**5. Conclusion**

main focus of the DT is to be able to better cope with stress and suffering, related to terminal

From a practical point of view, the pilot study and RCT will analyze the measured psychological parameters, which characterize daily distress and health-related quality of life (QoL). Similarly, for the caregivers, the parameters that characterize psychophysical health will be analyzed. These measurements are easily available and can be promptly and safely conducted in the hospice setting. In addition, the caregivers will complete a survey related to the DT

SG and CG will be compared using chi-square analysis for discrete data and independent *t*-tests for continuous data on demographics and baseline variables. For each outcome measure (except the caregivers' survey), the results of the DT intervention will be compared by analyses of covariance (ANCOVA) taking the postintervention measurement as dependent values. Respective baseline value of the outcome (V1) will served as a covariate. Within the statistical model, the group variable will serve as between-subject factor, and the postintervention measures as dependent factors. Statistical significance is set at the 0.05 level. The intention-to-treat principle will be used in this study. The CV transcript will be analyzed for content. All the statistical analyses will be conducted using the statis-

Usual palliative care in patients with terminal cancer includes medically indicated nonpharmacological therapy, combined with pharmacological comfort care (e.g., pain control) and holistic care, focusing on management of psychophysical and spiritual needs and personal care (e.g., skin care). Despite that many hospice patients suffer on a daily basis from loss of personal autonomy, dignity, as well as mental distress, depression, and anxiety, in addition

Safety, potential risk of the study: No risk/adverse effects to participants have been docu-

disease of the relative.

120 Clinical Trials in Vulnerable Populations

V# 4—Final (3 weeks).

*4.2.9. Statistical analysis*

tical program.

*4.2.10. Reference therapy*

to physical discomfort.

mented with regard to the DT intervention.

Schedule of the research visits.

V# 2—Intake/interview (1 week),

V# 3—Revision/edition (2 weeks),

V# 1—Orientation/introduction (0 week),

Abbreviations used in the schedule: V—visit.

intervention benefits or possible concerns.

*4.2.8. Study timeline*

In summary, dignity therapy (DT) (based on research evidence from international studies, published in scientific literature) represents a feasible, safe, and effective, patient-friendly approach, targeting end-of-life psychological problems. DT has a unique potential to help patients with terminal stages of cancer. In particular, DT can fulfill some unmet psychological and spiritual needs, help preserve psychophysical integrity, and distress, as well as support caregivers, during the bereavement period [3, 6, 11, 13]. Since DT is unknown in Eastern and Central Europe, the proposed pilot study, followed by RCT, will be the first step on the way to explore the DT intervention in research among hospice patients in this area.
