<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/NCT01693991</url>
  </required_header>
  <id_info>
    <org_study_id>258431</org_study_id>
    <nct_id>NCT01693991</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of the Meaning-Making Intervention (MMi)</brief_title>
  <official_title>Randomized Controlled Trial of the Meaning-Making Intervention (MMi) in Patients Newly Diagnosed With Advanced Cancer: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jewish General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient&#xD;
      number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both&#xD;
      men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced&#xD;
      cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi&#xD;
      acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to complete&#xD;
      the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4 or 6&#xD;
      months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most&#xD;
      helpful? 4)What sample size is needed for a full study? Full-study research questions:&#xD;
      Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in life&#xD;
      among newly diagnosed ACP, compared with those receiving usual care plus meetings with an&#xD;
      empathic non-professional visitor (i.e., attention-control group or AC) or usual care alone&#xD;
      (UC), at x months post-randomization? (time determined in pilot) &quot;Meaning in life&quot; (primary&#xD;
      outcome) is defined as the belief that one's life has significance and purpose (i.e., global&#xD;
      meaning) and &quot;newly diagnosed ACP&quot; is defined as the 6 months after first occurrence of,&#xD;
      progression toward, or recurrence of stage III or IV cancer (TNM classification system).&#xD;
      Secondary: In our future full-study, we plan to evaluate MMi effects on secondary outcomes&#xD;
      such as existential wellbeing (MQOL existential wellbeing) and posttraumatic growth&#xD;
      (Post-Traumatic Growth Inventory). We also plan to test a theoretical model where sense of&#xD;
      meaning in life has a protective (moderating) effect on tertiary outcomes such as physical&#xD;
      QoL (MQOL physical subscale), anxiety and depression (Hospital Anxiety and Depression Scale&#xD;
      (HADS)), and overall QoL (MQOL Total) in EG patients. Methodology: RCT pilot study with 60&#xD;
      newly diagnosed ACP (stages III or IV) within 2 months of referral and 6 months of&#xD;
      randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC. Patients will complete&#xD;
      self-report questionnaires (including outcome measures, as well as sociodemographic and&#xD;
      medical variables) at 2, 4 and 6 months post-randomization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      See above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>2 months post randomization</time_frame>
    <description>Can we recruit a sufficient number (i.e., 60 patients over 9 months or 6.7 per month) of newly diagnosed advanced cancer patients? AND&#xD;
Can we retain a sufficient proportion of both men and women (i.e., at least 80%) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>2 months post-randomization</time_frame>
    <description>Is the MMi acceptable to at least 80% of men and women with advanced cancer, as indicated by 80% positive responses on the Pilot-Study Questionnaire (PSQ; adapted from the CSQ-8; Attkisson &amp; Zwick, 1982) Q#7 (score 3 or 4), Q#8, and Q#9 (score 5, 6 or 7).&#xD;
PSQ Q#7: Would you recommend those types of meetings to other people in your situation? 1= no, definitively not; 2= no, I don't think so; 3= yes, I think so; 4= yes, definitively PSQ Q#8: Were the meetings acceptable? PSQ Q#9: On the whole, how positive or negative was your experience of the meetings? 1= Totally negative; 2= Very negative; 3= A little negative; 4= Neutral; 5= A little positive; 6= Very positive; 7= Totally positive</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timing of the intervention</measure>
    <time_frame>2 month post-randomization</time_frame>
    <description>Will at least 95% of EG and AC patients complete the intervention in 3-4 weeks?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary evaluation time</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Which evaluation time should be primary, 2, 4 or 6 months post-randomization, based on an acceptable retention rate of 80%?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment strategies</measure>
    <time_frame>2 months post-randomization</time_frame>
    <description>Which recruitment strategies are most effective, defined as the strategies recruiting the largest % of participants. Strategies recruiting &lt;5% of participants will be considered unhelpful. All participants will be queried as to how they found out about the study. Recruitment strategies will include: being recruiting directly through the treating team, posted ads in recruiting oncology clinics, use of local media (newspaper and radio interviews), and creation of a website linked with the Jewish General Hospital and the McGill University Health Centre.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sample size calculation for the full study</measure>
    <time_frame>2 months post-randomization</time_frame>
    <description>What is the 80% upper confidence interval for the standard deviation at baseline?</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Meaning-Making intervention (MMi)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will be receiving the Meaning-Making intervention (MMi) as per intervention manual (Lee, 2006).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empathic visitor</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his feelings and thoughts, understands his/her illness and meaning in life), and focus discussions on what is currently happening (rather than on the interface between past and present).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will only be receiving treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meaning-Making intervention (MMi)</intervention_name>
