Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)

December 16, 2025 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

Construction and Psychometric Properties of the Therapeutic Adherence Scale for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC).

The goal of this non experimental, transversal instrument study is to Construct and determine the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer in Mexican patients with a lung cancer diagnosis.

The main question it aims to answer is: What is the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer of the patients with this diagnosis that are currently undergoing an assessment or follow up program of Respiratory Rehabilitation?

The Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC) will be psychometrically valid and reliable for the evaluation of therapeutic adherence on patients with lung cancer that are undergoing an assessment or follow up of Respiratory Rehabilitation.Participants will be asked to fill out an Identification card and fill out the fifty-six items presented on the STA-RR-LC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For the recruitment patients with lung cancer diagnosis that arrive at the Respiratory Rehabilitation service will be asked if they are willing to participate and fill out the STA.

It will be explained to them as clearly as possible the objective, procedure, risks and benefits of the study and a copy of the Informed Consent will be provided. Lung cancer patients attending the Pulmonary Rehabilitation service will be approached and a verbal explanation of the study will be given.

Study Type

Observational

Enrollment (Estimated)

281

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oscar G Arrieta, MD
  • Phone Number: 44001 +52 55 5628 0400
  • Email: ogar@unam.mx

Study Contact Backup

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
          • Oscar G Arrieta, MD
          • Phone Number: 44001 +52 55 5628 0400
          • Email: ogar@unam.mx
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient registered in the national cancer center with respiratory rehabilitation follow-up.

Description

Inclusion Criteria:

  • Patients diagnosed with lung cancer (SCLC and NSCLC).
  • Over 18 years of age.
  • Voluntary participation by understanding and accepting the informed consent letter.
  • Patients undergoing Respiratory Rehabilitation treatment with one month assessment and follow-up.
  • Patients in active medical treatment.
  • Any clinical stage.
  • Karnofsky Index ≥ 70.

Exclusion Criteria:

  • Severe hearing or visual problems that prevent them from understanding the instructions and answering the instruments (this will be identified as reported in the clinical record file).
  • Severe psychiatric conditions (schizophrenia or psychotic disorders) and/or addiction to any psychoactive substance (this will be identified as reported in the INCanet file).
  • Attentional or memory problems that prevent them from understanding the instructions and answering the instruments (this will be identified as reported in the INCanet file).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adherence group
Patients with a confirmed diagnosis of lung cancer who are undergoing respiratory rehabilitation treatment with at least one month of monitoring and follow-up.
Behavioral: Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)
Patients will be given a measurement instrument to determine the level of therapeutic adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contruction of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC)
Time Frame: the STA-RR-LC will be applied for one time and as soon as the patient has completed one month attending the Respiratory Rehabilitation Service.
The validity of the construction is carried out with an exploratory factor analysis using the Maximum Likelihood extraction method and the oblique rotation (direct Oblimin). Confiability is determitated using the Alpha of Cronbach coefficient.
the STA-RR-LC will be applied for one time and as soon as the patient has completed one month attending the Respiratory Rehabilitation Service.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify the concurrent validity of the instrument
Time Frame: the STA-RR-LC will be applied one time, as soon as the patient has completed one month attending the Respiratory Rehabilitation Service
It will be verified using the current scores of the European Organisation for Research and Treatment of Cancer, specifically the Module of Lung Cancer (EORTC-QLQ-LC29).
the STA-RR-LC will be applied one time, as soon as the patient has completed one month attending the Respiratory Rehabilitation Service

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar G Arrieta, MD, Instituto Nacional de Cancerologia (INCan) Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

June 23, 2027

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (023/039/ICI)(CEI/045/23)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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