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OpenTrials
Completed

NCT Number: NCT03103737

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality (VR) and Reminiscence Intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rosa María Baños Rivera

Other

Collaborators

  • Hospital Clínica Benidorm
  • Universitat Jaume I
  • Universitat Politècnica de València

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2017
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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