xml: <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/NCT05965596</url>
    </required_header>
    <id_info>
      <org_study_id>psycho-educational</org_study_id>
      <nct_id>NCT05965596</nct_id>
    </id_info>
    <brief_title>Effect of a Psycho-educational Intervention on Psychological Outcomes of Gynecological Cancer Patients</brief_title>
    <official_title>Effect of a Psycho-educational Intervention on Psychological Outcomes and Quality of Life Among Gynecological Cancer Patients in El-shatby University Hospital, Alexandria: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria 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>
        This study will be conducted to optimize the quality of care rendered for gynecological&#xD;
        cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in&#xD;
        Alexandria.As well as to assess the effect of implementing a psychoeducational intervention&#xD;
        program among gynecological cancer women on the:&#xD;
  &#xD;
          1. Quality of life with its different domains (physical, emotional, social and functional).&#xD;
             &quot;as a primary objective&quot;&#xD;
  &#xD;
          2. Psychological distress and cancer-specific stress. &quot;as secondary objectives&quot;&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cancer is a significant health problem worldwide with wide geographical variation in&#xD;
        incidence. Additionally it has become an important item in each country's health agenda.It is&#xD;
        a prominent cause of mortality in both economically developed and underdeveloped&#xD;
        nations.Unfortunately, the burden is expected to grow globally due to the development and&#xD;
        aging of the population.Gynecological cancer, which includes cancers of the cervix, ovary,&#xD;
        uterus, vulva, vagina and fallopian tube are among the leading causes of cancer-related&#xD;
        mortality worldwide.In Egypt, according to the Global Cancer Observatory (GLOBOCAN) 2020,&#xD;
        approximately 2,787 new cases for ovarian cancer were diagnosed and 1,839 women died from the&#xD;
        disease,1,694 new cases for uterine cancer and 350 women died from the disease and 1,320 new&#xD;
        cases for cervical cancer and 744 women died from the disease.&#xD;
  &#xD;
        Hence, this study will be carried out to develop and implement a psychoeducational&#xD;
        intervention program among gynecological cancer patients attending the Gynecological Oncology&#xD;
        Unit in El-Shatby University Hospital in Alexandria and evaluate its effect in improving&#xD;
        their psychological outcomes and quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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>a randomly selected sample of gynecological cancer women attending the study setting, fulfilling the inclusion criteria and consented to participate in the study will be recruited into the study sample. Then they will be randomly assigned into either the intervention group or the control group using computer-generated random codes in serially numbered opaque sealed envelopes. Creation and concealment of the allocation sequence will be done by the supervisor. While the researcher will enroll the participants, assess eligibility, discuss the trial, obtain consent, ascertain intervention assignment (such as opening next envelope) and carry out the intervention. Participants in the intervention group will receive a psycho educational intervention program and those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>A change in the Quality of life of gynecological cancer patients</measure>
      <time_frame>over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation</time_frame>
      <description>A change in the Quality of life from baseline and follow up sessions is assessed using the Arabic version of the Functional Assessment of Cancer Therapy-General (FACT-G) version 4. It includes 27 items and covers four primary QOL domains: physical wellbeing (PWB; 7 items, score range 0-28), emotional well-being (EWB; 6 items, score range 0-24), social well-being (SWB; 7 items, score range 0-28) and functional well-being (FWB; 7 items, score range 0-28). A five-point Likert scale will be used (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much), which provided four subscale scores and a total score ranging from 0 to 108, a higher score meaning a poor QOL, a lower score indicating high QOL and low effect of gynecological cancer treatment on QOL.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>A change in the Anxiety and depression</measure>
      <time_frame>over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation</time_frame>
      <description>A change in the psychological distress from baseline and follow up sessions is assessed using the Arabic version of the Hospital Anxiety and Depression Scale (HADS).There is a total of 14 items in the scale which are equally distributed into anxiety and depression subscales. Higher scores reflect greater psychological distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>A change in the Cancer-specific stress</measure>
      <time_frame>over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation</time_frame>
      <description>A change in the traumatic stress reactions to cancer diagnosis and treatment from baseline and follow up sessions is assessed using The Impact of Events Scale-Revised (ӀEЅ-R).The participants will be asked to rate the frequency of these feelings or events during the previous week, using а five-point Likert scale ranging from 0 = not at all to 4 = extremely. Items will be summed for а total score that ranges from 0 to 88. The IES-R is not meant to be diagnostic. While there is no specific cut-off score, scores higher than 24 are of concern; the higher the score the greater the concern for PTSD and associated health and well-being consequences.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Psychological</condition>
