The Life InSight Application Study (LISA)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Quality of Life

Intervention / Treatment
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* Behavioral: Consultations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group receives care as usual. | |
| Experimental: Consultations<br>An intervention of two consultations with a spiritual counselor supported by an e-application. | Behavioral: Consultations<br>* The patients receive two consultations with a spiritual counsellor. In these consultations life evens and life goals are discussed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The EORTC QLQ C15 is a questionnaire developed to assess the quality of life of palliative cancer care patients. | 4 months | 
| Spiritual well being | FACIT-Sp-12: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients empowerment | Patient empowerment is becoming more and more important, both from health care professionals' and from patients' perspective. The patients in the intervention arm of our study will reconstruct a life story and also define their life goals and their intention for the future. This can lead to a feeling of more empowerment to undertake actions which are important to the patient. We will assess patients' empowerment with a Dutch version of the Pearlin Mastery Scale developed by Pearlin en Schooler (1978). The Pearlin Mastery Scale measures the extent to which individuals perceive themselves in control of forces that significantly impact their lives. It consists of a 7-item scale. In previous studies, the instrument yielded satisfactory psychometric properties. | 4 months | 
| spirituality | Furthermore, as time patients' view on spirituality can change over time due to the intervention, we will measure spirituality by the Spiritual Attitude en Interests List (SAIL), developed by the Helen Dowling Institute in the Netherlands. The SAIL is a multidimensional questionnaire for studying spiritual experiences of religious and nonreligious people. Mean Cronbach's alphas ranged in research from .73 to .86. | 4 months |