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Lung CancerNCT04052100

Multimodal Prehabilitation in Thoracic Surgery

A study testing Multimodal prehabilitation in people with Lung Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Cancer
What is being tested?
Multimodal prehabilitation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteSpain
Study dates
1 Oct 2019to 30 Jun 2021
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Forced espiratory volume in the first second (FEV1) and/or estimated postoperative lung diffusion capacity for carbon monoxide < 60%; and/or,
  • American Society of Anesthesiologist (ASA) index 3-4; and/or,
  • Peak oxygen uptake among 10-20 mL/kg/min.

Who cannot join

  • Non-elective surgery;
  • Metastasic disease;
  • Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.

Trial locations and contacts

1 site in 1 country.

Maria Sanchez contact

+34 932775540

masanchezm@clinic.cat

Spain1 site, 1 recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalonia, 08036

    Anael Barberan-Garcia, PhD, +34 932775540, anaelbg@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial

This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.

Read the detailed description

This trial aims to assess the cost-effectiveness of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery. Secondary objectives are to evaluate the impact of the intervention on: i) Healthcare resuorces use; ii) clinical outcomes; and, iii) patient's and professionals experience with the program.

The program includes X main interventions: i) A motivational interview; ii) A high-intensity exercise training program; iii) A plan for physical activity incentivation; iv) A nutritional optimization program; v) A psicologichal support program; and, vi) A smoking cessation program.

Conditions
Lung Cancer
Being tested
Usual care, Multimodal prehabilitation
Keywords
Prehabilitation, Exercise training, Physical activity, Nutrition, Cognitive behavioural therapy, Smoking cessation
Medical subject headings
Lung Neoplasms, Motor Activity, Smoking Cessation

What participants receive

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

  • Usual careOther

    The standard preoperative measures will consist of a recommendation for physical activity and advice on tobacco smoking cessation and reduction of alcohol intake. In addition, patients who suffer from iron deficient anemia will receive intravenous iron and those at risk of malnutrition (Malnutrition Universal Screening Tool ≥2 (www.bapen.org.uk/pdfs/must/must_full.pdf)) or that require weight control for obesity (IMC≥30) will perform a nutrition intervention by a nutritionist.

  • Multimodal prehabilitationOther

    Also called Prehabilitation

    The experimental group will also carry out a prehabilitation program consisting in:

    1. A motivational interview to reinforce the patient's motivation and generate a commitment in relation to the objectives of the program.
    2. A physical activity promotion program to increase the number of daily steps of patients, measured by a wristband and a mobile App.
    3. A supervised high-intensity exercise training program. D. An individualized nutritional optimization plan with dietary advice and protein supplementation (if necessary). Educational material and motivational messages will be sent through a mobile App.
    4. Psychological support through weekly Mindfulness sessions (1.5 hours duration). Educational material and motivational messages will be sent through a mobile App.
    5. A smoking cessation program consisting psycho-cognitive therapy combined with pharmacological treatment. Educational material and motivational messages will be sent through a mobile App.
Study groups in NCT04052100
Study groupRoleWhat they receive
Usual careActive comparatorPatients following the standard preoperative policies of opur institution
Receives: Other: Usual care
PrehabilitationExperimentalPatients following the standard preoperative policies of opur institution and the multimodal prehabilitation program
Receives: Other: Multimodal prehabilitation

What is being measured

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

  1. Hospital length of stay

    Hospital days of stay

    Measured: During initial hospitalization

Secondary outcomes (20)

  1. Postoperative complications

    Number and severity of postoperative complications

    Measured: During initial hospitalization

  2. 30-day hospital readmissions

    Hospital readmissions during the first 30 days after surgery

    Measured: To 30 days after surgery

  3. 30-day emergency room visits

    Emergency room visits during the first 30 days after surgery

    Measured: To 30 days after surgery

  4. Physical activity

    Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0-126 points (the higher, the better))

    Measured: Baseline and pre-surgery

  5. Aerobic capacity

    Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer

    Measured: Baseline and pre-surgery

  6. Self-perceived physical status

    Physical status measured by the physical domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))

    Measured: Baseline and pre-surgery

  7. Self-perceived mental status

    Mental status measured by the mental domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))

    Measured: Baseline and pre-surgery

  8. Psychological status

    Anxiety and depression levels measured by the Hospital Anxiety and Depression (HAD) questionnaire (range 0-42 points (the lower, the better))

    Measured: Baseline and pre-surgery

  9. Fat free mass index

    Fat free mass index measured by bioimpedance

    Measured: Baseline and pre-surgery

  10. PCR

    Blood levels of PCR

    Measured: Baseline and pre-surgery

  11. ultrasensible PCR

    Blood levels of ultrasensible PCR

    Measured: Baseline and pre-surgery

  12. TNF-α

    Blood levels of TNF-α

    Measured: Baseline and pre-surgery

  13. IL-6

    Blood levels of IL-6

    Measured: Baseline and pre-surgery

  14. IL-8

    Blood levels of IL-8

    Measured: Baseline and pre-surgery

  15. IL-10

    Blood levels of IL-10

    Measured: Baseline and pre-surgery

  16. 8-isoprostane

    Blood levels of 8-isoprostane

    Measured: Baseline and pre-surgery

  17. fibrinogen

    Blood levels of fibrinogen

    Measured: Baseline and pre-surgery

  18. leptin

    Blood levels of leptin

    Measured: Baseline and pre-surgery

  19. adiponectin

    Blood levels of adiponectin

    Measured: Baseline and pre-surgery

  20. white cells

    Blood levels of white cells

    Measured: Baseline and pre-surgery

Timeline

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

  1. First posted9 Aug 2019
  2. Study start1 Oct 2019
  3. Primary completion31 May 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04052100
Sponsor's protocol ID
HCB/2018/1138
Status last verified
Dec 2019
First submitted
5 Apr 2019
Last updated
11 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barberan-Garcia A, Navarro-Ripoll R, Sanchez-Lorente D, Moises-Lafuente J, Boada M, Messaggi-Sartor M, Gonzalez-Vallespi L, Montane-Muntane M, Alsina-Restoy X, Campero B, Lopez-Baamonde M, Romano-Andrioni B, Guzman R, Lopez A, Arguis MJ, Roca J, Martinez-Palli G. Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol. BMC Health Serv Res. 2020 Mar 12;20(1):207. doi: 10.1186/s12913-020-05078-9.

    PubMed 32164687

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal prehabilitation in people with Lung Cancer, run by Hospital Clinic of Barcelona 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 3 inclusion and 3 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 11 Dec 2019. 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?

Contact Maria Sanchez (+34 932775540, masanchezm@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital length of stay (time frame: During initial hospitalization). 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 NCT04052100, which also lists 1 linked publication.

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 11 Dec 2019.

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Multimodal Prehabilitation in Thoracic Surgery | AzTrials