Illness Expectations in Pulmonary Fibrosis (CAMFP)

Between Beliefs and Expectations in Pulmonary Fibrosis: a Prospective Cohort Study With Mixed Methods.

This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Other: Psychological questionnaires

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
  • Milano, Italy, 20148
    • Don Gnocchi Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary fibrosis, at any stage, of any gender and age

Description

Inclusion Criteria:

• Patients with pulmonary fibrosis
• Patients using oxygen therapy
• Patients using non-invasive ventilation
• Patients undergoing pharmacological treatment
• Patients who speak and understand the Italian language

Exclusion Criteria:

• Patients who do not provide their consent
• Patients without pulmonary fibrosis
• Patients with psychiatric disorders or cognitive impaiment
• Patients who don't speak or understand Italian language

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Pulmonary Fibrosis at the Don Gnocchi Foundation (Milan); 42 patients	Other: Psychological questionnaires; The questionnaires will be completed at the time of enrollment (T0), and at the 6- and 12-month follow-ups.
Patients with Pulmonary Fibrosis at the Policlinico (Milano); 42	Other: Psychological questionnaires; The questionnaires will be completed at the time of enrollment (T0), and at the 6- and 12-month follow-ups.
Patients with Pulmonary Fibrosis at the FIMARP ONLUS; 46	Other: Psychological questionnaires; The questionnaires will be completed at the time of enrollment (T0), and at the 6- and 12-month follow-ups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Oxygen Therapy	Use of oxygen and respective quantities (liters/minute at rest and during exertion).	from October 2023 to October 2025
Adherence to Non invasive ventilation	Use of Non-Invasive Ventilation (nighttime/daytime or both; prescribed and actual hours of usage).	from October 2023 to October 2025
Illness beliefs	Assessed using the Brief Illness Perception Questionnaire (B-IPQ), a nine-question scale designed to rapidly assess cognitive and emotional representations of the illness. Assessed using the Brief Illness Perception Questionnaire (B-IPQ), a nine-question scale designed to rapidly assess cognitive and emotional representations of the illness.	from October 2023 to October 2025
Pharmacological treatment Beliefs	Assessed using the Beliefs about Medicines Questionnaire (BMQ), a tool designed to evaluate individuals' beliefs about medications. It has been validated for use in patients with chronic illnesses and has been shown to predict treatment adherence in other groups, such as individuals with asthma.	from October 2023 to October 2025
Illness Expectations	Specific questions formulated to assess explicit illness expectations in Pulmonary Fibrosis are proposed.	from October 2023 to October 2025
Illness Cognitions	Illness Cognition Questionnaire (ICQ), a questionnaire assessing three ways of cognitively evaluating the stressful and adverse nature of a chronic illness: helplessness, acceptance, and perceived benefits.	from October 2023 to October 2025
Adherence to Pharmacological Treatment	Types of medications taken (Pirfenidone/Nintedanib/Other); assessed as the ratio between the received daily dose (RDD) and the prescribed daily dose (PDD); also evaluated using the Medication Adherence Report Scale (MARS-5), a 5-item questionnaire.	from October 2023 to October 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic variables	Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as family history of respiratory diseases, alcohol use (frequency), physical activity (frequency and type), level of education, marital status, onset of initial symptoms, and date of diagnosis will be considered.	from October 2023 to October 2025
Clinical and medical data	Weight and height (for calculation of Body Mass Index, BMI); comorbidities (diabetes, hypertension, hypercholesterolemia, presence of other conditions), perceived symptoms (e.g., dyspnea, cough, chest pain, fatigue and weakness, muscle and joint pains, weight loss...). Additionally, parameters from respiratory function tests (particularly Forced Vital Capacity (FVC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), arterial blood gas analysis) will be recorded. These data will be extracted from the latest available medical report and therefore from the last pulmonary visit conducted as part of routine clinical practice (please note that medical visits paid for by this project are not included).	from October 2023 to October 2025

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE

Publications and helpful links

General Publications

• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
• Meyer KC. Pulmonary fibrosis, part I: epidemiology, pathogenesis, and diagnosis. Expert Rev Respir Med. 2017 May;11(5):343-359. doi: 10.1080/17476348.2017.1312346. Epub 2017 Apr 10.
• Raghu G, Chen SY, Hou Q, Yeh WS, Collard HR. Incidence and prevalence of idiopathic pulmonary fibrosis in US adults 18-64 years old. Eur Respir J. 2016 Jul;48(1):179-86. doi: 10.1183/13993003.01653-2015. Epub 2016 Apr 28.
• Wolters PJ, Blackwell TS, Eickelberg O, Loyd JE, Kaminski N, Jenkins G, Maher TM, Molina-Molina M, Noble PW, Raghu G, Richeldi L, Schwarz MI, Selman M, Wuyts WA, Schwartz DA. Time for a change: is idiopathic pulmonary fibrosis still idiopathic and only fibrotic? Lancet Respir Med. 2018 Feb;6(2):154-160. doi: 10.1016/S2213-2600(18)30007-9.
• Ley B, Collard HR. Epidemiology of idiopathic pulmonary fibrosis. Clin Epidemiol. 2013 Nov 25;5:483-92. doi: 10.2147/CLEP.S54815.
• Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Jacobs JW, Bijlsma JW. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001 Dec;69(6):1026-36.
• Agarwal P, Lin J, Muellers K, O'Conor R, Wolf M, Federman AD, Wisnivesky JP. A structural equation model of relationships of health literacy, illness and medication beliefs with medication adherence among patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2021 Jun;104(6):1445-1450. doi: 10.1016/j.pec.2020.11.024. Epub 2020 Nov 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): October 10, 2023
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Illness Perceptions; Pulmonary Fibrosis; Adherence to treatment; Clinical Psychology; Rehabilitation Psychology; Illness Expectations
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: FDG_ 88-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No