<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/NCT03270995</url>
  </required_header>
  <id_info>
    <org_study_id>RCT FCR</org_study_id>
    <nct_id>NCT03270995</nct_id>
  </id_info>
  <brief_title>Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study</brief_title>
  <official_title>Efficacy of a Cognitive-existential Intervention to Address Fear of Recurrence in Women With Cancer: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Cancer Society (CCS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Mortimer B. Davis - Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies show that cancer survivors have unmet needs, the most frequently cited being fear of&#xD;
      recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of&#xD;
      cancer patients and are more prevalent among women. FCR is associated with psychological&#xD;
      distress, lower quality of life, and increased health care utilization. Little evidence&#xD;
      exists that these problems are being addressed by current medical management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study aims to further test this cognitive-existential group intervention for FCR&#xD;
      in a randomized control clinical trial with women with breast or gynecological cancer.&#xD;
      Participants will be recruited from Princess Margaret Hospital, Mount Sinai Hospital, the&#xD;
      Jewish General Hospital, and the Ottawa Hospital. 144 cancer patients will be randomized to&#xD;
      either receive the 6 week cognitive-existential group intervention or to a control group. The&#xD;
      control group will also consist of six weekly sessions during which participants will discuss&#xD;
      the challenges of living with a cancer diagnosis, but without a clear focus on FCR. Women&#xD;
      randomized to participate in the study will a) be 18 years or older; b) have a first&#xD;
      diagnosis of breast or gynecological cancer with stages between IIII; c) be disease free at&#xD;
      the start of the group; d) gave clinical levels of fear of cancer recurrence; e) have&#xD;
      clinical levels of distress; and f) have completed their cancer treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fear of cancer recurrence inventory</measure>
    <time_frame>up to 12 months post-intervention follow-up</time_frame>
    <description>Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item questionnaire that includes a global score as well as seven sub-scales including triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. A score of 13 or greater on the nine-item severity subscale (range 0-36) indicates clinical level of FCR [55]. The instrument has been shown to have adequate reliability and validity (construct validity; r=0.68 to 0.77; and reliability scores; α=0.95).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific distress</measure>
    <time_frame>Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention</time_frame>
    <description>Cancer-specific distress with the Impact of Event Scale (IES)]; The IES is a 15 items questionnaires that assesses cancer distress. It has two sub-scales, intrusive thoughts and avoidance, which provide a total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived risk of cancer recurrence</measure>
    <time_frame>Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention</time_frame>
    <description>Perceived risk of cancer recurrence will be assessed using a one-item question where respondents indicate their level of perceived personal risk for a cancer recurrence over the last two days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intolerance of uncertainty</measure>
    <time_frame>Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention</time_frame>
    <description>Intolerance of uncertainty with be measured with the Intolerance of Uncertainty Scale (IUS) [58]. The IUS is a 27-item four-factor questionnaire that represents uncertainty as stressful and upsetting, uncertainty as leading to the inability to act, uncertain events as being negative and to be avoided, and being uncertain as unfair.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncertainty in Illness</measure>
    <time_frame>Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention</time_frame>
    <description>Uncertainty in Illness will be measured by the Mishel Uncertainty in Illness Scale (MUIS-C) [59]. The MUIS-C consists of 23 items rated on a five-point Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Breast Neoplasms</condition>
  <condition>Ovarian Neoplasms</condition>
  <condition>Endometrial Neoplasms</condition>
  <condition>Uterine Cervical Neoplasms</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Existential Therapy Group 1</intervention_name>
    <description>Six group sessions of two hour each using a cognitive-existential group approach</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive Therapy Group 2</intervention_name>
    <description>Six group session of two hour each using a supportive group approach.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. first diagnosis of BC or GC with stages between I-III;&#xD;
&#xD;
          2. disease-free at the start of the group;&#xD;
&#xD;
          3. women aged 18 years or older;&#xD;
&#xD;
          4. completion of treatment, with the exception of adjuvant chemotherapy or hormonal&#xD;
             replacement therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. non-English speakers&#xD;
&#xD;
          2. previous cancer recurrence&#xD;
&#xD;
          3. enrolled in another group psychotherapy at the time of the start of the study or&#xD;
             during the course of the 6 sessions&#xD;
&#xD;
          4. unresolved mental health disorder judged to be clinically contra-indicated and/or&#xD;
             likely to affect the group work, based on disclosure by the potential participant or&#xD;
             clinically identified by the group leader.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Maheu, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University and University Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 2A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/27112319</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Maheu C, Lebel S, Courbasson C, Lefebvre M, Singh M, Bernstein LJ, Muraca L, Benea A, Jolicoeur L, Harris C, Ramanakumar AV, Ferguson S, Sidani S. Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer. BMC Cancer. 2016 Apr 25;16:291. doi: 10.1186/s12885-016-2326-x.</citation>
    <PMID>27112319</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>March 17, 2016</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Christine Maheu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>gynecological cancer</keyword>
  <keyword>fear of cancer recurrence</keyword>
  <keyword>clinical trial</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>group therapy</keyword>
  <keyword>intervention</keyword>
  <keyword>cognitive-existential</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03270995
org study id: RCT FCR
nct id: NCT03270995
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Studies show that cancer survivors have unmet needs, the most frequently cited being fear of
      recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of
      cancer patients and are more prevalent among women. FCR is associated with psychological
      distress, lower quality of life, and increased health care utilization. Little evidence
      exists that these problems are being addressed by current medical management.
