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Recruiting NCT06477302

Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer

Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC).
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Mexico · 1 center
  • Instituto Nacional de Cancerologia — Mexico City

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06477302 · (023/039/ICI)(CEI/045/23)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