The Life InSight Application Study (LISA) (LISA)
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Noord-Holland
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Amsterdam, Noord-Holland, Pays-Bas
- Academic Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control group
The control group receives care as usual.
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Expérimental: Consultations
An intervention of two consultations with a spiritual counselor supported by an e-application.
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The patients receive two consultations with a spiritual counsellor.
In these consultations life evens and life goals are discussed.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of life
Délai: 4 months
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The EORTC QLQ C15 is a questionnaire developed to assess the quality of life of palliative cancer care patients.
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4 months
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Spiritual well being
Délai: 4 months
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FACIT-Sp-12: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale
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4 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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patients empowerment
Délai: 4 months
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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.
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4 months
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spirituality
Délai: 4 months
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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.
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4 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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anxiety and depression
Délai: 4 months
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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.
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4 months
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patients' health consumption
Délai: 4 months
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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.
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4 months
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patients'satisfaction with the intervention
Délai: 4 months
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Finally, we will explore patients' satisfaction with the intervention by a telephone interview using a study-specific topic list.
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4 months
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satisfaction with life
Délai: 4 months
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Changes in patients' perspective on satisfaction with life will be measured by the Diener Satisfaction with Life Scale
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4 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Hanneke WM Laarhoven, van, MD, PhD, Acadamic Medical Center
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- W12-143#12.17.0161
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