Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer

NCT ID: NCT06477302

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-23

Study Completion Date

2027-06-23

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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pulmonary rehabilitation therapeutic adherence Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type BEHAVIORAL

Patients will be given a measurement instrument to determine the level of therapeutic adherence.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Oscar Gerardo Arrieta Rodríguez

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar G Arrieta, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia (INCan) Mexico

Locations

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Instituto Nacional de Cancerologia

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Oscar G Arrieta, MD

Role: CONTACT

Phone: +52 55 5628 0400

Email: [email protected]

Josue R Alcantar-Correa, MD

Role: CONTACT

Phone: +52 55 5628 0400

Email: [email protected]

Facility Contacts

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Oscar G Arrieta, MD

Role: primary

Josue R Alcantar-Correa, MD

Role: backup

References

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Reference Type BACKGROUND
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McFarland DC, Jutagir DR, Miller A, Nelson C. Physical problem list accompanying the distress thermometer: Its associations with psychological symptoms and survival in patients with metastatic lung cancer. Psychooncology. 2020 May;29(5):910-919. doi: 10.1002/pon.5367. Epub 2020 Mar 11.

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Tan H, Chen S, Ercolano E, Lazenby M, Davies M, Chen J, McCorkle R. The prevalence and related factors associated with psychosocial distress among 420 hospitalised lung cancer patients in China: A case study. Eur J Cancer Care (Engl). 2019 Jul;28(4):e13046. doi: 10.1111/ecc.13046. Epub 2019 Apr 24.

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Ernst J, Mehnert A, Dietz A, Hornemann B, Esser P. Perceived stigmatization and its impact on quality of life - results from a large register-based study including breast, colon, prostate and lung cancer patients. BMC Cancer. 2017 Nov 9;17(1):741. doi: 10.1186/s12885-017-3742-2.

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Vodermaier A, Lucas S, Linden W, Olson R. Anxiety After Diagnosis Predicts Lung Cancer-Specific and Overall Survival in Patients With Stage III Non-Small Cell Lung Cancer: A Population-Based Cohort Study. J Pain Symptom Manage. 2017 Jun;53(6):1057-1065. doi: 10.1016/j.jpainsymman.2016.12.338. Epub 2017 Jan 4.

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Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.

Reference Type BACKGROUND
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Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

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Reference Type BACKGROUND
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Other Identifiers

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(023/039/ICI)(CEI/045/23)

Identifier Type: -

Identifier Source: org_study_id