NCT03995095

Brief Summary

This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality. A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

2.8 years

First QC Date

June 5, 2019

Last Update Submit

June 25, 2019

Conditions

Keywords

SpiritualityIntervention Study

Outcome Measures

Primary Outcomes (1)

  • Change in the dimension of spirituality (PRE and POST measures)

    This variable was assessed with the Spirituality questionnaire from the Spanish Society of Palliative Care (SECPAL). This questionnaire contains 8 items, and it provides scores from 0 to 32, where higher values represent a better outcome. In order to observe the change in the dimension of spirituality, it was measured at in two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).

    Baseline up to 4 weeks

Secondary Outcomes (2)

  • Change in resilience (PRE and POST measures)

    Baseline up to 4 weeks

  • Change in demoralization (PRE and POST measures)

    Baseline up to 4 weeks

Study Arms (2)

Control group

NO INTERVENTION

Group of participants that received usual psychological attention.

Experimental group

EXPERIMENTAL

Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).

Other: Therapeutic interview: kibo protocol

Interventions

The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be 18 or more years of age.
  • Being in advanced or terminal disease phase (following World Health Organization criteria).
  • To have preserved cognitive capacity.
  • To have signed the informed consent.

You may not qualify if:

  • a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de València

Valencia, 46010, Spain

Location

Related Publications (1)

  • Soto-Rubio A, Perez-Marin M, Rudilla D, Galiana L, Oliver A, Fombuena M, Barreto P. Responding to the Spiritual Needs of Palliative Care Patients: A Randomized Controlled Trial to Test the Effectiveness of the Kibo Therapeutic Interview. Front Psychol. 2020 Aug 21;11:1979. doi: 10.3389/fpsyg.2020.01979. eCollection 2020.

Study Officials

  • Pilar Barreto Martin, PhD

    Universitat de València

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesora Titular

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 21, 2019

Study Start

March 1, 2016

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations