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

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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

Tracking Information
First Submitted Date March 16, 2024
First Posted Date March 22, 2024
Last Update Posted Date March 22, 2024
Actual Study Start Date April 19, 2023
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2024)
  • Prevalence of experience of unpleasant sensations or pain [ Time Frame: At enrollment ]
    Prevalence of reported experience of unpleasant sensations orn pain during study procedures
  • Study procedure that causes unpleasant sensations or pain [ Time Frame: At enrollment ]
    Qualitative description of study procedure that causes unpleasant sensations or pain
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 16, 2024)
  • HADS score [ Time Frame: At enrollment ]
    Score on Hospital Anxiety and Depression Scale (HADS) scale
  • ALSFRS score [ Time Frame: At enrollment ]
    Score on Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perception of Unpleasant Sensations During Study Procedures in ALS Patients
Official Title Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Amyotrophic Lateral Sclerosis
Intervention Other: Interview
Interview with ALS patient in which the experiences of unpleasant sensations or pain during study procedures are assessed in a qualitative manner.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 16, 2024)		 20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Martina Sodano +3902619111 ext 2937 m.sodano@auxologico.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT06325865
Other Study ID Numbers 23C305
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Istituto Auxologico Italiano
Original Responsible Party Same as current
Current Study Sponsor Istituto Auxologico Italiano
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Auxologico Italiano
Verification Date March 2024