Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)

• Registration Number: NCT06477302
• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

Brief Summary

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.

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 Timeline

• Study Start: 2023-06-23
• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-06-23
• Study Completion: 2026-06-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 281

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adherence group	Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)	Patients with a confirmed diagnosis of lung cancer who are undergoing respiratory rehabilitation treatment with at least one month of monitoring and follow-up.

Primary Outcome Measures

Name	Time	Method
Contruction of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC)	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.

Secondary Outcome Measures

Name	Time	Method
Verify the concurrent validity of the instrument	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).

Trial Locations

Locations (1)

Instituto Nacional de Cancerologia; 🇲🇽 Mexico City, Mexico