<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415411</url>
  </required_header>
  <id_info>
    <org_study_id>Interventional</org_study_id>
    <secondary_id>PYO. SBF.1904.19.006</secondary_id>
    <nct_id>NCT04415411</nct_id>
  </id_info>
  <brief_title>Effects of Nursing Care Provided to Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope</brief_title>
  <official_title>Effects of Nursing Care Provided to the Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ondokuz Mayıs University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ondokuz Mayıs University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the effects of nursing care provided based on the&#xD;
      Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers'&#xD;
      spiritual well-being and hope. This research was conducted with 60 patient relatives&#xD;
      (intervention group: 30, control group: 30) taking care of their patient in palliative care&#xD;
      unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Every year, millions of patients as well as millions of patients are primarily involved in&#xD;
      the palliative care process. It is emphasized that from the very start of palliative care&#xD;
      process until grievance stage, patient relatives require a myriad of physical, psychological,&#xD;
      social and spiritual needs. It has been widely reported that among relatives of palliative&#xD;
      care patients, there is a high incidence of mental distress, depression, anxiety, sleep&#xD;
      disturbance, fear and despair. The maintain of hope and spiritual well-being are important in&#xD;
      dealing with this difficult process. Accordingly, nursing care is important, which supports&#xD;
      the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and&#xD;
      focuses on spiritual dimensions is important in Watson's Human Care Theory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In this study, there are two groups as intervention group and control group. Investigator, administered not any application to control group. Nursing care which based on the Theory of Human Caring was given to intervention group for 4 weeks.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Due to the nature of the research, it was not possible to blind the participants to group assignment. Additionally, due to the study being conducted for a doctoral thesis, data collection (pre and posttest), interviews, interventions and evaluation of data carried out by the same researcher who was not blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hopeless level of patient relatives</measure>
    <time_frame>1. week</time_frame>
    <description>Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spiritual well-being level of patient relatives</measure>
    <time_frame>1. week</time_frame>
    <description>Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Hope</condition>
  <condition>Spirituality</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine nursing care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nursing care based on the Theory of Human Caring</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nursing care based on the Theory of Human Caring</intervention_name>
    <description>Planned nursing care based on 10 caritas processes of Theory of Human Caring.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 and above&#xD;
&#xD;
          -  willingness and motivation to participate in research&#xD;
&#xD;
          -  literacy&#xD;
&#xD;
          -  being the primary caregiver&#xD;
&#xD;
          -  lack of mental or verbal deficiency to respond the questions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aged 18 below&#xD;
&#xD;
          -  unwilling to participate in research&#xD;
&#xD;
          -  illiterate&#xD;
&#xD;
          -  non-primary caregiver&#xD;
&#xD;
          -  mental or communicative disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aslı Kurtgöz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amasya University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zeliha Koc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ondokuz Mayıs University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ondokuz Mayıs University</name>
      <address>
        <city>Samsun</city>
        <zip>55312</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.who.int/health-topics/palliative-care</url>
    <description>WHO (2019). Palliative care</description>
  </link>
  <link>
    <url>http://www.virtualhospice.ca/Assets/PEOLC_Report_EN(1)_20170605131142.pdf</url>
    <description>Canadian Cancer Research Alliance (2017). Pan-canadian framework for palliative and end-of life care research</description>
  </link>
  <link>
    <url>http://www.watsoncaringscience.org/files/PDF/watsons-theory-of-human-caring-core-concepts-and-evolution-to-caritas-processes-handout.pdf</url>
    <description>Watson, J. (2010). Core concepts of Jean Watson's Theory of human caring/caring science.</description>
  </link>
  <reference>
    <citation>De Korte-Verhoef MC, Pasman HR, Schweitzer BP, Francke AL, Onwuteaka-Philipsen BD, Deliens L. Burden for family carers at the end of life; a mixed-method study of the perspectives of family carers and GPs. BMC Palliat Care. 2014 Mar 31;13(1):16. doi: 10.1186/1472-684X-13-16.</citation>
    <PMID>24678941</PMID>
  </reference>
  <reference>
    <citation>Gotze H, Brahler E, Gansera L, Polze N, Kohler N. Psychological distress and quality of life of palliative cancer patients and their caring relatives during home care. Support Care Cancer. 2014 Oct;22(10):2775-82. doi: 10.1007/s00520-014-2257-5. Epub 2014 May 9.</citation>
    <PMID>24811216</PMID>
  </reference>
  <reference>
    <citation>Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.</citation>
    <PMID>28486962</PMID>
  </reference>
  <reference>
    <citation>Oechsle K, Ullrich A, Marx G, Benze G, Heine J, Dickel LM, Zhang Y, Wowretzko F, Wendt KN, Nauck F, Bokemeyer C, Bergelt C. Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care. BMC Palliat Care. 2019 Nov 18;18(1):102. doi: 10.1186/s12904-019-0469-7.</citation>
    <PMID>31739802</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
    <investigator_full_name>Asli Kurtgöz</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>family members</keyword>
  <keyword>hope</keyword>
  <keyword>nursing care</keyword>
  <keyword>palliative care</keyword>
  <keyword>spirituality</keyword>
  <keyword>relatives</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There are no plans</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415411
org study id: Interventional
secondary id: PYO. SBF.1904.19.006
nct id: NCT04415411
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the effects of nursing care provided based on the
      Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers'
      spiritual well-being and hope. This research was conducted with 60 patient relatives
      (intervention group: 30, control group: 30) taking care of their patient in palliative care
      unit.
