**3. The main concept and aims of the pilot study**

#### **3.1. Dignity therapy: a concept of the study**

A concept of the study is dignity therapy (DT), which has international scientific recognition (as safe and effective supportive therapy), but is unknown in Eastern and Central Europe and should be explored in research (e.g., first in a pilot study and then in RCT) among hospice patients in Eastern and Central European countries.

The pilot study will collect preliminary data, prior to conducting a larger randomized controlled trial (RCT) that will investigate the correlations (impact) of dignity therapy (DT) intervention with quality of life (QoL), and possible reduction of distress and suffering in the Eastern and Central European hospice patients. Also, for caregivers of the study patients, the effects of DT intervention, in relation to their psychophysical health condition, during bereavement will be explored. Simultaneously, the caregivers will be asked to provide their opinions about the DT intervention.

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 bereavement.

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

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 suffer-

ing patients at the end-of-life stage in Eastern and Central European countries.

**and civilizational progress**

112 Clinical Trials in Vulnerable Populations

and Central Europe.

progress oriented on universal human values.

**3. The main concept and aims of the pilot study**

**3.1. Dignity therapy: a concept of the study**

opinions about the DT intervention.

patients in Eastern and Central European countries.

**2.4. The importance of the study results for the development of scientific discipline** 

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

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

A concept of the study is dignity therapy (DT), which has international scientific recognition (as safe and effective supportive therapy), but is unknown in Eastern and Central Europe and should be explored in research (e.g., first in a pilot study and then in RCT) among hospice

The pilot study will collect preliminary data, prior to conducting a larger randomized controlled trial (RCT) that will investigate the correlations (impact) of dignity therapy (DT) intervention with quality of life (QoL), and possible reduction of distress and suffering in the Eastern and Central European hospice patients. Also, for caregivers of the study patients, the effects of DT intervention, in relation to their psychophysical health condition, during bereavement will be explored. Simultaneously, the caregivers will be asked to provide their The primary aims of this pilot study are as follows:


#### **3.3. The particular goals of RCT**

The particular goals of RCT are as follows:


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 setting: initial plan of the study**

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)).

The therapy will be guided by therapists (working in teams with postgraduate students). CV consists of three tape-recorded + one final sessions. The main goal of the CV intervention is to invite patients to reflect on their most important accomplishments, roles in their lives, or other things that they would most want to be remembered. Upon completion of the intervention, the recorded sessions will be transcribed and edited to provide a clear narrative CV document (album) that can be given to a person selected by the patient (e.g., family member, friend), or donated to hospice (as an option). The proposed CV intervention, in addition to the original DT model, introduces a patient-caregiver "team" approach in which both the patient and the caregiver (usually a close family member) actively participate in creation of the final DT document (CV album) (e.g., the patient is mostly involved with the 1st, "conceptual" part, and the caregiver is helping with the 2nd "executive" part, by "gathering evidence" (such as photos, for the CV album).

Exclusion criteria for patients (Pts):

Inclusion criteria for caregivers: • Signed informed consent form

Exclusion criteria for caregivers:

*4.1.3. Study outcome measures (OM) and tools*

Outcome measures for hospice patients (Pts):

**2.** Health related quality of life: (HRQol)

tient Health Questionnaire (PHQ 9)

caregivers. CV intervention includes four sessions:

the patient, and again 2 weeks later)

Outcome measures for caregivers:

The main study procedures:

**1.** introduction (60'); **2.** intake session (60'); **3.** editing session (60'); **4.** final session (60')

tancy < 6 months

• ≥18 years of age

care

• Cognitive impairment (e.g., dementia, delirium)

• Deterioration of illness precluding further participation in the study

• Physical or mental illness precluding participation in the study

• Taking care of a close relative admitted to hospice (stationary or home), with life expec-

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

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

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• A desire to alleviate suffering and distress of the terminally ill relative, beyond standard

**1.** Psychological distress: measured by the Hospital Anxiety and Depression Scale (HADS)

(Time frame: Pre-postintervention (when the final study document = CV album is received by

**1.** Psychophysical condition: measured by General Health Questionnaire (GHQ 12) and Pa-

**2.** Brief survey presenting caregivers' opinions about the benefits and possible concerns rel-

Orientation meeting for the study therapists, investigators, coordinators, hospice staff, and

(Time frame: 1, pre-postintervention, and again 2 weeks later; 2, with the last evaluation)

evant to the dignity therapy (in form of the CV), added to standard PC
