Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer

NCT06477302 | Recruiting

• 1 other identifier: (023/039/ICI)(CEI/045/23)
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

pulmonary rehabilitation; therapeutic adherence; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Contruction of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC)

  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 Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

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

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

Adherence group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (10)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 32096582 BACKGROUND

• Eggen AC, Reyners AKL, Shen G, Bosma I, Jalving M, Leighl NB, Liu G, Richard NM, Mah K, Shultz DB, Edelstein K, Rodin G. Death Anxiety in Patients With Metastatic Non-Small Cell Lung Cancer With and Without Brain Metastases. J Pain Symptom Manage. 2020 Aug;60(2):422-429.e1. doi: 10.1016/j.jpainsymman.2020.02.023. Epub 2020 Mar 5.

  PMID: 32145337 BACKGROUND

• 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.

  PMID: 31016811 BACKGROUND

• Papadopoulos D, Kiagia M, Charpidou A, Gkiozos I, Syrigos K. Psychological correlates of sleep quality in lung cancer patients under chemotherapy: A single-center cross-sectional study. Psychooncology. 2019 Sep;28(9):1879-1886. doi: 10.1002/pon.5167. Epub 2019 Jul 18.

  PMID: 31264308 BACKGROUND

• 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.

  PMID: 29121876 BACKGROUND

• 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.

  PMID: 28063862 BACKGROUND

• 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.

  PMID: 23263699 BACKGROUND

• 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.

  PMID: 8433390 BACKGROUND

• Saad FA, Busque C, Vitiello L, Danieli GA. DXS997 localized to intron 48 of dystrophin. Hum Mol Genet. 1994 Jun;3(6):1034. doi: 10.1093/hmg/3.6.1033. No abstract available.

  PMID: 7951226 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Study Officials

• Oscar G Arrieta, MD

  Instituto Nacional de Cancerologia (INCan) Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar G Arrieta, MD

CONTACT

+52 55 5628 0400; ogar@unam.mx

Josue R Alcantar-Correa, MD

CONTACT

+52 55 5628 0400; richard.alcantar.incan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: June 23, 2023
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

ME (1)