    <description>MMi and attention control sessions will take place weekly for 3 weeks at the patient's home or hospital, as the patient prefers. We will try to limit delays to no more than 1 week if needed (e.g., for recovery from treatment side-effects), but because the feasibility of this schedule is one of the research questions, if more flexibility is required we will not withdraw people from the study if the delay is longer, since a longer intervention period could be incorporated in a full-scale RCT. Dates and duration of each session will be tracked. MMi sessions will be conducted by 2 bilingual mental health professionals (nurse, social worker, or psychologist) with at least 1 year of clinical oncology experience and will be initiated within 1 week after randomization.</description>
    <arm_group_label>Meaning-Making intervention (MMi)</arm_group_label>
    <other_name>MMi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Empathic visitor</intervention_name>
    <description>This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his feelings and thoughts, understands his/her illness and meaning in life), and focus discussions on what is currently happening (rather than on the interface between past and present).</description>
    <arm_group_label>Empathic visitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: 1) Diagnosed with advanced cancer (stage III or IV --TNM classification&#xD;
        system; 117); first occurrence, progression or recurrence) of any type of solid tumour &lt;2&#xD;
        months at referral and &lt;6 months at randomization. 2) Willing to participate in weekly MMi&#xD;
        or AC sessions. 3) &gt;18 years. 4) Alert and capable of giving free and informed consent. 5)&#xD;
        Able to speak and read English or French. Exclusion Criteria: 1) Karnofsky Performance&#xD;
        Status (KPS) score &lt;60 (rated by referring oncologists/nurses or Research Coordinator (RC))&#xD;
        or expected survival &lt;6 months according to clinical judgment. 2) Currently receiving&#xD;
        radiotherapy (Rx) treatment (although these patients can be reassessed after Rx). Patients&#xD;
        will only be included in the study when they have recovered from severe side-effects from&#xD;
        Rx and when they feel they can participate in the study. Severe side-effects are defined as&#xD;
        a score of 3 or 4 on any of the site-specific toxicity markers of the Eastern Cooperative&#xD;
        Oncology Group (ECOG) Common Toxicity Criteria or with more than 3 markers with a score of&#xD;
        2 (moderate side-effects), as evaluated by the treating physician (in consultation with the&#xD;
        radiotherapist. 3) Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI)&#xD;
        suicide item (item #9), administered by the RC or RA during the consent meeting. 4) Known&#xD;
        diagnosis of schizophrenia or schizoaffective disorder. 5) Planning a trip within 2 months&#xD;
        that would interrupt delivery of the MMi or AC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Henry, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>S Robin Cohen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Melissa Henry</investigator_full_name>
    <investigator_title>Psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01693991
org study id: 258431
nct id: NCT01693991
lead sponsor: 
has dmc: No
Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient
      number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both
      men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced
      cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi
      acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to complete
      the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4 or 6
      months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most
      helpful? 4)What sample size is needed for a full study? Full-study research questions:
      Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in life
      among newly diagnosed ACP, compared with those receiving usual care plus meetings with an
      empathic non-professional visitor (i.e., attention-control group or AC) or usual care alone
      (UC), at x months post-randomization? (time determined in pilot) "Meaning in life" (primary
      outcome) is defined as the belief that one's life has significance and purpose (i.e., global
      meaning) and "newly diagnosed ACP" is defined as the 6 months after first occurrence of,
      progression toward, or recurrence of stage III or IV cancer (TNM classification system).
      Secondary: In our future full-study, we plan to evaluate MMi effects on secondary outcomes
      such as existential wellbeing (MQOL existential wellbeing) and posttraumatic growth
      (Post-Traumatic Growth Inventory). We also plan to test a theoretical model where sense of
      meaning in life has a protective (moderating) effect on tertiary outcomes such as physical
      QoL (MQOL physical subscale), anxiety and depression (Hospital Anxiety and Depression Scale
      (HADS)), and overall QoL (MQOL Total) in EG patients. Methodology: RCT pilot study with 60
      newly diagnosed ACP (stages III or IV) within 2 months of referral and 6 months of
      randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC. Patients will complete
      self-report questionnaires (including outcome measures, as well as sociodemographic and
      medical variables) at 2, 4 and 6 months post-randomization.
