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/NCT05963412</url>
    </required_header>
    <id_info>
      <org_study_id>MeaningInt-BreastCancer</org_study_id>
      <nct_id>NCT05963412</nct_id>
    </id_info>
    <brief_title>Online Individual Intervention Program to Make Sense of People's Experiences After a Breast Cancer Diagnosis</brief_title>
    <official_title>Developing an Online Individual Intervention Program to Make Sense of People's Experiences After a Breast Cancer Diagnosis and Examining Its Effectiveness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dokuz Eylul University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dokuz Eylul University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The unexpected changes caused by the diagnosis and treatment of breast cancer can lead&#xD;
        individuals to question their beliefs, life meanings, and goals, prompting a search for&#xD;
        meaning. According to Park and Folkman's (1997) Meaning-Making Model, the process of meaning&#xD;
        making functions as a coping mechanism. It helps individuals adapt challenging experiences&#xD;
        into their lives, ultimately assisting in their psychological adjustment to stressful&#xD;
        situations. Based on this theoretical model, principles from meaning therapy (Wong, 2010),&#xD;
        literature reviews, interviews with breast cancer patients, and expert consultation, an&#xD;
        8-week online individual psychological intervention was developed. It was aimed at&#xD;
        facilitating the finding of new meanings in the experience of breast cancer and promoting&#xD;
        psychological well-being. It includes psycho-educational, cognitive, existential, and&#xD;
        behavioral components explicitly focusing on the meaning-making process. This intervention is&#xD;
        called the Meaning Centered Coping Program (MCCP). The main purpose of this study was to test&#xD;
        whether the MCCP was an effective intervention program for women diagnosed with breast&#xD;
        cancer. For this purpose, the study sample consisted of women with stage I, II, and III&#xD;
        breast cancer. Then, participants were randomly assigned to the MCCP group and the wait-list&#xD;
        control group. A number of reliable and valid measurement tools were used to compare the MCCP&#xD;
        group with the waitlist control group and to examine the effect of the program. Compared with&#xD;
        the control group, significant improvements were expected in the level of meaning in life,&#xD;
        post-traumatic growth, situational meanings, psychological inflexibility, and psychological&#xD;
        well-being in the MCCP group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In recent years, there has been a growing discussion about the necessity for mental health&#xD;
        services not only to alleviate individuals' psychological distress but also to focus on&#xD;
        enhancing the sense of meaning in life. Therefore, the MCCP aimed not only to reduce&#xD;
        distressing psychological symptoms but also to facilitate the discovery of new positive&#xD;
        meanings in breast cancer and individual's life, despite existing limitations. In this&#xD;
        regard, the MCCP has been developed by drawing upon Meaning-Making Model (Park, 2010; Park&#xD;
        and Folkman,1997), principles of meaning therapy (Wong, 2010), the literature on meaning, and&#xD;
        existing meaning centered psychotherapy approaches. Additionally, considering limitations&#xD;
        such as potential program changes, transportation difficulties, and inadequate physical&#xD;
        conditions, online interventions offer a reliable alternative that provides numerous&#xD;
        advantages for individuals diagnosed with breast cancer. Therefore, the intervention program&#xD;
        was implemented online via video conference for women diagnosed with breast cancer in the&#xD;
        current study. After the program was developed, a pilot study was conducted. According to the&#xD;
        expert's feedback, the final version of MCCP was developed. The primary aim was to test the&#xD;
        effectiveness of MCCP among women with breast cancer. The research hypotheses are 1) compared&#xD;
        to control grup, MCCP group would show better improvement in meaning in life and PTG scores&#xD;
        2) compared to control grup, MCCP group would show better improvements in situational meaning&#xD;
        (i.e. stress appraisal and violations in general meaning) 3) Compared to control group, the&#xD;
        MCCP group would report significant decrease in automatic meaning making efforts (i.e.&#xD;
        intrusion and avoidance) 4) Compared to control group, the MCCP group would report a&#xD;
        significantly higher level of psychological flexibility and lower level of psychological&#xD;
        distress.&#xD;
  &#xD;
        Before the data collection process, ethical approval was obtained from the Institutional&#xD;
        Ethics Committee of Dokuz Eylül University, affiliated with Dokuz Eylül University School of&#xD;
        Medicine (Ethics Committee Decision No: 2021/12-39). The study has been announced using&#xD;
        social media platforms (Facebook, Twitter, Instagram), oncology associations established to&#xD;
        support oncology patients, and referrals from healthcare professionals to reach potential&#xD;
        participants. The sample size was determined using the power analysis method. Then, 44 women&#xD;
        diagnosed with breast cancer who volunteered to participate in the study were randomly&#xD;
        assigned to either the intervention group or the waitlist control group.&#xD;
  &#xD;
        The random assignment process was conducted using the website https://www.randomizer.org/.&#xD;
        Participants in the MCCP group were assessed thrice: before the intervention, immediately&#xD;
        after the intervention, and at the 2-month follow-up. The control group underwent the initial&#xD;
