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/NCT06025799</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00013620/8/2023</org_study_id>
      <nct_id>NCT06025799</nct_id>
    </id_info>
    <brief_title>Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer</brief_title>
    <official_title>Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer: A Randomized Control 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>
        Breast cancer is a significant issue in Egypt, affecting a large number of women and&#xD;
        impacting their psychological well-being. Younger patients and those undergoing adjuvant&#xD;
        therapy or radiotherapy are particularly susceptible to psychological distress. Psychological&#xD;
        counseling and support groups can help improve patients' quality of life and social&#xD;
        functioning. Hope plays a crucial role in the treatment process, as it is associated with&#xD;
        positive outcomes and serves as a protective mechanism against stress and disease.&#xD;
        Mindfulness-Based Stress Reduction (MBSR) is an intervention that can reduce stress and&#xD;
        depression in cancer patients. It involves cultivating awareness of the present moment and&#xD;
        has positive effects on quality of life. Investigating the impact of MBSR on psychological&#xD;
        distress and hope in women undergoing radiotherapy for breast cancer is important for&#xD;
        providing effective support during treatment.&#xD;
  &#xD;
        The aim of this study is to:&#xD;
  &#xD;
        Examine the effect of the Mindfulness-Based Stress reduction intervention on psychological&#xD;
        distress and hope among female patients undergoing radiotherapy for breast cancer.&#xD;
  &#xD;
        RESEARCH HYPOTHESIS Female patients undergoing radiotherapy for breast cancer who attend&#xD;
        Mindfulness-Based Stress reduction intervention sessions exhibit higher levels of hope and&#xD;
        lower levels of psychological distress compared to those who receive conventional hospital&#xD;
        treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Five Factors Mindfulness Questionnaire (FFMQ)</measure>
      <time_frame>5 weeks</time_frame>
      <description>The Baer et al. (2006) scale is a 39-item questionnaire designed to measure different aspects of mindfulness. It uses a five-point Likert scale, with responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.&#xD;
  Observing subscale: Measures the tendency to notice or attend to internal and external phenomena.&#xD;
  Describing subscale: Assesses the ability to label observed phenomena, such as thoughts and emotions.&#xD;
  Acting with awareness subscale: Reflects the extent to which individuals engage with full awareness in their current experience or activity.&#xD;
  Non-judging subscale: Assesses nonjudgmental awareness of current experience without evaluation.&#xD;
  Non-reactivity subscale: Measures the ability to notice internal phenomena without reacting to them.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression Anxiety and Stress Scale 21 (DASS-21)</measure>
      <time_frame>5 weeks</time_frame>
      <description>It is a self-reported scale developed by Lovibond, &amp; Lovibond, (1995). The three subscales of the DASS 21 measure the negative emotional states of depression, anxiety, and stress (i.e., nervous tension and irritability, which are factorially distinct from depression and anxiety). Participants scored questions such as &quot;I thought that as a person I wasn't worth much&quot; (from &quot;0&quot; =did not apply to me at all to &quot;3&quot; =applied very much to me or most of the time). A total score out of 21 was determined for each subscale and then multiplied by 2 to be equivalent to the full-scale DASS scores. At least 10 (depression), 8 (anxiety), and 15 (stress) ratings indicated psychological distress levels for each item. Distress severity was categorized as mild, moderate, severe, and very severe.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Herth Hope Index (HHI)</measure>
      <time_frame>5 weeks</time_frame>
      <description>The Herth Hope Index (HHI) is a clinical-setting adaptation form of the Herth Hope Scale (HHS). This scale was developed by Herth, at Minnesota State in the USA (Herth, 1992). It is composed of 12 items, which are rated on a four points Likert scale. The responses ranged from 1 (strongly disagree) to 4 (strongly agree). Items 3 and 6 are reversed in their score. The twelve items are summed to obtain a total score that ranges from 12 to 48, with a higher score equating to a higher level of hope. The instrument contains three factors, namely temporality &amp; future, positive readiness &amp; expectancy, and finally interconnectedness with self and others.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Breast Cancer Female</condition>
    <arm_group>
      <arm_group_label>&quot;Mindfulness-based stress reduction intervention&quot;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients who will be under routine hospital care as well as Mindfulness-Based Stress Reduction (MBSR) program The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot; routine hospital care&quot;</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Female cancer patients who will be under routine hospital care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness-based stress reduction intervention</intervention_name>
      <description>The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.</description>
      <arm_group_label>&quot;Mindfulness-based stress reduction intervention&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult female patients with post-mastectomy (within one to six months).&#xD;
  &#xD;
            -  Able to communicate verbally.&#xD;
  &#xD;
            -  Able to read and write.&#xD;
  &#xD;
            -  Willing to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  other associated diseases such as (renal disease, ischemic heart disease, liver&#xD;
               disease) will e excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Adult female patients with post-mastectomy to decrease the confounding factors.</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Nursing, Alexandria University</name>
        <address>
          <city>Alexandria</city>
          <zip>002</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <results_reference>
      <citation>Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.</citation>
      <PMID>11305069</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Heba Mohamed Abdelaal</investigator_full_name>
      <investigator_title>Assistant professor at Psychiatric&amp; Mental Health Nursing, Faculty of Nursing</investigator_title>
    </responsible_party>
    <keyword>Mindfulness-based stress reduction</keyword>
    <keyword>Psychological Distress</keyword>
    <keyword>Hope</keyword>
    <keyword>Female patients</keyword>
    <keyword>Radiotherapy</keyword>
    <keyword>Breast cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06025799
  org study id: IRB00013620/8/2023
  nct id: NCT06025799
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer is a significant issue in Egypt, affecting a large number of women and
        impacting their psychological well-being. Younger patients and those undergoing adjuvant
        therapy or radiotherapy are particularly susceptible to psychological distress. Psychological
        counseling and support groups can help improve patients' quality of life and social
        functioning. Hope plays a crucial role in the treatment process, as it is associated with
        positive outcomes and serves as a protective mechanism against stress and disease.
        Mindfulness-Based Stress Reduction (MBSR) is an intervention that can reduce stress and
        depression in cancer patients. It involves cultivating awareness of the present moment and
        has positive effects on quality of life. Investigating the impact of MBSR on psychological
        distress and hope in women undergoing radiotherapy for breast cancer is important for
        providing effective support during treatment.
  
