Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06105359 |
| Other study ID # |
Necmettin Erbakan University1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 12, 2024 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Necmettin Erbakan University |
| Contact |
NESIBE GÜNAY MOLU |
| Phone |
05550163266 |
| Email |
nesibegunaymolu[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to determine the effect of dignity therapy on the quality of life
and depression levels of cancer patients.
Methods: The research was planned as a randomized controlled experimental study.
Type of Research: Research, experimental, control group and pretest-posttest study will be
carried out.
Population of the Study: The population of the study was sent to Meram Medical Faculty
Hospital Oncology Clinic consists of male and female inpatients.
Sample of the Research: Those who agreed to participate in the research and met the inclusion
criteria. Patients who meet will be included in the study. It was 48. It was planned to be.
Randomization: In this study, parallel group block randomization method was applied to the
intervention and control groups. will be allocated randomly. Block randomization was used
because the sample size was small. Patients will be selected equally using permutation
method, and randomization will be selected using blocking technique. will be done. During
randomization, CONSORT 2017 will be used.
For randomization; To control for performance bias, patients will be blinded to the study
hypothesis and will not be informed which group they are in. There will be no blinding for
the researcher. However, blind technique will be used in the research. This blind technique
will be applied by the researcher with the patients blinded until the application begins..
Data Collection Techniques and Tools: "Personal Information Form", "Patient Dignity
Inventory" and "Rosenberg Self-Esteem Scale" were used in data collection (RSES)" will be
used.
Description:
Cancer affects both the patient and their relatives physically and psychologically. From the
moment cancer is diagnosed, psychological problems that affect the adaptation processes of
individuals, which can be defined as crises, may arise along with the physical effects of the
disease and the treatment process. It is suggested that the loss of dignity that develops in
terminally ill patients causes the patients to want to die as soon as possible. It is
important that patients receive care in accordance with the standards and value judgments
they are used to, so that their sense of dignity and status is not affected by health
problems. Dignity therapy is a type of short-term therapy developed to alleviate the distress
of terminally ill patients and improve their end-of-life experiences. Chochinov emphasizes
that dignity depends on productivity experiences, the search for purpose and meaning, defined
dignity-protective care for patients facing a serious illness, and developed a model to be
developed, studied and used by clinicians.
In the literature, it is seen that dignity therapy can be applied by different health
professionals in patient groups with different diagnoses and provides positive contributions
for patients and their relatives. With the increase in palliative care units in recent years,
it has been considered important to apply this type of therapy to patients. In addition, no
studies on dignity therapy have been found in Turkey. The aim of this study is to determine
the effect of dignity therapy on the quality of life and depression levels of cancer
patients.
Methods: The research was planned as a randomized controlled experimental study. Research
Outpatient and inpatient treatment at Necmettin Erbakan University Faculty of Medicine
hospital oncology clinic It will be done with end-stage cancer patients. October
2023-December 2023 with an average of 48 patients It will be carried out between . In
collecting research data, Personal Information Form, Patient The Reputation Inventory and the
Rosenberg Self-Esteem Scale (RSES) will be used.
Type of Research: Research, experimental, control group and pretest-posttest study will be
carried out.
Place and Characteristics of the Research: The research was conducted in Konya province by
Necmettin Erbakan It will be carried out in the Oncology clinic of University Meram Faculty
of Medicine Hospital.Inpatient clinics are located on the 3rd and 4th floors, and there are
33 beds on each floor. Population of the Study: The population of the study was sent to Meram
Medical Faculty Hospital Oncology Clinic consists of male and female inpatients.
Sample of the Research: Those who agreed to participate in the research and met the inclusion
criteria. Patients who meet will be included in the study. The sample size in this study In
order to determine the results, a priori power analysis was performed with the G-Power 3.1
statistical program. In determining the sample size, "The effect of Chinese culture-adapted
dignity therapy on advanced cancer patients receiving chemotherapy in the Scores obtained
from the "day oncology unit: A quasi-experimental study" study were used. 95% confidence
(1-α), 80% test power (1-β), With an effect size of f = 0.78, the minimum number of samples
to be included in the study was determined as 44 in total, 22 in each group. Patients are
excluded from the study for many reasons. It was thought that there might be a loss of
approximately 10% due to separation, and the number of samples was 48. It was planned to be.
Randomization: In this study, parallel group block randomization method was applied to the
intervention and control groups. will be allocated randomly. Block randomization was used
because the sample size was small. Patients will be selected equally using permutation
method, and randomization will be selected using blocking technique. will be done. During
randomization, CONSORT 2017 (Randomized Parallel Group Updated Guidelines for Reporting
Research) will be used.
For randomization; To control for performance bias, patients will be blinded to the study
hypothesis and will not be informed which group they are in. There will be no blinding for
the researcher. However, blind technique will be used in the research. This blind technique
will be applied by the researcher with the patients blinded until the application begins. In
the research, in order to meet the blind technical conditions, the process steps were carried
out by an independent statistician from the first stage. The sample will be sorted by a
combination order and number. In this way selection bias will be controlled. The study will
also be controlled for attrition bias and Statistics and reporting bias.
Data Collection Techniques and Tools: "Personal Information Form (sociodemographic and
disease characteristics)", "Patient Dignity Inventory" and "Rosenberg Self-Esteem Scale" were
used in data collection (RSES)" will be used.
Data Collection Tools Personal Information Form: The form created by the researcher by
scanning the literature consists of 8 questions (age, gender, marital status, employment
status, monthly income level, education level, cancer type, how long ago it was diagnosed).
Patient Dignity Inventory: The scale, consisting of a total of 25 items, was developed by
Chochinov et al. (2008) and translated into Turkish by Eskigülek and Kav (2022) adapted. This
five-point Likert type inventory is rated as "1 = no problem, 2 = slight problem, 3 =
problem, 4 = big problem, 5 = very much problem." The minimum and maximum total score of the
inventory is 25 and 125 points respectively. There are no reverse scored items in the
inventory. A higher total score means that the individual's perceived reputation is complex.
Items scoring three or more are clinically meaningful. As a result of factor analysis, a
five-factor structure was obtained; The factors are reported as "symptom distress",
"existential distress", "addiction", "peace of mind" and "social support". The Cronbach alpha
value of the scale was reported as 0.94.
Rosenberg Self-Esteem Scale (RSES): The Rosenberg Self-Esteem Scale was developed by Morris
Rosenberg in 1965 to measure the self-esteem of adolescents (Rosenberg, 1965). Participants
score the questions as very true, true, false and very false. This scale, developed by
Rosenberg, consists of a total of 63 items and 12 subtests. Self-Esteem Scale, one of these
12 subtests, was used in this study. The scale consists of a total of 10 items, 5 negative
and 5 positive items. For questions 1, 2, 4, 6 and 7, respectively, it is very true (4), true
(3), wrong (2), very wrong (1). The opposite is true for articles 3, 5, 8, 9 and 10. A high
score on Rosenberg self-esteem means low self-esteem. A scale adaptation study was conducted
by Çuhadaroğlu in 1985. As a result of this study, the test-retest reliability of the scale
was found to be 0.75. The validity coefficient of the scale was found to be 0.71.
Application Steps: After the patients coming to the oncology clinic as outpatients or
inpatients are evaluated by their physicians, they will be referred to the researcher if the
predicted survival time is less than 6 months. The purpose of the study will be explained to
patients who meet the inclusion criteria, and for those who accept, planning will be made in
a way that will not disrupt the patient's treatment process, and the steps applied in dignity
therapy will be followed. Dignity therapy will be applied in the interview room that will be
requested in the oncology clinic to protect the confidentiality of information.
The application is planned as five sessions and the sessions will last approximately 40
minutes. Two questions in the dignity therapy protocol will be discussed in each session.
Dignity Therapy Necmettin Erbakan University Faculty of Nursing, Department of Mental Health
and Diseases Nursing. Lecturer It will be carried out by the researcher who serves as a
member. She has worked as a clinical nurse researcher and is an expert in psychiatric
nursing. Before the researcher started to apply this therapy, the 3-day "Dignity in Care -
Online Training 2023" (https://www.cpd-umanitoba.com/events/dignityin-care-online-training)
was held online between 14-28 September 2023. -2023/) attended the course. The course is
hosted by Harvey Max Chochinov, a Distinguished Professor of Psychiatry at the University of
Manitoba and Senior Scientist at the Cancer Care Manitoba Research Institute.
The therapist will interview each participant individually, it will be conducted in
accordance with the dignity therapy protocol, the interviews will be recorded with a voice
recorder, all recorded conversations will be transcribed and read to the patient after a
preliminary arrangement.
A discussion will be held on the areas that the patient wishes to change in the text, and as
included in the dignity therapy protocol, a session organization process will be carried out
with the participant, especially in the last session, in which the participant will be
provided with a written legacy (certificate of productivity). The Dignity therapist prepares
a document to be transferred to the participants' families, relatives or friends, with
patient approval. It will be made ready to be given after submission. The Dignity therapist
will create a written report at the end of the interviews to be given to their families and
present this report to the patients. The final version of the report will be given by the
patients.
Data Collection: Data will be collected by the researcher through face-to-face interviews in
the oncology clinic at Necmettin Erbakan University Faculty of Medicine Hospital, from
patients who meet the inclusion criteria and agree to participate in the study, without
disrupting the working order of the clinic. Data collection forms will be applied to both the
experimental and control groups as a pretest before dignity therapy begins to be applied to
the participants (in the 1st session) and as a posttest after dignity therapy is completed
(in the last session). Data collection tools will be filled in the patient room, respecting
the patient's privacy.
Research Variables Dependent variables: Patient Dignity Inventory, Rosenberg Self-Esteem
Scale Independent variables: Sociodemographic and disease characteristics, applied dignity
therapy Control variables: Age, gender Ethical Dimension of the Research: Permission for the
research was received from Necmettin Erbakan University Health Sciences Scientific Research
Ethics Committee and the Faculty of Medicine Hospital Oncology Clinic. Permission will be
obtained via e-mail from the authors of the scales to be used. Participants who will
participate in the research will be given verbal information about the research and Informed
Consent Form will be signed.
Participants who do not agree to participate in the research will not be forced to
participate. There is no conflict of interest between the researchers.
Statistical Evaluation of Data: Statistical analysis will be done using SPSS 23.0
(Statistical Package for Social Sciences Version 23.0) program. Cronbach's Alpha analysis
will be used in the internal consistency examination to determine the validity and
reliability of the scale, descriptive statistics will be used to determine the findings
regarding the individual characteristics of the participants, median and minimum/maximum
values for non-normally distributed variables, and mean±standard deviation values for
normally distributed variables. Appropriate statistical analyzes regarding the hypotheses
will be used to compare independent variables. The results obtained will be tested at the
p<0.05 significance level.
