The Life InSight Application Study (LISA)

NCT01830075 | Completed

• 1 other identifier: W12-143#12.17.0161
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• patients empowerment

  4 months

• spirituality

  4 months

Other Outcomes (4)

• anxiety and depression

  4 months

• patients' health consumption

  4 months

• patients'satisfaction with the intervention

  4 months

Study Arms (2)

Control group

NO INTERVENTION

The control group receives care as usual.

Consultations

EXPERIMENTAL

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

Behavioral: Consultations

Interventions

Consultations BEHAVIORAL

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

Consultations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dutch Cancer Society: collaborator
• Janssen, LP: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 30516096 DERIVED

• 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.

  PMID: 23889978 DERIVED

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Hanneke WM Laarhoven, van, MD, PhD

  Acadamic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 12, 2013
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

NL (1)