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The Life InSight Application Study (LISA) (LISA)

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ClinicalTrials.gov Identifier: NCT01830075
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : July 27, 2016
Sponsor:
Collaborators:
Dutch Cancer Society
Janssen, LP
Information provided by (Responsible Party):
H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease Intervention/treatment Phase
Quality of Life Behavioral: Consultations Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : May 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830075


Locations
Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Cancer Society
Janssen, LP
Investigators
Principal Investigator: Hanneke WM Laarhoven, van, MD, PhD Acadamic Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H.W.M. van Laarhoven, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01830075     History of Changes
Other Study ID Numbers: W12-143#12.17.0161
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016