The present study aims to further test this cognitive-existential group intervention for FCR
      in a randomized control clinical trial with women with breast or gynecological cancer.
      Participants will be recruited from Princess Margaret Hospital, Mount Sinai Hospital, the
      Jewish General Hospital, and the Ottawa Hospital. 144 cancer patients will be randomized to
      either receive the 6 week cognitive-existential group intervention or to a control group. The
      control group will also consist of six weekly sessions during which participants will discuss
      the challenges of living with a cancer diagnosis, but without a clear focus on FCR. Women
      randomized to participate in the study will a) be 18 years or older; b) have a first
      diagnosis of breast or gynecological cancer with stages between IIII; c) be disease free at
      the start of the group; d) gave clinical levels of fear of cancer recurrence; e) have
      clinical levels of distress; and f) have completed their cancer treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Fear of cancer recurrence inventory
time frame: up to 12 months post-intervention follow-up
description: Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item questionnaire that includes a global score as well as seven sub-scales including triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. A score of 13 or greater on the nine-item severity subscale (range 0-36) indicates clinical level of FCR [55]. The instrument has been shown to have adequate reliability and validity (construct validity; r=0.68 to 0.77; and reliability scores; α=0.95).
measure: Cancer-specific distress
time frame: Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
description: Cancer-specific distress with the Impact of Event Scale (IES)]; The IES is a 15 items questionnaires that assesses cancer distress. It has two sub-scales, intrusive thoughts and avoidance, which provide a total score.
measure: Perceived risk of cancer recurrence
time frame: Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
description: Perceived risk of cancer recurrence will be assessed using a one-item question where respondents indicate their level of perceived personal risk for a cancer recurrence over the last two days.
measure: Intolerance of uncertainty
time frame: Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
description: Intolerance of uncertainty with be measured with the Intolerance of Uncertainty Scale (IUS) [58]. The IUS is a 27-item four-factor questionnaire that represents uncertainty as stressful and upsetting, uncertainty as leading to the inability to act, uncertain events as being negative and to be avoided, and being uncertain as unfair.
measure: Uncertainty in Illness
time frame: Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
description: Uncertainty in Illness will be measured by the Mishel Uncertainty in Illness Scale (MUIS-C) [59]. The MUIS-C consists of 23 items rated on a five-point Likert scale.
arm group label: Group 1
arm group type: Experimental
description: Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions
arm group label: Group 2
arm group type: Active Comparator
description: Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions
intervention type: Behavioral
intervention name: Cognitive Existential Therapy Group 1
description: Six group sessions of two hour each using a cognitive-existential group approach
arm group label: Group 1
intervention type: Behavioral
intervention name: Supportive Therapy Group 2
description: Six group session of two hour each using a supportive group approach.
arm group label: Group 2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Maheu, RN, PhD
role: Principal Investigator
affiliation: McGill University and University Health Network
facility: 
facility: 
facility: 
country: Canada
url: https://www.ncbi.nlm.nih.gov/pubmed/27112319
description: Related Info
citation: Maheu C, Lebel S, Courbasson C, Lefebvre M, Singh M, Bernstein LJ, Muraca L, Benea A, Jolicoeur L, Harris C, Ramanakumar AV, Ferguson S, Sidani S. Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer. BMC Cancer. 2016 Apr 25;16:291. doi: 10.1186/s12885-016-2326-x.
PMID: 27112319
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Christine Maheu
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Uterine Cervical Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Recurrence
sharing ipd: No