    <arm_group>
      <arm_group_label>the intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention group will receive a psychoeducational intervention program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>a psycho educational intervention program</intervention_name>
      <description>The program was developed by the researcher herself based on recommendations derived from a systematic review of psychoeducational interventions to improve the quality of Life and psychological outcomes in gynecological cancer patients. Also guided by the program adopted by chow et all in 2014(28) to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients.</description>
      <arm_group_label>the intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>the routine care</intervention_name>
      <description>the routine care provided for all gynecological cancer patients in the study setting</description>
      <arm_group_label>the control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Women are eligible to participate if they are:&#xD;
  &#xD;
            -  Over 20 years old.&#xD;
  &#xD;
            -  Newly diagnosed cases with gynecological cancers (confirmed within 3 months).&#xD;
  &#xD;
            -  Scheduled to have surgery as the first-line treatment.&#xD;
  &#xD;
            -  Willing to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Women are excluded if they:&#xD;
  &#xD;
            -  Are in the late stage (stage IV) as women in this group usually receive palliative/&#xD;
               symptomatic treatment.&#xD;
  &#xD;
            -  Have additional cancer diagnosis (including metastasis).&#xD;
  &#xD;
            -  Are diagnosed with severe psychiatric or cognitive disorder.&#xD;
  &#xD;
            -  Participate in other intervention study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>faculty of medicine Alexandria university</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fadia samir</last_name>
      <phone>01273855505</phone>
      <email>F_shaban2008@alexmed.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eman Darwish</last_name>
      <phone>01554967573</phone>
      <email>emandarwish09@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>El-Shatby University Hospital</name>
        <address>
          <city>Alexandria</city>
          <state>Bab Sharqi</state>
          <zip>21526</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Home / Hospitals / Alexandria / El Shatby Hospital</last_name>
        <phone>034861232</phone>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Chow KM, Chan JC, Choi KK, Chan CW. A Review of Psychoeducational Interventions to Improve Sexual Functioning, Quality of Life, and Psychological Outcomes in Gynecological Cancer Patients. Cancer Nurs. 2016 Jan-Feb;39(1):20-31. doi: 10.1097/NCC.0000000000000234.</citation>
      <PMID>25730595</PMID>
    </reference>
    <reference>
      <citation>Tangjitgamol S, Manusirivithaya S, Hanprasertpong J, Kasemsarn P, Soonthornthum T, Leelahakorn S, Thawaramara T, Lapcharoen O. Sexual dysfunction in Thai women with early-stage cervical cancer after radical hysterectomy. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):1104-12. doi: 10.1111/j.1525-1438.2007.00907.x. Epub 2007 Mar 15.</citation>
      <PMID>17367316</PMID>
    </reference>
    <reference>
      <citation>Padilla GV, Ferrell B, Grant MM, Rhiner M. Defining the content domain of quality of life for cancer patients with pain. Cancer Nurs. 1990 Apr;13(2):108-15.</citation>
      <PMID>2331691</PMID>
    </reference>
    <reference>
      <citation>Lim JW, Yi J, Zebrack B. Acculturation, social support, and quality of life for Korean immigrant breast and gynecological cancer survivors. Ethn Health. 2008 Jun;13(3):243-60. doi: 10.1080/13557850802009488.</citation>
      <PMID>18568975</PMID>
    </reference>
    <reference>
      <citation>Weaver KE, Forsythe LP, Reeve BB, Alfano CM, Rodriguez JL, Sabatino SA, Hawkins NA, Rowland JH. Mental and physical health-related quality of life among U.S. cancer survivors: population estimates from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Nov;21(11):2108-17. doi: 10.1158/1055-9965.EPI-12-0740. Epub 2012 Oct 30.</citation>
      <PMID>23112268</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>gynecological cancer</keyword>
    <keyword>quality of life</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965596
  org study id: psycho-educational
  nct id: NCT05965596
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will be conducted to optimize the quality of care rendered for gynecological
        cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in
        Alexandria.As well as to assess the effect of implementing a psychoeducational intervention
        program among gynecological cancer women on the:
  
          1. Quality of life with its different domains (physical, emotional, social and functional).
             "as a primary objective"
  
          2. Psychological distress and cancer-specific stress. "as secondary objectives"
  Cancer is a significant health problem worldwide with wide geographical variation in
        incidence. Additionally it has become an important item in each country's health agenda.It is
        a prominent cause of mortality in both economically developed and underdeveloped
        nations.Unfortunately, the burden is expected to grow globally due to the development and
        aging of the population.Gynecological cancer, which includes cancers of the cervix, ovary,
        uterus, vulva, vagina and fallopian tube are among the leading causes of cancer-related
        mortality worldwide.In Egypt, according to the Global Cancer Observatory (GLOBOCAN) 2020,
        approximately 2,787 new cases for ovarian cancer were diagnosed and 1,839 women died from the
        disease,1,694 new cases for uterine cancer and 350 women died from the disease and 1,320 new
        cases for cervical cancer and 744 women died from the disease.