Every year, millions of patients as well as millions of patients are primarily involved in
      the palliative care process. It is emphasized that from the very start of palliative care
      process until grievance stage, patient relatives require a myriad of physical, psychological,
      social and spiritual needs. It has been widely reported that among relatives of palliative
      care patients, there is a high incidence of mental distress, depression, anxiety, sleep
      disturbance, fear and despair. The maintain of hope and spiritual well-being are important in
      dealing with this difficult process. Accordingly, nursing care is important, which supports
      the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and
      focuses on spiritual dimensions is important in Watson's Human Care Theory.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, there are two groups as intervention group and control group. Investigator, administered not any application to control group. Nursing care which based on the Theory of Human Caring was given to intervention group for 4 weeks.
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Due to the nature of the research, it was not possible to blind the participants to group assignment. Additionally, due to the study being conducted for a doctoral thesis, data collection (pre and posttest), interviews, interventions and evaluation of data carried out by the same researcher who was not blinded.
measure: Hopeless level of patient relatives
time frame: 1. week
description: Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.
measure: Spiritual well-being level of patient relatives
time frame: 1. week
description: Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.
measure: Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)
time frame: 4 weeks
description: Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual.
measure: Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)
time frame: 4 weeks
description: Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being.
arm group label: Control group
arm group type: No Intervention
description: Routine nursing care
arm group label: Intervention group
arm group type: Experimental
description: Nursing care based on the Theory of Human Caring
intervention type: Other
intervention name: Nursing care based on the Theory of Human Caring
description: Planned nursing care based on 10 caritas processes of Theory of Human Caring.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aslı Kurtgöz, PhD
role: Principal Investigator
affiliation: Amasya University
last name: Zeliha Koc, PhD
role: Principal Investigator
affiliation: Ondokuz Mayıs University
facility: 
country: Turkey
url: http://www.who.int/health-topics/palliative-care
description: WHO (2019). Palliative care
url: http://www.virtualhospice.ca/Assets/PEOLC_Report_EN(1)_20170605131142.pdf
description: Canadian Cancer Research Alliance (2017). Pan-canadian framework for palliative and end-of life care research
url: http://www.watsoncaringscience.org/files/PDF/watsons-theory-of-human-caring-core-concepts-and-evolution-to-caritas-processes-handout.pdf
description: Watson, J. (2010). Core concepts of Jean Watson's Theory of human caring/caring science.
citation: De Korte-Verhoef MC, Pasman HR, Schweitzer BP, Francke AL, Onwuteaka-Philipsen BD, Deliens L. Burden for family carers at the end of life; a mixed-method study of the perspectives of family carers and GPs. BMC Palliat Care. 2014 Mar 31;13(1):16. doi: 10.1186/1472-684X-13-16.
PMID: 24678941
citation: Gotze H, Brahler E, Gansera L, Polze N, Kohler N. Psychological distress and quality of life of palliative cancer patients and their caring relatives during home care. Support Care Cancer. 2014 Oct;22(10):2775-82. doi: 10.1007/s00520-014-2257-5. Epub 2014 May 9.
PMID: 24811216
citation: Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.
PMID: 28486962
citation: Oechsle K, Ullrich A, Marx G, Benze G, Heine J, Dickel LM, Zhang Y, Wowretzko F, Wendt KN, Nauck F, Bokemeyer C, Bergelt C. Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care. BMC Palliat Care. 2019 Nov 18;18(1):102. doi: 10.1186/s12904-019-0469-7.
PMID: 31739802
responsible party type: Principal Investigator
investigator affiliation: Ondokuz Mayıs University
investigator full name: Asli Kurtgöz
investigator title: PhD
sharing ipd: No
ipd description: There are no plans