NCT05526482

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

March 2, 2022

Last Update Submit

August 31, 2022

Conditions

Keywords

lung cancertele-physiotherapypreoperativethoracic surgery

Outcome Measures

Primary Outcomes (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.

    1-4 weeks

Secondary Outcomes (7)

  • Adherence with treatment time -minutes of treatment

    1-4 weeks

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

    1-4 weeks

  • Dyspnea- mMRC (modified Medical Research Council)

    1-4 weeks

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

    1-4 weeks

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

    1-4 weeks

  • +2 more secondary outcomes

Interventions

preoperative respiratory exercises and thoracic surgery with a mobile application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dolça Gras Pacheco, Msc

    Col·legi de Fisioterapeutes de Catalunya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

September 2, 2022

Study Start

March 2, 2022

Primary Completion

August 23, 2022

Study Completion

August 23, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations