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CancerNCT03103737

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

A study testing Virtual Reality (VR) and Reminiscence Intervention in people with Cancer, run by Rosa María Baños Rivera.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Virtual Reality (VR) and Reminiscence Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Jan 2012to 31 Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults with any cancer diagnosis
  • hospitalized for at least 1 week
  • Karnofsky functional state ≥50
  • life expectancy ≥2 months

Who cannot join

  • serious psychopathology
  • cognitive impairment

About this study

Official title: 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.

Conditions
Cancer
Being tested
Virtual Reality (VR) and Reminiscence Intervention
Keywords
Well-being, Information and communication technologies, Hospital
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality (VR) and Reminiscence InterventionBehavioural

    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.

Study groups in NCT03103737
Study groupRoleWhat they receive
InterventionExperimentalPsychological intervention composed by four sessions along 1 week. Participants can interact with virtual environments and a multimedia system for reminiscence purposes.
Receives: Behavioral: Virtual Reality (VR) and Reminiscence Intervention
ControlNo interventionParticipants receive the medical treatment deliver by the hospital. After one week, they have the possibility to receive the psychological intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)

    Measured: Change from baseline to 1 week

  2. Fordyce Happiness Scale (Fordyce, 1988).

    Measured: Change from baseline to 1 week

Secondary outcomes (7)

  1. Visual Analog Scale: Mood.

    Subjective mood change after each session.

    Measured: 4 days along 1 week

  2. Visual Analog Scale: Emotional State. Change pre-post sessions.

    positive affect, negative affect, well-being and calmness (5-point Likert scale)

    Measured: 4 days along 1 week

  3. Visual Analog Scale: Physical Discomfort. Change pre-post sessions.

    fatigue, pain and nausea-vomiting (5-point Likert scale)

    Measured: 4 days along 1 week

  4. Visual Analog Scale: Satisfaction with the Session

    pleasantness and perceived usefulness (5-point Likert scale)

    Measured: 4 days along 1 week

  5. Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972).

    satisfaction, recommendation, utility and discomfort (5-point Likert scale)

    Measured: 1 week

  6. Distress Thermometer (Roth et al., 1998).

    Measured: Change from baseline to 1 week

  7. 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.

    Measured: 4 days along 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2017
  2. Study startJan 2012
  3. Primary completion31 Aug 2013
  4. Study completion31 Aug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03103737
Sponsor's protocol ID
ONCOTIC-II
Status last verified
Mar 2017
First submitted
22 Mar 2017
Last updated
6 Apr 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality (VR) and Reminiscence Intervention in people with Cancer, run by Rosa María Baños Rivera.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03103737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.

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