**4. Study methodology**

#### **4.1. Methodology and implementation of the pilot study**

Study design RCT: Interventional, experimental, prospective, randomized, controlled, parallel, with a follow-up (6–12 months).

Study group (SG): Hospice patients (with caregivers, women, and men, aged >18, with preserved cognitive skills, diagnosed with advanced cancer, with life expectancy <6 months), receiving palliative care at the stationary or home hospice setting, plus DT. Control group (CG) (similar in size to the SG), hospice patients (as in SG), receiving standard palliative care at the stationary or home hospice setting.

#### *4.1.1. Study intervention*

Calendarium Vitae (CV), as a form of DT, involves patients and caregivers (as teams) asking the patients questions about their most important achievements, roles, and other important aspects of life. Simultaneously, CV invites the caregivers to contributing to the creation of the DT final document (CV album).

#### *4.1.2. Eligibility criteria*

Inclusion criteria for patients (Pts):


Exclusion criteria for patients (Pts):


Inclusion criteria for caregivers:


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,

Study design RCT: Interventional, experimental, prospective, randomized, controlled, paral-

Study group (SG): Hospice patients (with caregivers, women, and men, aged >18, with preserved cognitive skills, diagnosed with advanced cancer, with life expectancy <6 months), receiving palliative care at the stationary or home hospice setting, plus DT. Control group (CG) (similar in size to the SG), hospice patients (as in SG), receiving standard palliative care

Calendarium Vitae (CV), as a form of DT, involves patients and caregivers (as teams) asking the patients questions about their most important achievements, roles, and other important aspects of life. Simultaneously, CV invites the caregivers to contributing to the creation of the

for the CV album).

**4. Study methodology**

114 Clinical Trials in Vulnerable Populations

*4.1.1. Study intervention*

*4.1.2. Eligibility criteria*

• ≥18 years of age

• Preserved cognitive skills

DT final document (CV album).

Inclusion criteria for patients (Pts): • Signed informed consent form

• Diagnosis of advanced cancer, with life expectancy < 6 months

• Receiving palliative care at the hospice (stationary or home)

lel, with a follow-up (6–12 months).

at the stationary or home hospice setting.

**4.1. Methodology and implementation of the pilot study**

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

Exclusion criteria for caregivers:

• Physical or mental illness precluding participation in the study

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

Outcome measures for hospice patients (Pts):


(Time frame: Pre-postintervention (when the final study document = CV album is received by the patient, and again 2 weeks later)

Outcome measures for caregivers:


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

The main study procedures:

Orientation meeting for the study therapists, investigators, coordinators, hospice staff, and caregivers. CV intervention includes four sessions:


(each session could be extended to 2 hours, depending on the patient's condition)

All sessions will be conducted by a team, including a therapist (e.g., a psychologist, or a physician) and a student (a graduate student preparing MS thesis, or a specially trained hospice volunteer (optional))

advertisements in local newspapers, and via the Internet. Interested patients (and their caregivers) will receive detailed information regarding the DT course and will be screened (with the HADS). First-inclusion and exclusion criteria will be checked in a standardized interview, and then the patients (and the caregivers) will have a brief introduction conducted by the

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It is estimated that the number of participants screened for the study should be approximately 100, in order to enroll into the study about 10–20 patients with terminal cancer, for the study group (SG), and about 10–20 patients, for the control group (CG). Eligible candidates will sign an ICF (after explanations about the study principles and voluntary participation in it) and

In 2017, about 100 adult patients, who suffer from terminal cancer (diagnosed at least 3 months prior to entering of the pilot study) will be randomized to a study group or control

The study group (SG) (*N* = 10–20) will be composed of women and men with terminal cancer, with <6 months prognosis, aged >18 years, treated with a standard palliative care will receive

The control group (CG) (similar in size, age, diagnosis, and prognosis to the SG) will be com-

Duration of the study DT intervention equals to 2 weeks, and includes: 2-week DT process,

The patients in the CG will be receiving PC only, and filling out research questionnaires.

The pilot study participants in both groups will continue their regular, standard PC.

*4.2.6. Management of randomized controlled trial (RCT) examining DT intervention among* 

After completing of the pilot study, a subsequent step of recruitment of the volunteersparticipants for the RCT (DT in hospice patients) will be conducted according to the same design, by therapists-investigators in the year 2017, and continued for the consecutive

As in the pilot study, during the above-mentioned recruitment periods, the therapistsinvestigators will invite to take part in this trial, a larger number of patients with terminal cancer admitted to hospice care facility. Adult men and women (>18 years of age) with

posed of hospice patients and will receive a standard palliative care (PC) only.

with 4 bi-weekly sessions (the study intervention = Calendarium Vitae, CV).

will be enrolled into the study, which will be commenced in the year 2017.

study investigator or coordinator.

*4.2.5. Study groups*

DT intervention.

*hospice patients.*

steps of the project.

The patients in the SG will be obligated to:

• participation in the DT sessions; and

• filling out research questionnaires.

group.

All therapy sessions will be tape-recorded, transcribed, edited by the team and returned to the patient and the caregiver.

Construction and editing of the CV album requires a brief training session for the team members (to assure quality of care and to avoid bias)

Total duration of pilot study: 2 weeks (intervention) + 3 months follow-up.

Total duration of RCT: 2 weeks (intervention) + 6, 12 months follow-up.

Statistical analysis: descriptive statistics.

Equipment: laptops, dictaphones, paper, pens, pencils, graphic, and printing services.

#### **4.2. Detailed description of the study operationalization: logistics of the study**

#### *4.2.1. Setting*

This study will be conducted in Eastern and Central European hospice setting. Therapists (such as psychologists or physicians in collaboration with MS students, forming teams) who are interested and eligible to participate in the study and who are professionally involved with palliative care (PC) hospice settings will be invited to participate. It is estimated that the number of therapist-investigators should be approximately 2–4.

#### *4.2.2. Investigators*

Before initiation of the program, each team will receive an individual training with regard to the study design, procedures, and methodology, as described in the study protocol. In addition, every therapist-investigator will be trained in DT, in order to conduct the DT intervention.

#### *4.2.3. Participants*

Adult patients with terminal stage of cancer (<6 months prognosis) who are referred by their attending physicians (oncologists or family physicians) for palliative care (PC) hospice service and who express their interest in participation in the study will be invited as candidates, shortly after admission to hospice within the study recruitment period. The participants will be recruited from adult oncology patients, discharged from the University Hospitals or Oncology Centers.

#### *4.2.4. Recruitment*

Information about the study, together with an invitation to participate in it, will be conveyed to potential candidates, during routine hospice visits via flyers, posters, and also through advertisements in local newspapers, and via the Internet. Interested patients (and their caregivers) will receive detailed information regarding the DT course and will be screened (with the HADS). First-inclusion and exclusion criteria will be checked in a standardized interview, and then the patients (and the caregivers) will have a brief introduction conducted by the study investigator or coordinator.

It is estimated that the number of participants screened for the study should be approximately 100, in order to enroll into the study about 10–20 patients with terminal cancer, for the study group (SG), and about 10–20 patients, for the control group (CG). Eligible candidates will sign an ICF (after explanations about the study principles and voluntary participation in it) and will be enrolled into the study, which will be commenced in the year 2017.

#### *4.2.5. Study groups*

(each session could be extended to 2 hours, depending on the patient's condition)

Total duration of pilot study: 2 weeks (intervention) + 3 months follow-up.

Total duration of RCT: 2 weeks (intervention) + 6, 12 months follow-up.

number of therapist-investigators should be approximately 2–4.

volunteer (optional))

116 Clinical Trials in Vulnerable Populations

*4.2.1. Setting*

*4.2.2. Investigators*

*4.2.3. Participants*

Oncology Centers.

*4.2.4. Recruitment*

the patient and the caregiver.

bers (to assure quality of care and to avoid bias)

Statistical analysis: descriptive statistics.

All sessions will be conducted by a team, including a therapist (e.g., a psychologist, or a physician) and a student (a graduate student preparing MS thesis, or a specially trained hospice

All therapy sessions will be tape-recorded, transcribed, edited by the team and returned to

Construction and editing of the CV album requires a brief training session for the team mem-

Equipment: laptops, dictaphones, paper, pens, pencils, graphic, and printing services.

This study will be conducted in Eastern and Central European hospice setting. Therapists (such as psychologists or physicians in collaboration with MS students, forming teams) who are interested and eligible to participate in the study and who are professionally involved with palliative care (PC) hospice settings will be invited to participate. It is estimated that the

Before initiation of the program, each team will receive an individual training with regard to the study design, procedures, and methodology, as described in the study protocol. In addition, every therapist-investigator will be trained in DT, in order to conduct the DT intervention.

Adult patients with terminal stage of cancer (<6 months prognosis) who are referred by their attending physicians (oncologists or family physicians) for palliative care (PC) hospice service and who express their interest in participation in the study will be invited as candidates, shortly after admission to hospice within the study recruitment period. The participants will be recruited from adult oncology patients, discharged from the University Hospitals or

Information about the study, together with an invitation to participate in it, will be conveyed to potential candidates, during routine hospice visits via flyers, posters, and also through

**4.2. Detailed description of the study operationalization: logistics of the study**

In 2017, about 100 adult patients, who suffer from terminal cancer (diagnosed at least 3 months prior to entering of the pilot study) will be randomized to a study group or control group.