        assessment before intervention began and the final assessment took place eight weeks later.&#xD;
        After getting verbal and written consent from all participants, a number of measurement tools&#xD;
        was applied. The Sociodemographic and Disease-Related Information Form, The Meaning in Life&#xD;
        Questionnaire, Posttraumatic Growth Inventory-X, Stress Appraisal Measure, Global Meaning&#xD;
        Violations Scale, Impact of Event Scale-Revised Form, Acceptance and Action Scale-II, and&#xD;
        Hospital Anxiety and Depression Scale were used. To test the hypotheses of the study, Pearson&#xD;
        correlation analysis, 2 (Group) X 2 (Time) repeated measures ANOVA, and one-way repeated&#xD;
        measures ANOVA were applied. SPSS 29.0 Package Program for Social Sciences was used for&#xD;
        statistical analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 30, 2021</start_date>
    <completion_date type="Actual">December 30, 2022</completion_date>
    <primary_completion_date type="Actual">October 30, 2022</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Socio-demographic and Disease-Related Information Form</measure>
      <time_frame>Baseline (before the intervention program begins)</time_frame>
      <description>This form is a questionnaire designed to gather socio-demographic characteristics and information related to the diagnosis of breast cancer from the participants. Socio-demographic questions include the participant's age, educational level, occupation, income level, marital status, the number of children, and health insurance coverage. The questions related to breast cancer include the time since diagnosis, clinical stage of breast cancer, duration of treatment, completed treatment, type of surgical interventions, cancer history and menstrual status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the Meaning in Life Questionnaire</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up</time_frame>
      <description>The Meaning in Life Scale was developed to measure individuals' level of meaning and purpose in life (Steger et al., 2006) The scale consists of a total of ten items and comprises two dimensions: the presence of meaning and the search for meaning. The scale is assessed using a 7 point scale scored from 1 to 7. The Turkish version of The Meaning in Life Questionnaire, adapted by Akin and Taş (2015), was used in this study. Psychometric features of the Turkish version of the scale indicated that it was a valid and reliable measurement tool.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Post-traumatic Growth Inventory-X</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.</time_frame>
      <description>The Posttraumatic Growth Inventory (PTGI) is developed to assess positive changes experienced following traumatic life events. In this study, the Posttraumatic Growth Inventory-X (PTGI-X) was used (Tedeschi et al., 2017). The inventory consists of 25 items and is scored on a six-point scale scored from 0 to 5. Higher scores on the inventory indicated higher levels of posttraumatic growth. The Psychometric properties of the inventory are sufficient to measure the level of post-traumatic growth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in The Stress Appraisal Measure</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.</time_frame>
      <description>The scale developed by Peacock and Wong (1990) is designed to assess the cognitive evaluation of stress. It consists of 24 items. The items are evaluated using a likert scale scored from 1 to 5. The scale comprises five subscales that involve primary (threat and challenge) and secondary appraisals (uncontrollable-by-anyone, controllable-by-self, and controllable-by-others). The scale is recommended by Park and George (2013) for assessing situational meaning. The Turkish version of the scale was used for this purpose in the current study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Global Meaning Violation Scale</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.</time_frame>
      <description>The scale developed by Park and colleagues (2016) is designed to assess disruptions in global meaning following a traumatic or stressful life event. It consists of 13 items. Each item of the scale is evaluated using a five-point scale scored from 1 to 5. Psychometric results demonstrated that the Turkish version of the scale was valid and reliable (Acet et al., 2020).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in The Impact of Event Scale-Revised</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.</time_frame>
      <description>The scale was developed to assess traumatic stress symptoms (Weiss,2004). It consists of 22 items, which are evaluated using a Likert scale scored from 0 to 4. The scale comprises three subscales. These are intrusion, avoidance, and hyperarousal . The adaptation of the scale to Turkish was conducted by Çorapçıoğlu and colleagues (2006). Within the scope of the current study, intrusions and avoidance were used to assess automatic meaning-making efforts.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Acceptance and Action Questionnaire-II</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.</time_frame>
      <description>The Acceptance and Action Questionnaire-II (AAQ-II) was developed to measure psychological inflexibility/flexibility (Bond et al., 2011). The scale consists of a total of seven items, each of which is rated on a seven-point scale scored from 1 to 7. Higher scores on the scale indicate higher levels of psychological inflexibility. The scale has been adapted into Turkish by Meunier and colleagues (2014).Turkish version of the scale demonstrated adequate psychometric properties.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in The Hospital Anxiety and Depression Scale</measure>
      <time_frame>Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.</time_frame>
