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Pilot-Studie I: Verontrustende informatie, Psycho-fysiologie en Geheugen.

A pilot study of Study I: Distressing information, the Psychophysiological response and Recall.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22694
Enrollment
40
Registered
2013-11-15
Start date
2013-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doctor-patient communication in oncology bad news consultations.

Interventions

In (PILOT) Study I an experimental design will be used, involving the continuous assessment of psychophysiological responses of a group of participants (analogue patients) while watching a scripted vi

Sponsors

Academic Medical Center (AMC), Amsterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 1 (cancer patients / -survivors) In order to be eligible to participate in Group 1 of this pilot study, a subject must meet all of the following criteria: -Informed consent; -Having had cancer or being treated for cancer with a curative intent, with the exception of having (had) esophageal cancer. -Diagnosed with cancer within a time span of 1 to 5 years ago; Group 2 (healthy individuals) In order to be eligible to participate in Group 2 of this pilot study, a subject must meet all of the following criteria: -Informed consent; -‘Healthy’, meaning: •Never having had cancer •Currently not visiting any medical specialist for another serious medical condition (e.g. COPD, colon diseases, etc.)

Exclusion criteria

Exclusion criteria: Subjects are not eligible if one or more of the following criteria apply: -Those who suffer from cardiovascular disease and/or hypertension (to prevent interference with psycho-physiological measurements); -Those who suffer from an endocrine disorder, e.g. diabetes mellitus (to prevent interference with cortisol measures); -Smoking > 20 cigarettes per week (to prevent interference with cortisol measures); -No current use of corticosteroid containing medication, including ointments (to prevent interference with cortisol measures); -Subjects who are not literate in Dutch; -Subjects who have an uncorrectable hearing or vision problem; -Age < 18 years

Design outcomes

Primary

MeasureTime frame
- Psychophysiological responses: our set of physiological measures samples broadly from the electrodermal, cardiovascular system and hormonal system.

Secondary

MeasureTime frame
- Recall of information - Self reported emotional distress - Identification with the patient in the video and engagement in the video story.

Contacts

Public ContactLeonie Visser

AMC Medical Research Dep. of Medical Psychology, J3-219 Meibergdreef 9

n.c.visser@amc.uva.nl+31 (0) 20 56 68737

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)