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NCT Number: NCT01830075

The Life InSight Application Study (LISA)

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.

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Key information

Conditions

Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultations

Behavioral

The patients receive two consultations with a spiritual counsellor. In these consultations life evens and life goals are discussed.

Primary outcomes

  1. Quality of life

    Time frame: 4 months

    The EORTC QLQ C15 is a questionnaire developed to assess the quality of life of palliative cancer care patients.

  2. Spiritual well being

    Time frame: 4 months

    FACIT-Sp-12: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale

Secondary outcomes

  1. patients empowerment

    Time frame: 4 months

    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.

  2. spirituality

    Time frame: 4 months

    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.

Other outcomes

  1. anxiety and depression

    Time frame: 4 months

    Changes in patients' perspective on satisfaction with life will be measured by the Diener Satisfaction with Life Scale. Furthermore, asfeelings of anxiety and depression may come up when patients realize the limited amount of time that is left to achieve life goals, feelings of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale.

  2. patients' health consumption

    Time frame: 4 months

    Patients' health consumption is assessed according to a shortened and for this study adjusted version of the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness.

  3. patients'satisfaction with the intervention

    Time frame: 4 months

    Finally, we will explore patients' satisfaction with the intervention by a telephone interview using a study-specific topic list.

  4. satisfaction with life

    Time frame: 4 months

    Changes in patients' perspective on satisfaction with life will be measured by the Diener Satisfaction with Life Scale

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Dutch Cancer Society
  • Janssen, LP

Registry information

Official study 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

Acronym: LISA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2013
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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