**2. Psychophysical and social importance of the study theme**

#### **2.1. State of the art relevant to knowledge on dignity therapy (DT) intervention in hospice setting**

In many palliative care programs, a significant progress in pain management and symptomatic control has been accomplished among patients with terminal stages of metastatic cancer. However, despite these advances, dignity-related issues, including loss of personal autonomy and sense of purpose in life, or feeling a burden to family represent common causes of spiritual suffering, psychological distress (e.g., anxiety and depression), and decreased quality of life (QoL) among hospice patients. To respond to this challenge, innovative strategies are necessary. One such exemplary intervention is called dignity therapy (DT) [9]. DT is a psychotherapeutic intervention that was developed by Prof. Chochinov and colleagues, in 2012, in Canada. The main goal of DT is to decrease emotional and spiritual suffering, enhance quality of life, and increase a sense of meaning and purpose of life among terminally ill patients near death. In particular, DT attempts to help such patients reflect upon things that are most meaningful to them, and collect these memories in form of the "final document" [9].

Dignity therapy question protocol (DTQP) is a set of standard questions that a therapist asks during an interview (conveniently conducted at the bedside) with the patient [10]. Evidence from recent research studies (conducted in Canada, Australia, and the USA) has revealed significant reduction of sense of suffering, depressed mood, and improvement in sense of dignity among terminally ill patients [11]. In summary, DT was found to be satisfactory to the patients, helpful to their relatives during grief period, and acceptable to the hospice personnel (e.g., better relations with patients and increased job satisfaction were reported) [12, 13].

#### **2.2. Justification of the study theme**

advanced stages of malignancy. Such patients are usually referred for palliative care services, and if their prognosis is estimated to be less than 6 months, they are often admitted to the hospice setting [1]. In case of an incurable metastatic cancer, in addition to multiple diseaserelated physical symptoms, many of such patients painfully experience loss of purpose in life and severe distress [2]. Although palliative care is designed to provide holistic comfort care, spiritual and psychosocial support until the end of life (and also during bereavement, for family members), several hospice patients still suffer from psychological distress and decreased

To fulfill these unmet needs, novel interventions, able to directly address psychosocial sources of distress, among the hospice patients are needed [3–5]. One such intervention is dignity therapy (DT), defined as a brief, individualized psychotherapy, applied for the purpose of relieving psychological distress at the end of life [6]. Based on scientific evidence from published research in this field, derived from international studies, DT has been shown to be a feasible and effective novel strategy that targets psychophysical suffering in terminally ill patients [7]. In particular, DT attempts to help such patients reflect upon issues that are most meaningful to them, and document them in form of the "final document" [8]. However, DT is unknown in Eastern and Central Europe, and thus should be explored among hospice

The study hypothesis is that the proposed pilot study will gather necessary information to create a foundation for a further randomized controlled trial (RCT) that will explore the correlations (or impact) of dignity therapy (DT) intervention with quality of life (QoL), and possible reduction of distress and suffering, among the hospice patients in Eastern and Central Europe.

It is expected that the patients in the DT intervention group (study group, SG) might have improved QoL, compared to the control group (CG), receiving a standard palliative care only. In addition, the caregivers of patients in the DT intervention group (SG) may also have improved QoL and psychophysical health condition during bereavement, compared to the

**2. Psychophysical and social importance of the study theme**

**2.1. State of the art relevant to knowledge on dignity therapy (DT) intervention** 

In many palliative care programs, a significant progress in pain management and symptomatic control has been accomplished among patients with terminal stages of metastatic cancer. However, despite these advances, dignity-related issues, including loss of personal autonomy and sense of purpose in life, or feeling a burden to family represent common causes of spiritual suffering, psychological distress (e.g., anxiety and depression), and decreased

quality of life (QoL).

110 Clinical Trials in Vulnerable Populations

patients in these countries.

**1.2. The study hypothesis**

control group (CG).

**in hospice setting**

The proposed novel pilot study is going to explore the correlations between the perceived distress (anxiety, sadness, and depression) and emotional suffering (related to terminal stages of cancer), and DT intervention (in form of the Calendarium Vitae, CV) in hospice patients.

