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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103737
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
Hospital Clínica Benidorm
Universitat Jaume I
Universitat Politècnica de València
Information provided by (Responsible Party):
Rosa María Baños Rivera, University of Valencia

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Virtual Reality (VR) and Reminiscence Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Brief Psychological Intervention That Uses ICTs to Improve Well-being in Hospitalized Cancer Patients
Actual Study Start Date : January 2012
Actual Primary Completion Date : August 31, 2013
Actual Study Completion Date : August 31, 2013

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.



Primary Outcome Measures :
  1. 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 ]
  2. Fordyce Happiness Scale (Fordyce, 1988). [ Time Frame: Change from baseline to 1 week ]

Secondary Outcome Measures :
  1. Visual Analog Scale: Mood. [ Time Frame: 4 days along 1 week ]
    Subjective mood change after each session.

  2. 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)

  3. 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. Visual Analog Scale: Satisfaction with the Session [ Time Frame: 4 days along 1 week ]
    pleasantness and perceived usefulness (5-point Likert scale)

  5. 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)

  6. Distress Thermometer (Roth et al., 1998). [ Time Frame: Change from baseline to 1 week ]
  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Rosa María Baños Rivera, Full Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03103737    
Other Study ID Numbers: ONCOTIC-II
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosa María Baños Rivera, University of Valencia:
Well-being
Information and communication technologies
Hospital