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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Virtual Reality (VR) and Reminiscence Intervention

• Registration Number: NCT03103737
• Lead Sponsor: Rosa María Baños Rivera

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-08-31
• Study Completion: 2013-08-31
• Status Verified: 2017-03
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Study First Posted: 2017-04-06
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Reality (VR) and Reminiscence Intervention	Psychological intervention composed by four sessions along 1 week. Participants can interact with virtual environments and a multimedia system for reminiscence purposes.

Primary Outcome Measures

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

Secondary Outcome Measures

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