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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103737
• Other study ID #: ONCOTIC-II
• Status: Completed
• Phase: N/A
• First received: March 22, 2017
• Last updated: March 31, 2017
• Start date: January 2012
• Est. completion date: August 31, 2013

Study information

• Verified date: March 2017
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 31, 2013
• Est. primary completion date: August 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Virtual Reality (VR) and Reminiscence Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Rosa María Baños Rivera	Hospital Clínica Benidorm, Universidad Politécnica de Valencia, Universitat Jaume I

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)		Change from baseline to 1 week
Primary	Fordyce Happiness Scale (Fordyce, 1988).		Change from baseline to 1 week
Secondary	Visual Analog Scale: Mood.	Subjective mood change after each session.	4 days along 1 week
Secondary	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
Secondary	Visual Analog Scale: Physical Discomfort. Change pre-post sessions.	fatigue, pain and nausea-vomiting (5-point Likert scale)	4 days along 1 week
Secondary	Visual Analog Scale: Satisfaction with the Session	pleasantness and perceived usefulness (5-point Likert scale)	4 days along 1 week
Secondary	Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972).	satisfaction, recommendation, utility and discomfort (5-point Likert scale)	1 week
Secondary	Distress Thermometer (Roth et al., 1998).		Change from baseline to 1 week
Secondary	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