Clinical trial NCT01830075: The Life InSight Application Study (LISA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Janssen, LP
First posted: 2013-04-12
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 one's 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.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age with advanced cancer not amenable to curative treatment.
* Life expectancy ≥ 6 months.

Exclusion Criteria:

* Karnofsky Performance Score \< 60.
* Insufficient command of the Dutch language to fill out Dutch questionnaires.
* Current psychiatric disease

Primary outcomes:
measure: Quality of life
timeFrame: 4 months
measure: Spiritual well being
timeFrame: 4 months
Secondary outcomes:
measure: patients empowerment
timeFrame: 4 months
measure: spirituality
timeFrame: 4 months
Other outcomes:
measure: anxiety and depression
timeFrame: 4 months
measure: patients' health consumption
timeFrame: 4 months
measure: patients'satisfaction with the intervention
timeFrame: 4 months
measure: satisfaction with life
timeFrame: 4 months
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
affiliation: Acadamic Medical Center
name: Hanneke WM Laarhoven, van, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruizinga R, Scherer-Rath M, Schilderman JB, Hartog ID, Van Der Loos JP, Kotze HP, Westermann AM, Klumpen HJ, Kortekaas F, Grootscholten C, Bossink F, Schrama J, Van De Vrande W, Schrama NA, Blokland W, De Vos FY, Kuin A, Meijer WG, Van Oijen MG, Sprangers MA, Van Laarhoven HW. An assisted structured reflection on life events and life goals in advanced cancer patients: Outcomes of a randomized controlled trial (Life InSight Application (LISA) study). Palliat Med. 2019 Feb;33(2):221-231. doi: 10.1177/0269216318816005. Epub 2018 Dec 5.
citation: Kruizinga R, Scherer-Rath M, Schilderman JB, Sprangers MA, Van Laarhoven HW. The life in sight application study (LISA): design of a randomized controlled trial to assess the role of an assisted structured reflection on life events and ultimate life goals to improve quality of life of cancer patients. BMC Cancer. 2013 Jul 26;13:360. doi: 10.1186/1471-2407-13-360.