline abnormal (borderline case), 11-21 Abnormal (case).

    Measured: 1-4 weeks

  7. degree of satisfaction- satisfaction questionnaire

    the degree of satisfaction of the program after the program. There are 2 closed questions and a question and a satisfaction rating of 0-10. 0 is the minimum satisfaction and 10 is the maximum satisfaction

    Measured: 1-4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start2 Mar 2022
  3. Primary completion23 Aug 2022
  4. Study completion23 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526482
Sponsor's protocol ID
IIBSP-TFR-2021-126
Status last verified
Aug 2022
First submitted
2 Mar 2022
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Physical Therapy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 1 inclusion and 1 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 2 Sep 2022. 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?

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. (time frame: 1-4 weeks). 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 NCT05526482.

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 Sep 2022.

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