The study group (SG) (*N* = 10–20) will be composed of women and men with terminal cancer, with <6 months prognosis, aged >18 years, treated with a standard palliative care will receive DT intervention.

The control group (CG) (similar in size, age, diagnosis, and prognosis to the SG) will be composed of hospice patients and will receive a standard palliative care (PC) only.

Duration of the study DT intervention equals to 2 weeks, and includes: 2-week DT process, with 4 bi-weekly sessions (the study intervention = Calendarium Vitae, CV).

The patients in the SG will be obligated to:


The patients in the CG will be receiving PC only, and filling out research questionnaires.

The pilot study participants in both groups will continue their regular, standard PC.

#### *4.2.6. Management of randomized controlled trial (RCT) examining DT intervention among hospice patients.*

After completing of the pilot study, a subsequent step of recruitment of the volunteersparticipants for the RCT (DT in hospice patients) will be conducted according to the same design, by therapists-investigators in the year 2017, and continued for the consecutive steps of the project.

As in the pilot study, during the above-mentioned recruitment periods, the therapistsinvestigators will invite to take part in this trial, a larger number of patients with terminal cancer admitted to hospice care facility. Adult men and women (>18 years of age) with terminal cancer and <6 months prognosis, who are interested in participation in the trial will be given information about the study, upon admission to hospice, within the trial recruitment phase.

**8.** State of health prior to a diagnosis of cancer

tion of items 6–9) will be used as follows:

**5.** Place of residence (country, town)

ables in statistical analyses;

the study.

**2.** Date of birth (age)

**3.** Gender

**9.** Presence of serious/chronic diseases—what kind?

**4.** Education (higher, medium, or elementary level)

**6.** Type of the cancer of the relative admitted to hospice care

**9.** Presence of preexisting serious/chronic diseases—what kind?

from the statistical analyses will be made in the case of:

metric measurements obtained during the study visits.

**1.** lack of the complete answers in the questionnaire form;

**1.** The caregiver's identification number (for confidentiality purposes)

With regard to caregivers of the study patients, the analogical questionnaire (with modifica-

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**7.** Duration of to taking care of the relative with terminal cancer—how many years?

**8.** State of health prior to taking care of a relative with terminal cancer, admitted to hospice

The electronic database will be created using software program, and analyses of variables will be performed, utilizing the statistical program. Decisions regarding exclusion of the records

**2.** illegible or ambiguous record in the questionnaire, precluding proper evaluation of vari-

**4.** documented information of the therapist-investigator regarding further participation in

Psychometric measurements will be taken on the day of initial survey completion, and then post-DT intervention, and again, one 2 weeks after it. The study teams will collect the data using the study clinical report forms (CRF), based on the patients' questionnaires and psycho-

DT intervention (described in detail in another section) will be offered in one hospice center and will consists of a 1–2 hour sessions, 2 times per week (for 2 weeks), during which, the participants will complete the DT final document = CV album (including "life reflection interview" that will be transcribed and revised, before final edition of the CV album). The primary focus of the DT is to have a positive reflection on life, leading to decreased psychophysical distress and suffering that should translate into better QoL. Similarly, for the caregivers, the

**3.** lack of written signature of the study/trial participant (informed consent form); and

In the process of recruiting the hospice patients-volunteers to RCT (including distribution of the trial information and pre-screening via the standardized interview and HADS), the same methodology as in the pilot study will be used.

It is estimated that the number of participants screened for the RCT should be approximately 500, in order to enroll into the trial about 50–100 patients with terminal cancer for the study group (SG) and 50–100 patients with terminal cancer for the control group (CG).

Eligible candidates, who meet the Inclusion/exclusion criteria, will sign an ICF (after explanations about the trial principles, and voluntary participation in it), and will be enrolled into the trial, which will start in the year 2018. The trial will use the same procedures (including randomization), eligibility criteria, psychometric measurements, and outcome measures, as the pilot study. In 2019, a follow-up of this trial will be conducted using the same outcome measures as the ones used in the pilot study.

#### *4.2.7. Inclusion/exclusion criteria: (pilot study and trial (RCT))*

**Eligibility criteria:** Inclusion/exclusion for participants (as previously listed)

Based on:


patients who meet qualification criteria will be enrolled into the pilot study/RCT.

The data derived from the study participants will be summarized and then utilized in statistical analyses. Pilot study parameters, which will be analyzed, according to the questionnaire, prepared for the purpose of this study, will contain the following variables:


With regard to caregivers of the study patients, the analogical questionnaire (with modification of items 6–9) will be used as follows:


terminal cancer and <6 months prognosis, who are interested in participation in the trial will be given information about the study, upon admission to hospice, within the trial

In the process of recruiting the hospice patients-volunteers to RCT (including distribution of the trial information and pre-screening via the standardized interview and HADS), the same

It is estimated that the number of participants screened for the RCT should be approximately 500, in order to enroll into the trial about 50–100 patients with terminal cancer for the study

Eligible candidates, who meet the Inclusion/exclusion criteria, will sign an ICF (after explanations about the trial principles, and voluntary participation in it), and will be enrolled into the trial, which will start in the year 2018. The trial will use the same procedures (including randomization), eligibility criteria, psychometric measurements, and outcome measures, as the pilot study. In 2019, a follow-up of this trial will be conducted using the same outcome

group (SG) and 50–100 patients with terminal cancer for the control group (CG).

