Promotion of Emotional Well-being in Hospitalized Cancer Patients by Information and Communication Technologies (ICTs)
Evaluation of a Brief Psychological Intervention That Uses ICTs to Improve Well-being in Hospitalized Cancer Patients
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Jan 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2013
CompletedFirst Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedApril 6, 2017
March 1, 2017
1.7 years
March 22, 2017
March 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Visual Analog Scale: Mood.
4 days along 1 week
Visual Analog Scale: Emotional State. Change pre-post sessions.
4 days along 1 week
Visual Analog Scale: Physical Discomfort. Change pre-post sessions.
4 days along 1 week
Visual Analog Scale: Satisfaction with the Session
4 days along 1 week
Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972).
1 week
- +2 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALPsychological intervention composed by four sessions along 1 week. Participants can interact with virtual environments and a multimedia system for reminiscence purposes.
Control
NO INTERVENTIONParticipants receive the medical treatment deliver by the hospital. After one week, they have the possibility to receive the psychological intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- adults with any cancer diagnosis
- hospitalized for at least 1 week
- Karnofsky functional state ≥50
- life expectancy ≥2 months
You may not qualify if:
- serious psychopathology
- cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rosa María Baños Riveralead
- Hospital Clínica Benidormcollaborator
- Universitat Jaume Icollaborator
- Universitat Politècnica de Valènciacollaborator
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
March 22, 2017
First Posted
April 6, 2017
Study Start
January 1, 2012
Primary Completion
August 31, 2013
Study Completion
August 31, 2013
Last Updated
April 6, 2017
Record last verified: 2017-03