<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20140212016564N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-12</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of group therapy on mental adjustment of the women with  gynecological cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of group therapy based on coping strategies on mental adjustment of the women with  gynecological cancer that referred to urmia education- research and treatment centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 150 women with gynecological cancer who were referred to treatment centers in the years 1395 and 1396 were selected. After reviewing the records of these patients and considering the inclusion and exclusion criteria and other criteria, 100 eligible patients were enrolled in the study. Considering that 70 patients were needed for intervention. A total of 70 individuals were randomly selected (random numbers). The method of assignment to groups was done in this way That: We put 35 A cards and 35 B cards in the envelope and mixed them thoroughly(Card A represents the intervention group and the B card index represents the control group), Then the cards are randomly arranged in a row. Anyone who entered the study was able to take one of the cards and enter the study, respectively. In this way, the intervention group and the control group were identified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gynecologic cancer.</hc_freetext>
      <i_freetext>Intervention 1: To implement the group therapy, the intervention group was divided into three small groups of 11-12-12 people, Each subgroup underwent a group therapy based on coping strategie which was held in eight sessions of 2 hours and one day per week. The group's force was used to create new methods and to have a positive impact on each other and learning from each other. At the end of each meeting, a homework assignment was provided for patients. Which was reviewed and rated at the next meeting at the end of the work, those who received more points were ewarded. The titles of the meetings were as follows:  The First meeting included introduction and familiarity of the group members with each other and explaining the principles of the group, the definition of cancer and the causes of cancerous cell and the presentation of an educational booklet prepared by the researcher for study, which included the knowledge that  help to alleviate patient anxiety.The second meeting included discussions about the fighting spirit, acceptance of their role, belief in their ability, and negative self-change. Third session included physical care such as: healthy eating, physical activity, changing the style of life, accepting responsibility and seeking social support.The fourth session included a search for treatment, such as: Participation with the treatment team and follow-up therapy. The fifth session included psychological care such as: religious beliefs, valuing your interests, modifying negative beliefs, gaining emotional support, self-control and do not follow the culprit. The sixth session included the use of sedative techniques such as slow and deep breathing, mental imagery, thought leadership, realism, and complementary therapies such as laughter therapy and the use of relaxed speech.The seventh session included anti recurrence strategies, such as providing information on the recurrence of disease, the importance of pursuing health care and maintaining the fighting spirit.The Eighth session Scores recorded from each patient were reviewed and awarded to the highest score. one of the Cancer who were victorious in curing cancer, talked to patients. After the end of the sessions, a three month deadline was given to the team to carry out coping skills working in the group, in their daily lives. Assessment form of mental adaptation in cancer before the intervention; after intervention; one month after the intervention; and three months after the intervention was completed by patients. Intervention 2: During the intervention, the control group did not receive any coping skills and in terms of data entry was about control.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
File Title: Mental Adjustment Data
The whole data will be shared after being unidentified.

When:
Start the access period 6 months after printing the results

To whom:
Researchers working in academia

Conditions:
The data will be available to other researchers in the form of a printed article.
Other researchers are allowed from the research team  to use the data.

Where to obtain:
Radfar moloud 
Email:mradfar1343@gmail.com

How to obtain:
You will submit your application to Mrs. Radfar, who will send you the requested application within ten days after reviewing your request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Smaeilzadeh khangah Sepideh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3345 4810</telephone>
        <email>Sepideh29729784@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Radfar Moloud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3275 4964</telephone>
        <email>Mradfar1343@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with gynecological cancer
lack of participation in group therapy programs in the last three months
having Literacy reading and writing
ability to communicate
Passed at least six months after the onset of the disease
lack of distant metastases
Awareness of own illness
The desire to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of using Psychiatric drug
concurrent suffering with another chronic illness
Participation in psychiatric interventions simultaneously with research implementation
The emergence of an important stressful factor in life
A prominent history of mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C51-C58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms of female genital organs</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>To implement the group therapy, the intervention group was divided into three small groups of 11-12-12 people, Each subgroup underwent a group therapy based on coping strategie which was held in eight sessions of 2 hours and one day per week. The group's force was used to create new methods and to have a positive impact on each other and learning from each other. At the end of each meeting, a homework assignment was provided for patients. Which was reviewed and rated at the next meeting at the end of the work, those who received more points were ewarded. The titles of the meetings were as follows:  The First meeting included introduction and familiarity of the group members with each other and explaining the principles of the group, the definition of cancer and the causes of cancerous cell and the presentation of an educational booklet prepared by the researcher for study, which included the knowledge that  help to alleviate patient anxiety.The second meeting included discussions about the fighting spirit, acceptance of their role, belief in their ability, and negative self-change. Third session included physical care such as: healthy eating, physical activity, changing the style of life, accepting responsibility and seeking social support.The fourth session included a search for treatment, such as: Participation with the treatment team and follow-up therapy. The fifth session included psychological care such as: religious beliefs, valuing your interests, modifying negative beliefs, gaining emotional support, self-control and do not follow the culprit. The sixth session included the use of sedative techniques such as slow and deep breathing, mental imagery, thought leadership, realism, and complementary therapies such as laughter therapy and the use of relaxed speech.The seventh session included anti recurrence strategies, such as providing information on the recurrence of disease, the importance of pursuing health care and maintaining the fighting spirit.The Eighth session Scores recorded from each patient were reviewed and awarded to the highest score. one of the Cancer who were victorious in curing cancer, talked to patients. After the end of the sessions, a three month deadline was given to the team to carry out coping skills working in the group, in their daily lives. Assessment form of mental adaptation in cancer before the intervention; after intervention; one month after the intervention; and three months after the intervention was completed by patients.</i_keyword>
      <i_keyword>During the intervention, the control group did not receive any coping skills and in terms of data entry was about control.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of intervention (group therapy based on coping strategies) on mental adjustment of participants was assessed using the mental adjustment questionnaire in cancer in four stages before intervention, after intervention, one month after intervention and three months after intervention. And compared to the control group. Timepoint: Before the intervention immediately after the intervention one month later and three months after the intervention. Method of measurement: Mini-Menta lAadjustment to Cancer scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-09</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urjance alley, Resalat Blvd, Urmia, Iran urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
