Promotion of Emotional Well-being in Hospitalized Cancer Patients by Information and Communication Technologies (ICTs)

Study Overview
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Brief Summary
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The aim of this study is to test the efficacy of a brief psychological intervention composed by two therapeutic modules (virtual environments and reminiscence techniques) for the promotion of wellbeing of hospitalized adult cancer patients. Participants are randomly assigned to 2 conditions: intervention condition and control condition.

Official Title
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Evaluation of a Brief Psychological Intervention That Uses ICTs to Improve Well-being in Hospitalized Cancer Patients

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Virtual Reality (VR) and Reminiscence Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults with any cancer diagnosis hospitalized for at least 1 week Karnofsky functional state ≥50 life expectancy ≥2 months Exclusion Criteria: serious psychopathology cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Psychological intervention composed by four sessions along 1 week. Participants can interact with virtual environments and a multimedia system for reminiscence purposes. | Behavioral: Virtual Reality (VR) and Reminiscence Intervention<br>* First and third sessions are dedicated to remember positive and meaningful personal experiences. Second and fourth sessions are oriented to positive emotions by the use of VR. Participants can choose the virtual environment to work with.<br>|
| No Intervention: Control<br>Participants receive the medical treatment deliver by the hospital. After one week, they have the possibility to receive the psychological intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986) |  | Change from baseline to 1 week | 
| Fordyce Happiness Scale (Fordyce, 1988). |  | Change from baseline to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale: Mood. | Subjective mood change after each session. | 4 days along 1 week | 
| Visual Analog Scale: Emotional State. Change pre-post sessions. | positive affect, negative affect, well-being and calmness (5-point Likert scale) | 4 days along 1 week | 
| Visual Analog Scale: Physical Discomfort. Change pre-post sessions. | fatigue, pain and nausea-vomiting (5-point Likert scale) | 4 days along 1 week | 
| Visual Analog Scale: Satisfaction with the Session | pleasantness and perceived usefulness (5-point Likert scale) | 4 days along 1 week | 
| Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972). | satisfaction, recommendation, utility and discomfort (5-point Likert scale) | 1 week | 
| Distress Thermometer (Roth et al., 1998). |  | Change from baseline to 1 week | 
| Time perception (based on Bayés et al., 1997). | Participants has to indicate the session duration (in minutes). An objective measure of the time lapse is also registered by the researcher. | 4 days along 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Well-being, Information and communication technologies, Hospital