See above
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Feasibility
time frame: 2 months post randomization
description: Can we recruit a sufficient number (i.e., 60 patients over 9 months or 6.7 per month) of newly diagnosed advanced cancer patients? AND
Can we retain a sufficient proportion of both men and women (i.e., at least 80%) with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years?
measure: Acceptability
time frame: 2 months post-randomization
description: Is the MMi acceptable to at least 80% of men and women with advanced cancer, as indicated by 80% positive responses on the Pilot-Study Questionnaire (PSQ; adapted from the CSQ-8; Attkisson & Zwick, 1982) Q#7 (score 3 or 4), Q#8, and Q#9 (score 5, 6 or 7).
PSQ Q#7: Would you recommend those types of meetings to other people in your situation? 1= no, definitively not; 2= no, I don't think so; 3= yes, I think so; 4= yes, definitively PSQ Q#8: Were the meetings acceptable? PSQ Q#9: On the whole, how positive or negative was your experience of the meetings? 1= Totally negative; 2= Very negative; 3= A little negative; 4= Neutral; 5= A little positive; 6= Very positive; 7= Totally positive
measure: Timing of the intervention
time frame: 2 month post-randomization
description: Will at least 95% of EG and AC patients complete the intervention in 3-4 weeks?
measure: Primary evaluation time
time frame: 6 months post-randomization
description: Which evaluation time should be primary, 2, 4 or 6 months post-randomization, based on an acceptable retention rate of 80%?
measure: Recruitment strategies
time frame: 2 months post-randomization
description: Which recruitment strategies are most effective, defined as the strategies recruiting the largest % of participants. Strategies recruiting <5% of participants will be considered unhelpful. All participants will be queried as to how they found out about the study. Recruitment strategies will include: being recruiting directly through the treating team, posted ads in recruiting oncology clinics, use of local media (newspaper and radio interviews), and creation of a website linked with the Jewish General Hospital and the McGill University Health Centre.
measure: Sample size calculation for the full study
time frame: 2 months post-randomization
description: What is the 80% upper confidence interval for the standard deviation at baseline?
arm group label: Meaning-Making intervention (MMi)
arm group type: Experimental
description: Patients in this arm will be receiving the Meaning-Making intervention (MMi) as per intervention manual (Lee, 2006).
arm group label: Empathic visitor
arm group type: Placebo Comparator
description: This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his feelings and thoughts, understands his/her illness and meaning in life), and focus discussions on what is currently happening (rather than on the interface between past and present).
arm group label: Control Group
arm group type: No Intervention
description: Patients in this group will only be receiving treatment as usual.
intervention type: Behavioral
intervention name: Meaning-Making intervention (MMi)
description: MMi and attention control sessions will take place weekly for 3 weeks at the patient's home or hospital, as the patient prefers. We will try to limit delays to no more than 1 week if needed (e.g., for recovery from treatment side-effects), but because the feasibility of this schedule is one of the research questions, if more flexibility is required we will not withdraw people from the study if the delay is longer, since a longer intervention period could be incorporated in a full-scale RCT. Dates and duration of each session will be tracked. MMi sessions will be conducted by 2 bilingual mental health professionals (nurse, social worker, or psychologist) with at least 1 year of clinical oncology experience and will be initiated within 1 week after randomization.
arm group label: Meaning-Making intervention (MMi)
other name: MMi
intervention type: Behavioral
intervention name: Empathic visitor
description: This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his feelings and thoughts, understands his/her illness and meaning in life), and focus discussions on what is currently happening (rather than on the interface between past and present).
arm group label: Empathic visitor
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Melissa Henry, Ph.D.
role: Principal Investigator
affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University
last name: S Robin Cohen, Ph.D.
role: Principal Investigator
affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital; and McGill University
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Jewish General Hospital
investigator full name: Melissa Henry
investigator title: Psychologist
mesh term: Neoplasms