  
        Hence, this study will be carried out to develop and implement a psychoeducational
        intervention program among gynecological cancer patients attending the Gynecological Oncology
        Unit in El-Shatby University Hospital in Alexandria and evaluate its effect in improving
        their psychological outcomes and quality of life.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: a randomly selected sample of gynecological cancer women attending the study setting, fulfilling the inclusion criteria and consented to participate in the study will be recruited into the study sample. Then they will be randomly assigned into either the intervention group or the control group using computer-generated random codes in serially numbered opaque sealed envelopes. Creation and concealment of the allocation sequence will be done by the supervisor. While the researcher will enroll the participants, assess eligibility, discuss the trial, obtain consent, ascertain intervention assignment (such as opening next envelope) and carry out the intervention. Participants in the intervention group will receive a psycho educational intervention program and those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: A change in the Quality of life of gynecological cancer patients
  time frame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
  description: A change in the Quality of life from baseline and follow up sessions is assessed using the Arabic version of the Functional Assessment of Cancer Therapy-General (FACT-G) version 4. It includes 27 items and covers four primary QOL domains: physical wellbeing (PWB; 7 items, score range 0-28), emotional well-being (EWB; 6 items, score range 0-24), social well-being (SWB; 7 items, score range 0-28) and functional well-being (FWB; 7 items, score range 0-28). A five-point Likert scale will be used (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much), which provided four subscale scores and a total score ranging from 0 to 108, a higher score meaning a poor QOL, a lower score indicating high QOL and low effect of gynecological cancer treatment on QOL.
  measure: A change in the Anxiety and depression
  time frame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
  description: A change in the psychological distress from baseline and follow up sessions is assessed using the Arabic version of the Hospital Anxiety and Depression Scale (HADS).There is a total of 14 items in the scale which are equally distributed into anxiety and depression subscales. Higher scores reflect greater psychological distress.
  measure: A change in the Cancer-specific stress
  time frame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
  description: A change in the traumatic stress reactions to cancer diagnosis and treatment from baseline and follow up sessions is assessed using The Impact of Events Scale-Revised (ӀEЅ-R).The participants will be asked to rate the frequency of these feelings or events during the previous week, using а five-point Likert scale ranging from 0 = not at all to 4 = extremely. Items will be summed for а total score that ranges from 0 to 88. The IES-R is not meant to be diagnostic. While there is no specific cut-off score, scores higher than 24 are of concern; the higher the score the greater the concern for PTSD and associated health and well-being consequences.
  arm group label: the intervention group
  arm group type: Experimental
  description: Participants in the intervention group will receive a psychoeducational intervention program
  arm group label: the control group
  arm group type: Sham Comparator
  description: those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.
  intervention type: Other
  intervention name: a psycho educational intervention program
  description: The program was developed by the researcher herself based on recommendations derived from a systematic review of psychoeducational interventions to improve the quality of Life and psychological outcomes in gynecological cancer patients. Also guided by the program adopted by chow et all in 2014(28) to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients.
  arm group label: the intervention group
  intervention type: Other
  intervention name: the routine care
  description: the routine care provided for all gynecological cancer patients in the study setting
  arm group label: the control group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: faculty of medicine Alexandria university
  role: Study Director
  affiliation: Alexandria University
  last name: Fadia samir
  phone: 01273855505
  email: F_shaban2008@alexmed.edu.eg
  last name: Eman Darwish
  phone: 01554967573
  email: emandarwish09@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Chow KM, Chan JC, Choi KK, Chan CW. A Review of Psychoeducational Interventions to Improve Sexual Functioning, Quality of Life, and Psychological Outcomes in Gynecological Cancer Patients. Cancer Nurs. 2016 Jan-Feb;39(1):20-31. doi: 10.1097/NCC.0000000000000234.
  PMID: 25730595
  citation: Tangjitgamol S, Manusirivithaya S, Hanprasertpong J, Kasemsarn P, Soonthornthum T, Leelahakorn S, Thawaramara T, Lapcharoen O. Sexual dysfunction in Thai women with early-stage cervical cancer after radical hysterectomy. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):1104-12. doi: 10.1111/j.1525-1438.2007.00907.x. Epub 2007 Mar 15.
  PMID: 17367316
  citation: Padilla GV, Ferrell B, Grant MM, Rhiner M. Defining the content domain of quality of life for cancer patients with pain. Cancer Nurs. 1990 Apr;13(2):108-15.
  PMID: 2331691
  citation: Lim JW, Yi J, Zebrack B. Acculturation, social support, and quality of life for Korean immigrant breast and gynecological cancer survivors. Ethn Health. 2008 Jun;13(3):243-60. doi: 10.1080/13557850802009488.
  PMID: 18568975
  citation: Weaver KE, Forsythe LP, Reeve BB, Alfano CM, Rodriguez JL, Sabatino SA, Hawkins NA, Rowland JH. Mental and physical health-related quality of life among U.S. cancer survivors: population estimates from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Nov;21(11):2108-17. doi: 10.1158/1055-9965.EPI-12-0740. Epub 2012 Oct 30.
  PMID: 23112268
  responsible party type: Sponsor