      <description>The scale was developed by Zigmond and Snaith (1983) to assess the levels of depression and anxiety in individuals diagnosed with various physical illnesses. The scale consists of a total of 14 items, with seven items evaluating anxiety and another seven items assessing depression levels. Participants are asked to rate each item on a four-point scale ranging from 0 to 3. The Turkish validity and reliability study of the Hospital Anxiety and Depression Scale (HADS) was conducted by Aydemir and colleagues (1997). The HADS is a valid and reliable measurement tool for assessing anxiety and depression levels in samples with a medical diagnosis.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">44</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Online Individual Intervention Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The online intervention program (namely, Meaning-Centered Coping Program) consists of eight individual sessions, each lasting approximately 60 min. Sessions were conducted per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Intervention: Waitlist Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A wait-list control group was used. Participants assigned to the wait-list control group did not receive the intervention immediately. After the final assessment was administered (eight weeks later since the initial assessment), they were able to participate in the same intervention program if they wanted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Meaning Centered Coping Program</intervention_name>
      <description>Meaning Centered Coping Program is a psychological intervention program developed for women diagnosed with breast cancer, based on the Meaning Making Model (Park, 2010; Park and Folkman, 1997) and Wong's (2010) principles of Meaning Therapy. Each weekly session had specific topics. These are:&#xD;
  Session 1: Guiding patients to tell the story of their breast cancer and psycho-education; Session 2: Encouraging patients to talk about the effects of breast cancer on their lives and learning to accept their difficult emotions; Session 3: Focusing on cognition through the meaning attributed to breast cancer; Session 4: Learning to take alternative perspectives and defusing their negative thoughts; Session 5: Exploring personal strengths; Session 6: İdentifying important life values and moving toward value-based actions; Session 7: Finding meaning in breast cancer and life; Session 8: Focusing on Future plans and hopes</description>
      <arm_group_label>Online Individual Intervention Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          i) being between the ages of 18-65 ii) being a woman iii) stage I, II, and III patients iv)&#xD;
          having been diagnosed for at least 6 months and at most 3 years v) being able to&#xD;
          video-conference using a desktop computer, a laptop, or a tablet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          i) not having any psychiatric diagnosis or currently using psychiatric medication, ii) not&#xD;
          currently receiving psychological support, iii) having a history of cancer diagnosis iv)&#xD;
          having a diagnosis of advanced stage (Stage IV) breast cancer.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The study included women diagnosed with breast cancer. In this regard, biological sex was considered.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Selva Ülbe</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dokuz Eylul University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dokuz Eylul University, Faculty of Letters</name>
        <address>
          <city>İzmir</city>
          <zip>35390</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 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 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
      <investigator_full_name>Selva Ülbe</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>meaning making</keyword>
    <keyword>online intervention program</keyword>
    <keyword>psychological health</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/NCT05963412
  org study id: MeaningInt-BreastCancer
  nct id: NCT05963412
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The unexpected changes caused by the diagnosis and treatment of breast cancer can lead
        individuals to question their beliefs, life meanings, and goals, prompting a search for
        meaning. According to Park and Folkman's (1997) Meaning-Making Model, the process of meaning
        making functions as a coping mechanism. It helps individuals adapt challenging experiences
        into their lives, ultimately assisting in their psychological adjustment to stressful
        situations. Based on this theoretical model, principles from meaning therapy (Wong, 2010),
        literature reviews, interviews with breast cancer patients, and expert consultation, an
        8-week online individual psychological intervention was developed. It was aimed at
        facilitating the finding of new meanings in the experience of breast cancer and promoting
        psychological well-being. It includes psycho-educational, cognitive, existential, and
        behavioral components explicitly focusing on the meaning-making process. This intervention is
        called the Meaning Centered Coping Program (MCCP). The main purpose of this study was to test
        whether the MCCP was an effective intervention program for women diagnosed with breast
        cancer. For this purpose, the study sample consisted of women with stage I, II, and III
        breast cancer. Then, participants were randomly assigned to the MCCP group and the wait-list
        control group. A number of reliable and valid measurement tools were used to compare the MCCP
        group with the waitlist control group and to examine the effect of the program. Compared with
        the control group, significant improvements were expected in the level of meaning in life,
        post-traumatic growth, situational meanings, psychological inflexibility, and psychological
        well-being in the MCCP group.
  In recent years, there has been a growing discussion about the necessity for mental health
        services not only to alleviate individuals' psychological distress but also to focus on
        enhancing the sense of meaning in life. Therefore, the MCCP aimed not only to reduce
        distressing psychological symptoms but also to facilitate the discovery of new positive
        meanings in breast cancer and individual's life, despite existing limitations. In this
        regard, the MCCP has been developed by drawing upon Meaning-Making Model (Park, 2010; Park
        and Folkman,1997), principles of meaning therapy (Wong, 2010), the literature on meaning, and
        existing meaning centered psychotherapy approaches. Additionally, considering limitations
        such as potential program changes, transportation difficulties, and inadequate physical
        conditions, online interventions offer a reliable alternative that provides numerous
        advantages for individuals diagnosed with breast cancer. Therefore, the intervention program
        was implemented online via video conference for women diagnosed with breast cancer in the
        current study. After the program was developed, a pilot study was conducted. According to the
        expert's feedback, the final version of MCCP was developed. The primary aim was to test the
        effectiveness of MCCP among women with breast cancer. The research hypotheses are 1) compared
        to control grup, MCCP group would show better improvement in meaning in life and PTG scores
        2) compared to control grup, MCCP group would show better improvements in situational meaning
        (i.e. stress appraisal and violations in general meaning) 3) Compared to control group, the
        MCCP group would report significant decrease in automatic meaning making efforts (i.e.
        intrusion and avoidance) 4) Compared to control group, the MCCP group would report a
        significantly higher level of psychological flexibility and lower level of psychological
        distress.
  
        Before the data collection process, ethical approval was obtained from the Institutional
        Ethics Committee of Dokuz Eylül University, affiliated with Dokuz Eylül University School of
        Medicine (Ethics Committee Decision No: 2021/12-39). The study has been announced using
        social media platforms (Facebook, Twitter, Instagram), oncology associations established to
        support oncology patients, and referrals from healthcare professionals to reach potential
        participants. The sample size was determined using the power analysis method. Then, 44 women
        diagnosed with breast cancer who volunteered to participate in the study were randomly
        assigned to either the intervention group or the waitlist control group.
  
        The random assignment process was conducted using the website https://www.randomizer.org/.
        Participants in the MCCP group were assessed thrice: before the intervention, immediately
        after the intervention, and at the 2-month follow-up. The control group underwent the initial
        assessment before intervention began and the final assessment took place eight weeks later.
        After getting verbal and written consent from all participants, a number of measurement tools
        was applied. The Sociodemographic and Disease-Related Information Form, The Meaning in Life
        Questionnaire, Posttraumatic Growth Inventory-X, Stress Appraisal Measure, Global Meaning
        Violations Scale, Impact of Event Scale-Revised Form, Acceptance and Action Scale-II, and
        Hospital Anxiety and Depression Scale were used. To test the hypotheses of the study, Pearson
        correlation analysis, 2 (Group) X 2 (Time) repeated measures ANOVA, and one-way repeated
        measures ANOVA were applied. SPSS 29.0 Package Program for Social Sciences was used for
        statistical analyses.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Socio-demographic and Disease-Related Information Form
  time frame: Baseline (before the intervention program begins)
  description: This form is a questionnaire designed to gather socio-demographic characteristics and information related to the diagnosis of breast cancer from the participants. Socio-demographic questions include the participant's age, educational level, occupation, income level, marital status, the number of children, and health insurance coverage. The questions related to breast cancer include the time since diagnosis, clinical stage of breast cancer, duration of treatment, completed treatment, type of surgical interventions, cancer history and menstrual status.
  measure: Change in the Meaning in Life Questionnaire
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up
  description: The Meaning in Life Scale was developed to measure individuals' level of meaning and purpose in life (Steger et al., 2006) The scale consists of a total of ten items and comprises two dimensions: the presence of meaning and the search for meaning. The scale is assessed using a 7 point scale scored from 1 to 7. The Turkish version of The Meaning in Life Questionnaire, adapted by Akin and Taş (2015), was used in this study. Psychometric features of the Turkish version of the scale indicated that it was a valid and reliable measurement tool.
  measure: Change in Post-traumatic Growth Inventory-X
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
  description: The Posttraumatic Growth Inventory (PTGI) is developed to assess positive changes experienced following traumatic life events. In this study, the Posttraumatic Growth Inventory-X (PTGI-X) was used (Tedeschi et al., 2017). The inventory consists of 25 items and is scored on a six-point scale scored from 0 to 5. Higher scores on the inventory indicated higher levels of posttraumatic growth. The Psychometric properties of the inventory are sufficient to measure the level of post-traumatic growth.
  measure: Change in The Stress Appraisal Measure
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
  description: The scale developed by Peacock and Wong (1990) is designed to assess the cognitive evaluation of stress. It consists of 24 items. The items are evaluated using a likert scale scored from 1 to 5. The scale comprises five subscales that involve primary (threat and challenge) and secondary appraisals (uncontrollable-by-anyone, controllable-by-self, and controllable-by-others). The scale is recommended by Park and George (2013) for assessing situational meaning. The Turkish version of the scale was used for this purpose in the current study.
  measure: Change in Global Meaning Violation Scale
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
  description: The scale developed by Park and colleagues (2016) is designed to assess disruptions in global meaning following a traumatic or stressful life event. It consists of 13 items. Each item of the scale is evaluated using a five-point scale scored from 1 to 5. Psychometric results demonstrated that the Turkish version of the scale was valid and reliable (Acet et al., 2020).
  measure: Change in The Impact of Event Scale-Revised
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
  description: The scale was developed to assess traumatic stress symptoms (Weiss,2004). It consists of 22 items, which are evaluated using a Likert scale scored from 0 to 4. The scale comprises three subscales. These are intrusion, avoidance, and hyperarousal . The adaptation of the scale to Turkish was conducted by Çorapçıoğlu and colleagues (2006). Within the scope of the current study, intrusions and avoidance were used to assess automatic meaning-making efforts.
  measure: Change in Acceptance and Action Questionnaire-II
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
  description: The Acceptance and Action Questionnaire-II (AAQ-II) was developed to measure psychological inflexibility/flexibility (Bond et al., 2011). The scale consists of a total of seven items, each of which is rated on a seven-point scale scored from 1 to 7. Higher scores on the scale indicate higher levels of psychological inflexibility. The scale has been adapted into Turkish by Meunier and colleagues (2014).Turkish version of the scale demonstrated adequate psychometric properties.
  measure: Change in The Hospital Anxiety and Depression Scale
  time frame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
  description: The scale was developed by Zigmond and Snaith (1983) to assess the levels of depression and anxiety in individuals diagnosed with various physical illnesses. The scale consists of a total of 14 items, with seven items evaluating anxiety and another seven items assessing depression levels. Participants are asked to rate each item on a four-point scale ranging from 0 to 3. The Turkish validity and reliability study of the Hospital Anxiety and Depression Scale (HADS) was conducted by Aydemir and colleagues (1997). The HADS is a valid and reliable measurement tool for assessing anxiety and depression levels in samples with a medical diagnosis.
  arm group label: Online Individual Intervention Program
  arm group type: Experimental
  description: The online intervention program (namely, Meaning-Centered Coping Program) consists of eight individual sessions, each lasting approximately 60 min. Sessions were conducted per week.
  arm group label: No Intervention: Waitlist Control Group
  arm group type: No Intervention
  description: A wait-list control group was used. Participants assigned to the wait-list control group did not receive the intervention immediately. After the final assessment was administered (eight weeks later since the initial assessment), they were able to participate in the same intervention program if they wanted.
  intervention type: Other
  intervention name: Meaning Centered Coping Program
  description: Meaning Centered Coping Program is a psychological intervention program developed for women diagnosed with breast cancer, based on the Meaning Making Model (Park, 2010; Park and Folkman, 1997) and Wong's (2010) principles of Meaning Therapy. Each weekly session had specific topics. These are:
  Session 1: Guiding patients to tell the story of their breast cancer and psycho-education; Session 2: Encouraging patients to talk about the effects of breast cancer on their lives and learning to accept their difficult emotions; Session 3: Focusing on cognition through the meaning attributed to breast cancer; Session 4: Learning to take alternative perspectives and defusing their negative thoughts; Session 5: Exploring personal strengths; Session 6: İdentifying important life values and moving toward value-based actions; Session 7: Finding meaning in breast cancer and life; Session 8: Focusing on Future plans and hopes
  arm group label: Online Individual Intervention Program
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The study included women diagnosed with breast cancer. In this regard, biological sex was considered.
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Selva Ülbe
  role: Principal Investigator
  affiliation: Dokuz Eylul University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Dokuz Eylul University
  investigator full name: Selva Ülbe
  investigator title: Research Assistant
  mesh term: Breast Neoplasms
  sharing ipd: No