Viewing Study NCT01830075



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Study NCT ID: NCT01830075
Status: COMPLETED
Last Update Posted: 2016-07-27
First Post: 2013-04-05

Brief Title: The Life InSight Application Study LISA
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization: Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA

Study Overview

Official Title: The Life InSight Application Study the Role of an Assisted Structured Reflection on Life Events and Ultimate Life Goals to Improve Quality of Life of Cancer Patients
Status: COMPLETED
Status Verified Date: 2016-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LISA
Brief Summary: Background

It is widely recognised that spiritual care plays an important role in physical and psychosocial well-being of cancer patients but there is little evidence based research on the effects of spiritual care The investigators will conduct the first randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients

Design

Based on the findings of the investigators previous research the investigators have developed a brief interview model that allows spiritual counselors to explore explicate and discuss life events and ultimate life goals with cancer patients To support the interview the investigators created an e-application for a PC or a tablet To examine whether this assisted reflection improves quality of life the investigators will conduct a randomized trial Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group The intervention group will have two consultations with a spiritual counselor using the interview scheme supported by the e-application The control group will receive care as usual At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life spiritual wellbeing empowerment satisfaction with life anxiety and depression and health care consumption

Discussion

Having insight into ones ultimate life goals may help to cope with a life event such as cancer This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients quality of life and spiritual well being The intervention is brief and based on concepts and skills that spiritual counselors are familiar with it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None