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Perception of Unpleasant Sensations During Study Procedures in ALS Patients (PESALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06325865
Recruitment Status : Recruiting
First Posted : March 22, 2024
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Study Description
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Brief Summary:

Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.

Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.

This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Interview

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials
Actual Study Start Date : April 19, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Interview
    Interview with ALS patient in which the experiences of unpleasant sensations or pain during study procedures are assessed in a qualitative manner.

Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of experience of unpleasant sensations or pain [ Time Frame: At enrollment ]
    Prevalence of reported experience of unpleasant sensations orn pain during study procedures

  2. Study procedure that causes unpleasant sensations or pain [ Time Frame: At enrollment ]
    Qualitative description of study procedure that causes unpleasant sensations or pain

  3. Duration of unpleasant sensations or pain caused by the study procedure [ Time Frame: At enrollment ]
    Duration in minutes of unpleasant sensations or pain caused by the study procedure


Secondary Outcome Measures :
  1. HADS score [ Time Frame: At enrollment ]
    Score on Hospital Anxiety and Depression Scale (HADS) scale

  2. ALSFRS score [ Time Frame: At enrollment ]
    Score on Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Amyotrophic Lateral Sclerosis (ALS) patients who are currently participating in interventional clinical studies or who have particpated in the recent past.
Criteria

Inclusion Criteria:

  • Spinal or bulbar Amyotrophic Lateral Sclerosis (ALS)
  • Age > 18 years
  • Adequate understanding of Italian language
  • Full understanding of the study
  • Informed consent signed
  • Current or past participation in interventional clinical studies
  • Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score of item # 4 ≥ 2, or score of item #1 ≥ 1

Exclusion Criteria:

  • Clinically relevant cognitive dysfunction
  • Inability to answer orally or by writing to the questions of the interview
  • Hospital Anxiety and Depression Scale (HADS) scale ≥ 11
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06325865


Contacts
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Contact: Martina Sodano +3902619111 ext 2937 m.sodano@auxologico.it

Locations
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Italy
Istituto Auxologico italiano IRCSS, San Luca Hospital Recruiting
Milano, Italy, 20145
Contact: Martina Sodano    +39-02619111 ext 2937    m.sodano@auxologico.it   
Sponsors and Collaborators
Istituto Auxologico Italiano
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT06325865    
Other Study ID Numbers: 23C305
First Posted: March 22, 2024    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Auxologico Italiano:
Study procedures
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases