<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/NCT04414436</url>
  </required_header>
  <id_info>
    <org_study_id>9612</org_study_id>
    <nct_id>NCT04414436</nct_id>
  </id_info>
  <brief_title>A Guided Internet Intervention for Women Treated for Gynecological Cancer</brief_title>
  <acronym>GYNEA</acronym>
  <official_title>A Guided Internet Intervention for Women Treated for Gynecological Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VID Specialized University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</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>
      Gynecological cancers are the sixth most common cancer forms and the number of survivors is&#xD;
      increasing as a consequence of more efficient treatment and longer life span. As part of&#xD;
      regulary care after cancer treatment the women have five years of follow-up with the primary&#xD;
      focus on recurrence, aiming to increase survival. However, several studies have shown that&#xD;
      there is no evidence for this assumption on increased survival (ref). There are now suggested&#xD;
      alternative perspectives in the follow up period targeting late effects, health-related&#xD;
      quality of life (QoL) and patient satisfaction with care.The main aim of the current study is&#xD;
      to test the feasibility and acceptability of an internet-based psychosocial intervention for&#xD;
      women treated with curative intent gynecological cancer. Another aim is to test the perceived&#xD;
      effect on gynecological cancer survivors health-related self-care and QoL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study's objectives and research questions Research questions&#xD;
&#xD;
        1. How did the participants use the program?&#xD;
&#xD;
             1. What are the barriers and facilitators concerning technologies of the&#xD;
                internet-based self -management intervention?&#xD;
&#xD;
             2. Number of logins&#xD;
&#xD;
             3. How much time did the participants spend on the program (per login )&#xD;
&#xD;
             4. Number of modules completed, number of home-work and mindfulness assignment&#xD;
                completed&#xD;
&#xD;
             5. Type of errors made …&#xD;
&#xD;
        2. What is the participants' perceived credibility of the program?&#xD;
&#xD;
        3. How do the participants experience the guided psychosocial digital intervention?&#xD;
&#xD;
             1. How do participants experience the cancer trajectory, their every-day lives and&#xD;
                health-related QoL post-treatment gynaecological cancer (before the intervention)?&#xD;
&#xD;
             2. How do the participants experience the internet-based intervention regarding&#xD;
                content, the home-work assignments, and the mindfulness assignments, the active&#xD;
                participation?&#xD;
&#xD;
             3. How do the participants experience the telephone-contact and follow-ups with the&#xD;
                nurse once a week?&#xD;
&#xD;
             4. Which factors do they describe as important for their satisfaction and&#xD;
                dissatisfaction&#xD;
&#xD;
        4. How is the perceived effect on the gynecological cancer survivors' competence, QoL,&#xD;
           self-care and coping?&#xD;
&#xD;
      It is hypothesized that an internet-based psycho-social intervention will support women in&#xD;
      developing self-competence and self-care which could be measured as increased QOL and&#xD;
      secondarily affect the impact of cancer, distress, anxiety, depression, self-esteem, and&#xD;
      self-reported ability to monitor and respond to symptoms of recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 25, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>study participants will be identified with an anonymous ID</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The Impact of Cancer version 2</measure>
    <time_frame>up to 26 weeks</time_frame>
    <description>Designed to assess the physical and psychosocial health experience of cancer survivors through its positive and negative impacts. 47-item questionnaire organized into 4 positive (altruism and empathy (AE), health awareness (HA), meaning of cancer (MOC), positive self-evaluation (PSE)) and 4 negative (appearance concerns (AC), body change concerns (BCC), life interference (LI) and worry (W)) impact dimensions [13] corresponding to the first 37 items. The questionnaire also includes 10 additional items constituting conditional dimensions applicable to subsets of survivors assessing employment concerns (EC), relationship concerns for individuals with a partner (P), and relationship concerns for those without a partner (NP). All items are scored on a five-point scale from 1 = strongly disagree to 5 = strongly agree. A higher score on a dimension implies stronger endorsement of that content area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Quality of Life Patient/Cancer Survivor Version</measure>
    <time_frame>up to 26 weeks</time_frame>
    <description>ordinal questionnaire measuring the quality of life in cancer patients over 42 items rated on 10 point Likert-type scale. The revised instrument included 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>up to 26 weeks</time_frame>
    <description>Subjects indicated for each of the nine depressive symptoms (corresponding to the criteria ofDSM-IV) whether, during the previous 2 weeks, the symptom has bothered them: 0=not at all; 1=several days; 2=more than half of the days; 3=nearly every day.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>GYNEA- digital coping program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive active treatment after the inclusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>6 weeks waiting list before crossing over to GYNEA- digital coping program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GYNEA- digital coping program for women after gynaecological cancer</intervention_name>
    <description>6 modules with relevant information and tools for coping after cancer</description>
    <arm_group_label>GYNEA- digital coping program</arm_group_label>
    <other_name>waiting list</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  have had gyneocological cancer&#xD;
&#xD;
          -  maximum 1 year after gynecological cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe medical or psychiatric condition&#xD;
&#xD;
          -  relapse of gynecological cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>gyneocological cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tine Nordgreen, PhD</last_name>
    <phone>+4790094913</phone>
    <email>tine.nordgreen@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ragnhild Sekse</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bergen Municipality Division School</name>
      <address>
        <city>Bergen</city>
        <state>Vestland</state>
        <zip>5003</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Britt Darlington, Advisor</last_name>
      <phone>53033443</phone>
      <email>britt.darlington@bergen.kommune.no</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5020</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tine Nordgreen, PhD</last_name>
      <phone>90094913</phone>
      <email>tine.nordgreen@helse-bergen.no</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04414436
org study id: 9612
nct id: NCT04414436
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Gynecological cancers are the sixth most common cancer forms and the number of survivors is
      increasing as a consequence of more efficient treatment and longer life span. As part of
      regulary care after cancer treatment the women have five years of follow-up with the primary
      focus on recurrence, aiming to increase survival. However, several studies have shown that
      there is no evidence for this assumption on increased survival (ref). There are now suggested
      alternative perspectives in the follow up period targeting late effects, health-related
      quality of life (QoL) and patient satisfaction with care.The main aim of the current study is
      to test the feasibility and acceptability of an internet-based psychosocial intervention for
      women treated with curative intent gynecological cancer. Another aim is to test the perceived
      effect on gynecological cancer survivors health-related self-care and QoL.
The study's objectives and research questions Research questions

