The Life InSight Application Study (LISA)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Quality of Life

Treatments: Behavioral: Consultations

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01830075

W12-143#12.17.0161

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

153 participants in 2 patient groups

Control group

No Intervention group

Description:

The control group receives care as usual.

Consultations

Experimental group

Description:

An intervention of two consultations with a spiritual counselor supported by an e-application.

Treatment:

Behavioral: Consultations