Distress and Emotional monitoring Z51
Conditions
Interventions
Group 1: Observations group (only 1 Arm): Patients included have been diagnosed with localized breast cancer and are attending to radiotherapy treatment.
Sponsors
Intelligente Eingebettete Systeme, Institut für Informatik, Universität Freiburg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Breast cancer patients with a local advanced mamma carcinoma, able to communicate and express emotional situation in German language.
Exclusion criteria
Exclusion criteria: Other tumors, mental or physical limitations, which impede answering surveys or participation in assessments, life-threatening other diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monitor Stress and Emotional state, with following instruments: a. NCCN Distress Thermometer and Problem list based on NCCN Guidelines Version 2.2022 : 1-item instrument with 0-10 scale and the Problem list. The checklist includes problems from 5 areas of life: practical, family, emotional, spiritual/religious, and physical problems. b. Self-Assessment Manikin (SAM) with a scale from 1 to 5 for three aspects: S: Sentiment – Question: What is your affective state at the moment: Answer scale: from Negative (1) to Positive (5)? A: Arousal – Question: How aroused are you at the moment? Answer scale: from doziness/boredom (1) to highly aroused (5)? M: Dominance – Question: What is your relation to the situation at the moment Answer scale: is the situation more than you can handle (1) or are you in control of yourself (5)? c. Stress and Heartrate measurement of patient with pulsoximeter monitoring and photoplethysmogram (PPG), similar to optical heartbeat sensing in a smartwatch. It is a CE certified device. EmbracePlus smart watch part of Empatica Health Monitoring Platform, the latest sensing system for stress and affect. Certifications include: ISO 13485:2016 Medical Devices; European Union Medical Device Directive (EU MDD) 93/42/EEC, with CE Certificate number: 1876/MDD2, and US FDA's Quality System Regulations (QSRs), other certifications available in this link. d. Observational measurement from clinician of affect and distress states will be collected per moment through a 1-5 scale (VAS) 1: patient no distress, 6: patient highly distressed | — |
Secondary
| Measure | Time frame |
|---|---|
| Personal Factors for stress, with following instruments: a. Personal sociodemographic data of patient in an electronic page b. Interview at the end of the Radiotherapy sessions c. Patient self-report of related variables for potential correlation and prediction: Patient will mark any factors in electronic form that apply for them: Question: Do any of these factors affect you at the moment? A)Stress factors: Internal bio-physical distress factors: low water intake, low nutrient level, low sunlight and fresh air exposure, pain, tiredness. B)Negative affect factors:External factors: delayed event information, poor patient-staff interaction, reduced physical space, uncomfortable interaction with medical technology. Internal factors: reduced social support contact C) Positive affect factors: External factors: positive patient-staff interaction, calming physical space, and comfortable interaction with medical technology. Internal factors: positive social contact. | — |
Countries
Germany
Contacts
Public ContactOliver Amft
Intelligente Eingebettete Systeme, Institut für Informatik, Universität Freiburg
Outcome results
None listed