        1. How did the participants use the program?

             1. What are the barriers and facilitators concerning technologies of the
                internet-based self -management intervention?

             2. Number of logins

             3. How much time did the participants spend on the program (per login )

             4. Number of modules completed, number of home-work and mindfulness assignment
                completed

             5. Type of errors made …

        2. What is the participants' perceived credibility of the program?

        3. How do the participants experience the guided psychosocial digital intervention?

             1. How do participants experience the cancer trajectory, their every-day lives and
                health-related QoL post-treatment gynaecological cancer (before the intervention)?

             2. How do the participants experience the internet-based intervention regarding
                content, the home-work assignments, and the mindfulness assignments, the active
                participation?

             3. How do the participants experience the telephone-contact and follow-ups with the
                nurse once a week?

             4. Which factors do they describe as important for their satisfaction and
                dissatisfaction

        4. How is the perceived effect on the gynecological cancer survivors' competence, QoL,
           self-care and coping?

      It is hypothesized that an internet-based psycho-social intervention will support women in
      developing self-competence and self-care which could be measured as increased QOL and
      secondarily affect the impact of cancer, distress, anxiety, depression, self-esteem, and
      self-reported ability to monitor and respond to symptoms of recurrence.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks
primary purpose: Supportive Care
masking: Single (Participant)
masking description: study participants will be identified with an anonymous ID
measure: The Impact of Cancer version 2
time frame: up to 26 weeks
description: Designed to assess the physical and psychosocial health experience of cancer survivors through its positive and negative impacts. 47-item questionnaire organized into 4 positive (altruism and empathy (AE), health awareness (HA), meaning of cancer (MOC), positive self-evaluation (PSE)) and 4 negative (appearance concerns (AC), body change concerns (BCC), life interference (LI) and worry (W)) impact dimensions [13] corresponding to the first 37 items. The questionnaire also includes 10 additional items constituting conditional dimensions applicable to subsets of survivors assessing employment concerns (EC), relationship concerns for individuals with a partner (P), and relationship concerns for those without a partner (NP). All items are scored on a five-point scale from 1 = strongly disagree to 5 = strongly agree. A higher score on a dimension implies stronger endorsement of that content area
measure: The Quality of Life Patient/Cancer Survivor Version
time frame: up to 26 weeks
description: ordinal questionnaire measuring the quality of life in cancer patients over 42 items rated on 10 point Likert-type scale. The revised instrument included 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.
measure: Patient Health Questionnaire
time frame: up to 26 weeks
description: Subjects indicated for each of the nine depressive symptoms (corresponding to the criteria ofDSM-IV) whether, during the previous 2 weeks, the symptom has bothered them: 0=not at all; 1=several days; 2=more than half of the days; 3=nearly every day.
arm group label: GYNEA- digital coping program
arm group type: Experimental
description: Participants randomized to this arm will receive active treatment after the inclusion
arm group label: Waiting list
arm group type: No Intervention
description: 6 weeks waiting list before crossing over to GYNEA- digital coping program
intervention type: Behavioral
intervention name: GYNEA- digital coping program for women after gynaecological cancer
description: 6 modules with relevant information and tools for coping after cancer
arm group label: GYNEA- digital coping program
other name: waiting list
criteria: 
gender: Female
gender based: Yes
gender description: gyneocological cancer
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tine Nordgreen, PhD
phone: +4790094913
email: tine.nordgreen@gmail.com
last name: Ragnhild Sekse
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Sponsor