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

March 31, 2017 updated by: Rosa María Baños Rivera

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.
No Intervention: Control
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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale: Mood.
Time Frame: 4 days along 1 week
Subjective mood change after each session.
4 days along 1 week
Visual Analog Scale: Emotional State. Change pre-post sessions.
Time Frame: 4 days along 1 week
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.
Time Frame: 4 days along 1 week
fatigue, pain and nausea-vomiting (5-point Likert scale)
4 days along 1 week
Visual Analog Scale: Satisfaction with the Session
Time Frame: 4 days along 1 week
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).
Time Frame: 1 week
satisfaction, recommendation, utility and discomfort (5-point Likert scale)
1 week
Distress Thermometer (Roth et al., 1998).
Time Frame: Change from baseline to 1 week
Change from baseline to 1 week
Time perception (based on Bayés et al., 1997).
Time Frame: 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.
4 days along 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosa María Baños Rivera

Collaborators

Universitat Jaume I
Universitat Politècnica de València
Hospital Clínica Benidorm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

August 31, 2013

Study Completion (Actual)

August 31, 2013

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ONCOTIC-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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