**Eligibility criteria:** Inclusion/exclusion for participants (as previously listed)

patients who meet qualification criteria will be enrolled into the pilot study/RCT.

prepared for the purpose of this study, will contain the following variables:

**1.** The participant's identification number (for confidentiality purposes)

The data derived from the study participants will be summarized and then utilized in statistical analyses. Pilot study parameters, which will be analyzed, according to the questionnaire,

recruitment phase.

118 Clinical Trials in Vulnerable Populations

Based on:

• screening interview,

**2.** Date of birth (age)

**6.** Type of the cancer

**3.** Gender

methodology as in the pilot study will be used.

measures as the ones used in the pilot study.

*4.2.7. Inclusion/exclusion criteria: (pilot study and trial (RCT))*

• meeting of the inclusion criteria (all the responses are Yes),

• signing a voluntary informed consent form (ICF),

**4.** Education (higher, medium, or elementary level)

**7.** Duration of the oncological therapy—how many years?

**5.** Place of residence (country, town)

• meeting of the exclusion criteria (all the responses are No), and


The electronic database will be created using software program, and analyses of variables will be performed, utilizing the statistical program. Decisions regarding exclusion of the records from the statistical analyses will be made in the case of:


Psychometric measurements will be taken on the day of initial survey completion, and then post-DT intervention, and again, one 2 weeks after it. The study teams will collect the data using the study clinical report forms (CRF), based on the patients' questionnaires and psychometric measurements obtained during the study visits.

DT intervention (described in detail in another section) will be offered in one hospice center and will consists of a 1–2 hour sessions, 2 times per week (for 2 weeks), during which, the participants will complete the DT final document = CV album (including "life reflection interview" that will be transcribed and revised, before final edition of the CV album). The primary focus of the DT is to have a positive reflection on life, leading to decreased psychophysical distress and suffering that should translate into better QoL. Similarly, for the caregivers, the main focus of the DT is to be able to better cope with stress and suffering, related to terminal disease of the relative.

Study discontinuation: The participants may withdraw from the study due to any reason,

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Limitations of the study: The interpretation of the results might be limited due to a small

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

Department of Family Practice, Medical University of Silesia (SUM), Katowice-Zabrze, Poland

[1] Chochinov HM. Health care, health caring, and the culture of medicine. Current Onco-

[2] Chochinov HM. The secret is out: Patients are people with feelings that matter. Palliative

[3] Corn BW, Chochinov HM, Vachon M. Integrating spiritual care into the practice of

[4] Sinclair S, Norris JM, McConnell SJ, Chochinov HM, Hack TF, Hagen NA, et al. Compassion: A scoping review of the healthcare literature. BMC Palliative Care. January 19,

[5] Sinclair S, McClement S, Raffin-Bouchal S, Hack TF, Hagen NA, McConnell S, Chochinov HM. Compassion in Health Care: An empirical model. Journal of Pain and Symptom

oncology. Current Opinion in Supportive and Palliative Care. 2012;**6**:226-227

to explore the DT intervention in research among hospice patients in this area.

without any consequences, and they will continue palliative care.

Conflict of interests: There is no conflict of interests.

Address all correspondence to: kasiaalpha@yahoo.co.uk

sample size.

**5. Conclusion**

**Author details**

Katarzyna Rygiel

**References**

logy. 2014 Oct;**21**(5):e668-9

Supportive Care. 2013;**11**:287-288

Management. 2016;**51**:193-203

2016;**15**:6. DOI: 10.1186/s12904-016-0080-0

#### *4.2.8. Study timeline*

Schedule of the research visits.

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

V# 2—Intake/interview (1 week),

V# 3—Revision/edition (2 weeks),

V# 4—Final (3 weeks).

Abbreviations used in the schedule: V—visit.

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 intervention benefits or possible concerns.

#### *4.2.9. Statistical analysis*

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 statistical program.

#### *4.2.10. Reference therapy*

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 to physical discomfort.

Safety, potential risk of the study: No risk/adverse effects to participants have been documented with regard to the DT intervention.

Study discontinuation: The participants may withdraw from the study due to any reason, without any consequences, and they will continue palliative care.

Limitations of the study: The interpretation of the results might be limited due to a small sample size.

Conflict of interests: There is no conflict of interests.
