Digital Voice Analysis as a Measure of Frailty and Distress

NCT ID: NCT05783401

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-19
• Study Completion Date: 2025-11-30

Brief Summary

This study evaluates if it is possible to identify quantitative parameters from audio signals to describe the changes in patient's state in relation to frailty and distress.

Detailed Description

Frailty is a common clinical syndrome especially in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality. The early detection of frailty is of importance in many patient populations to predict treatment outcomes, identify patient needs and coordinate efficient and meaningful care. An electronic assessment of the degree of distress in patients, who are unable to report, would be important to be able to routinely and objectively identify suffering in these patients. Digital voice analysis (DVA) gathers speech samples from individuals via different kinds of recording devices (smartphone, tablet, etc.) and examines a large variety of specific acoustic parameters such as for example frequency and voice quality features. This study is to analyse the potential to evaluate distress and frailty through digital voice analysis. On the contrary to the existing studies, it is intended to record audio and clinical evaluation data from the same subject multiple times during several weeks to be able to analyse temporal changes. This will allow to not only perform inter-subject but as well intra-subject comparisons of changes in audio features with changes of the patient's wellbeing over time. To make the patient speak as freely and relaxed as possible, the patient will describe different images. Different features will be extracted from the audios and potential candidates for a larger patient study will be identified, if data quantity permits using machine learning algorithms. Therefore this study evaluates if it is feasible to gather digital voice samples for voice analyses from cancer patients alongside conventional assessments for frailty (G8 questionnaire and distress (Distress Thermometer) to conduct first, preliminary analyses for identification of potential correlates between voice features and frailty or distress and between changes over time.

Conditions

Frailty; Distress, Emotional

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A: palliative care center

Patients from a palliative care center (Palliativzentrum Hildegard, Basel)

Data acquisition: Speech acquisition

Intervention Type: OTHER

Speech test with synchronized audio and video recording. The speaking exercises and the audio and video recording will be done using a tablet computer and an application developed in-house. Freely available images showing different scenes will be integrated and displayed on the tablet to be described by the patient. The goal is to have at least two and maximum four of them described with several sentences by each patient per session. Parameters will be extracted from the patient's audio data to estimate the changes in distress and frailty.

Data acquisition: G8 Screening tool

Intervention Type: DIAGNOSTIC_TEST

The G8 screening tool consists of seven items dealing with food intake, weight loss, mobility, neuropsychological problem, body mass index, prescription drug, and self-perception of health, from the Mini-Nutritional Assessment (MNA) questionnaire and was developed specifically for elderly cancer patients. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.

Data acquisition: Distress Thermometer

Intervention Type: DIAGNOSTIC_TEST

The distress thermometer (DT) is a measure of psychological distress in cancer patients. The instrument is a self-reported tool using a 0-to-10 rating scale.

Cohort B: mid-size cancer center

Patients from a mid-size cancer center (Tumorzentrum Baselland)

Data acquisition: Speech acquisition

Intervention Type: OTHER

Speech test with synchronized audio and video recording. The speaking exercises and the audio and video recording will be done using a tablet computer and an application developed in-house. Freely available images showing different scenes will be integrated and displayed on the tablet to be described by the patient. The goal is to have at least two and maximum four of them described with several sentences by each patient per session. Parameters will be extracted from the patient's audio data to estimate the changes in distress and frailty.

Data acquisition: G8 Screening tool

Intervention Type: DIAGNOSTIC_TEST

The G8 screening tool consists of seven items dealing with food intake, weight loss, mobility, neuropsychological problem, body mass index, prescription drug, and self-perception of health, from the Mini-Nutritional Assessment (MNA) questionnaire and was developed specifically for elderly cancer patients. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.

Data acquisition: Distress Thermometer

Intervention Type: DIAGNOSTIC_TEST

The distress thermometer (DT) is a measure of psychological distress in cancer patients. The instrument is a self-reported tool using a 0-to-10 rating scale.

Interventions

Data acquisition: Speech acquisition

Speech test with synchronized audio and video recording. The speaking exercises and the audio and video recording will be done using a tablet computer and an application developed in-house. Freely available images showing different scenes will be integrated and displayed on the tablet to be described by the patient. The goal is to have at least two and maximum four of them described with several sentences by each patient per session. Parameters will be extracted from the patient's audio data to estimate the changes in distress and frailty.

Intervention Type: OTHER

Data acquisition: G8 Screening tool

The G8 screening tool consists of seven items dealing with food intake, weight loss, mobility, neuropsychological problem, body mass index, prescription drug, and self-perception of health, from the Mini-Nutritional Assessment (MNA) questionnaire and was developed specifically for elderly cancer patients. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.

Intervention Type: DIAGNOSTIC_TEST

Data acquisition: Distress Thermometer

The distress thermometer (DT) is a measure of psychological distress in cancer patients. The instrument is a self-reported tool using a 0-to-10 rating scale.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Active cancer or haemato-oncological malignancy
• Adults (≥ 18 years)
• Ability to understand, speak and read German language fluently
• Ability to provide written consent
• Sufficient or corrected vision to see the images
• Sufficient auditory comprehension for participation in the study based on the therapist's clinical opinion
• Ability to concentrate for 20-30 minutes based on the investigator's clinical opinion
• Signed informed consent to the study

Exclusion Criteria

• Aphonia, dysphonia or other obvious voice alterations of patient's voice
• Life-expectancy shorter ≤ 14 days as judged by a physician or nurse via "surprise question"
• Breathlessness whilst speaking
• Cognitive impairment as judged by physician or Mini-Cog in the G8 screening tool
• Severe physical, emotional or existential suffering because of which the enrollment and participation in the study would result in patient burden, as judged by the treating physicians and their multiprofessional team members

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Vetter, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Baselland, Klinik für Onkologie, Hämatologie und Immuntherapie

Locations

Palliativzentrum Hildegard, Basel

Basel, , Switzerland

Site Status: RECRUITING

Kantonsspital Baselland, Klinik für Onkologie, Hämatologie und Immuntherapie

Liestal, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Marcus Vetter, PD Dr. med.

Role: CONTACT

marcus.vetter@ksbl.ch

+41 61 925 2525

Jan Gärtner, Prof. Dr. med.

Role: CONTACT

jan.gaertner@pzhi.ch

+41 61 319 7575

Facility Contacts

Jan Gärtner, Prof. Dr. med.

Role: primary

jan.gaertner@pzhi.ch

+41 61 319 7575

Marcus Vetter, PD Dr. med.

Role: primary

marcus.vetter@ksbl.ch

+ 41 61 925 2525

Other Identifiers

2022-01461; th23Vetter

Identifier Type: -

Identifier Source: org_study_id