An analysis of the data from this pilot study is going to answer the following research questions:


#### **2.3. Justification of the innovative character of the study**

Although many hospice patients suffer from psychological distress (anxiety and depression), they are usually not aware of potential benefits of the DT intervention. According to the scientific literature, implementation of DT, as one of the components of comprehensive palliative care, represents a manageable therapeutic approach to hospice population that might, to some extent, improve coping with end of life psychosocial distress, and alleviate mental and spiritual suffering. Therefore, DT—as an innovative, simple, safe, patient-friendly, and cost-effective option to fulfill unmet needs among growing population of hospice patients deserves an analysis in research. Moreover, it can be expected that in the future, depending on the preliminary study results, a possible implementation of DT, as a supportive care option, added to standard palliative care, could bring some beneficial effects for many suffering patients at the end-of-life stage in Eastern and Central European countries.

For the purpose of this study, a form of DT intervention, which is also called "Calendarium Vitae" (CV), involves both patients and (whenever possible) caregivers (participating as a team: patient and caregiver). The patients will be asked questions about their most important achievements, roles, and other important aspects of their life. In addition, CV intervention encourages patients to saying things to their loved ones that have remained unsaid. At the same time, CV invites the caregivers to contribute to the creation of the DT final document (CV album) that will be a "treasure" for the family and friends during

"Calendarium Vitae" for Hospice Patients and their Caregivers: A Pilot Study

http://dx.doi.org/10.5772/intechopen.70190

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• Test feasibility of the dignity therapy (DT) before conducting a larger randomized clinical

• Adapt the DT intervention to local health care circumstances (Eastern and Central Euro-

• Learn the caregiver perspectives with regard to the benefits and possible concerns of DT intervention, when provided as a therapeutic procedure, added to palliative care.

• To examine whether the addition of dignity therapy (DT) in form of the Calendarium Vitae (CV) to standard palliative care (PC) could reduce psychological distress (anxiety and depression) and augment quality of life among the hospice patients (Pts) in Eastern and

• To test whether the addition of the CV intervention (to standard PC for the patients) could

• To conduct a follow-up assessment of the caregiver psychophysical health (post 6–12

These findings will be compared to the results of the control group receiving standard PC.

**3.4. A possible adaptation of the pilot study into Eastern and Central European hospice** 

It is estimated that in this study, a total of about 100 patients diagnosed with an advanced neoplastic disease and poor prognosis (life expectancy < 6 months), who receive palliative care in the hospice, will be randomly assigned to either DT (CV) or PC in a 1:1 ratio. Patients will be prescreened and included to the study, if they report increased psychological distress (anxiety

or depression, based on the Hospital Anxiety and Depression Scale (HADS)).

trial (RCT) among hospice patients in Eastern and Central European countries.

bereavement.

**3.2. The primary aims of this pilot study**

pean hospice patients).

**3.3. The particular goals of RCT**

Central European countries.

**setting: initial plan of the study**

months).

The particular goals of RCT are as follows:

influence their caregiver's psychophysical health.

The primary aims of this pilot study are as follows:

#### **2.4. The importance of the study results for the development of scientific discipline and civilizational progress**

The results of the proposed project (as evidenced in a recent, substantial body of scientific literature in this field) will have a significant impact on the development of several scientific disciplines, such as psycho-oncology, psychology, medicine, nursing, rehabilitation, pedagogy, humanistic, or social sciences, as well as general civilizational progress, civilizational progress oriented on universal human values.

In addition, research infrastructure, created in this study, will provide a unique opportunity for education and training of students and postgraduates in psycho-oncology and related disciplines. Moreover, the project will create a support network and educational center for caregivers ("care for the caregivers"), hospice personnel and volunteers, as well as students or postgraduates, working on their MS degrees in the above-mentioned medical, psychological, social, pedagogical, or other disciplines related to the health care. On the basis of the above facts, exploring DT intervention as a potential component of multidisciplinary palliative care is justified in the hospice setting and merits support. In conclusion, research studies (both pilot and RCT) investigating various aspects of DT (in form of the CV intervention) should have a chance of being conducted in hospice patients in Eastern and Central Europe.
