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

Cancer patients are confronted with a diagnosis and subsequent treatment that may have a large impact on their life perspective [13, 14]. Their life lines are suddenly disrupted, which necessitates a reinterpretation of their lives. This experience is called experience of contingency [12]. Experiences of contingency prompt people to shape a meaningful relation to the situations they are confronted with. Meaningful implies: acting in such a way that it logically and plausibly connects to one’s actions in the past, as well as to desires, wishes and needs for the future [15, 16]. In a traditional society, the contingency of action and choice was limited [13], but nowadays people have become individuals with their own personal, biographical story that they have to construct and justify by themselves [17, 18]. They increasingly feel obliged to shape their own framework of interpretation for situations they are confronted with. Shaping such a framework of interpretation can be facilitated by the construction of a narrative [19, 20]. A narrative configures separate events into an intelligible whole [20]. It creates a temporal coherence whereby a so-called plot links past, present and future to one another and to the personal goals that people pursue. In confrontation with a contingent situation an extra narrative effort is required to construct a new framework of interpretation which fits with one’s ultimate life goals [21].

In the way people react to the experience of contingency and the stories people tell about their life events, we can decipher the underlying life goals [22]. Personal goals express what people find really important. They are the intrinsic source of human action [20, 23]. A distinction can be made between instrumental and ultimate life goals [24]. Instrumental goals refer directly to actions and the way actions are carried out, whereas more abstract goals provide information on the purpose or implications of actions [25]. Instrumental goals can be achieved in order to reach ultimate goals [26]. Unlike instrumental goals, ultimate life goals locate concrete situations in a person’s mental and behavioral framework that forms the core of self-identity [24]. They are irreplaceable in that they give meaning to our lives and without them our lives become meaningless [27]. However, in the course of one’s life, goals that give meaning may change. A reconstruction of the ultimate life goals in confrontation with contingency could assist patients to (re)access their own resources and come to terms with the unexpected aspects of life, ultimately improving their quality of life [28‐30].

We have developed a semi-structured interview model for the interpretation of contingent life events in life stories, based on literature on the experiences of contingency and the importance of ultimate life goals. In this interview we inquire into (a) the life events, (b) ultimate life goals, (c) the interpretation of contingent life events (d) reconstruction of life story. Since 2008 this interview model has been used in various populations, including mentally handicapped people, young people with problem behavior, individuals > 30 years, highly qualified young people in their twenties, Zen meditation trainees, volunteers in hospices, cancer patients, primary school teachers, and asylum seekers [24]. The respondents were from a religious and non-religious background. In all populations, the interviews were evaluated positively by most of the respondents. They did not experience the semi-structured nature of the interview as a drawback and frequently indicated that it was a very special experience to reconstruct their life stories in collaboration with an interviewer. In the experimental arm of our randomized study we will use this interview model for an assisted, structured reflection on contingent life events and ultimate life goals, which will be supported by a newly developed e-application. The assisted reflection is carried out in two consultations with a spiritual counsellor. The counsellor analyses the first consultation in the interim and discusses this analysis with the patient during the second consultation (Table 1).

The primary aim of our study is to improve quality of life and spiritual wellbeing. We will conduct a mixed design measures ANOVA to detect differences between the control-group and the intervention-group over pre-, post- and follow-up measurement. To detect a small effect (effect size f = .10) with statistical power 80%, alpha 5%, and a correlation between repeated assessments of r = .63, we need a sample of 122 patients. With an expected drop out of 20%, we will include 153 patients.

Randomization will be performed on-line via a secure internet facility in a 1:1 ratio by the TENALEA Clinical Trial Data Management System using randomly permuted blocks with maximum block size 4 within strata formed by nine spiritual counsellors. The researcher contacts the randomization website after patients have signed informed consent. The researcher enters the patient into the randomization program linked to the spiritual counsellor of the patients' hospital. In case in a specific hospital more than one spiritual counsellor is involved in the study a counsellor from that hospital is randomly allocated to the patient. Then the researcher receives the random treatment allocation (intervention versus control) for the patient.

Seven hospitals accepted the invitation to join the study. Participating hospitals are two academic hospitals: the Academic Medical Centre in Amsterdam, University Medical Centre Utrecht in Utrecht. One categorical hospital: Antoni van Leeuwenhoek Ziekenhuis, and four local hospitals: Onze Lieve Vrouwe Gasthuis in Amsterdam, Elkerliek Ziekenhuis in Helmond, Westfriesgasthuis in Hoorn, and Spaarneziekenhuis in Hoofddorp.

The Medical Ethics Review Committee of the Academic Medical Centre Amsterdam confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to our study and therefore an official approval of this study by the committee was not required. (Letter, June, 27^th,, 2012)

This study is funded by The Dutch Cancer Society/Alpe d’HuZes and Janssen Pharmaceutical Companies.