        The aim of this study is to:
  
        Examine the effect of the Mindfulness-Based Stress reduction intervention on psychological
        distress and hope among female patients undergoing radiotherapy for breast cancer.
  
        RESEARCH HYPOTHESIS Female patients undergoing radiotherapy for breast cancer who attend
        Mindfulness-Based Stress reduction intervention sessions exhibit higher levels of hope and
        lower levels of psychological distress compared to those who receive conventional hospital
        treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Care Provider)
  measure: Five Factors Mindfulness Questionnaire (FFMQ)
  time frame: 5 weeks
  description: The Baer et al. (2006) scale is a 39-item questionnaire designed to measure different aspects of mindfulness. It uses a five-point Likert scale, with responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
  Observing subscale: Measures the tendency to notice or attend to internal and external phenomena.
  Describing subscale: Assesses the ability to label observed phenomena, such as thoughts and emotions.
  Acting with awareness subscale: Reflects the extent to which individuals engage with full awareness in their current experience or activity.
  Non-judging subscale: Assesses nonjudgmental awareness of current experience without evaluation.
  Non-reactivity subscale: Measures the ability to notice internal phenomena without reacting to them.
  measure: Depression Anxiety and Stress Scale 21 (DASS-21)
  time frame: 5 weeks
  description: It is a self-reported scale developed by Lovibond, & Lovibond, (1995). The three subscales of the DASS 21 measure the negative emotional states of depression, anxiety, and stress (i.e., nervous tension and irritability, which are factorially distinct from depression and anxiety). Participants scored questions such as "I thought that as a person I wasn't worth much" (from "0" =did not apply to me at all to "3" =applied very much to me or most of the time). A total score out of 21 was determined for each subscale and then multiplied by 2 to be equivalent to the full-scale DASS scores. At least 10 (depression), 8 (anxiety), and 15 (stress) ratings indicated psychological distress levels for each item. Distress severity was categorized as mild, moderate, severe, and very severe.
  measure: The Herth Hope Index (HHI)
  time frame: 5 weeks
  description: The Herth Hope Index (HHI) is a clinical-setting adaptation form of the Herth Hope Scale (HHS). This scale was developed by Herth, at Minnesota State in the USA (Herth, 1992). It is composed of 12 items, which are rated on a four points Likert scale. The responses ranged from 1 (strongly disagree) to 4 (strongly agree). Items 3 and 6 are reversed in their score. The twelve items are summed to obtain a total score that ranges from 12 to 48, with a higher score equating to a higher level of hope. The instrument contains three factors, namely temporality & future, positive readiness & expectancy, and finally interconnectedness with self and others.
  arm group label: "Mindfulness-based stress reduction intervention"
  arm group type: Experimental
  description: patients who will be under routine hospital care as well as Mindfulness-Based Stress Reduction (MBSR) program The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.
  arm group label: " routine hospital care"
  arm group type: No Intervention
  description: Female cancer patients who will be under routine hospital care
  intervention type: Behavioral
  intervention name: Mindfulness-based stress reduction intervention
  description: The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.
  arm group label: "Mindfulness-based stress reduction intervention"
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Adult female patients with post-mastectomy to decrease the confounding factors.
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Egypt
  citation: Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.
  PMID: 11305069
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Heba Mohamed Abdelaal
  investigator title: Assistant professor at Psychiatric& Mental Health Nursing, Faculty of Nursing
  mesh term: Breast Neoplasms
  sharing ipd: No