<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/NCT03763825</url>
  </required_header>
  <id_info>
    <org_study_id>249571</org_study_id>
    <nct_id>NCT03763825</nct_id>
  </id_info>
  <brief_title>Mini-AFTERc Intervention for Fear of Cancer Recurrence</brief_title>
  <acronym>Mini-AFTERc</acronym>
  <official_title>A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of St Andrews</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Stirling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swansea University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chief Scientist Office of the Scottish Government</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of St Andrews</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      People treated for breast cancer often live with an ongoing fear that the cancer will recur.&#xD;
      This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc&#xD;
      study is a pilot trial of a brief cognitive behavioural communication intervention, designed&#xD;
      to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to&#xD;
      determine the acceptability and practicality of introducing the Mini-AFTERc intervention into&#xD;
      everyday practice, and inform the development of a full randomised controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this pilot trial are as follows:&#xD;
&#xD;
        1. To develop a procedure for training breast cancer nurses (BCN) in the delivery of the&#xD;
           Mini-AFTERc intervention and introduce the intervention into current NHS service&#xD;
           provision for breast cancer patients.&#xD;
&#xD;
        2. To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer&#xD;
           patients), the fidelity of intervention elements, the acceptability to participants&#xD;
           (primary and secondary outcomes) and detailed economic indicators for a full trial.&#xD;
&#xD;
        3. Apply a formal decision making framework (ADePT) to determine a profile of factors to&#xD;
           reveal potential difficulties and appraise solutions prior to a full trial.&#xD;
&#xD;
      This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will&#xD;
      take place in 4 breast cancer centres in NHS Scotland health boards, including Fife,&#xD;
      Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian)&#xD;
      and 2 centres will deliver usual care to patients, acting as control centres (Highlands and&#xD;
      Tayside). The project will be delivered in 3 phases:&#xD;
&#xD;
      Phase 1 will include the development and delivery of the Mini-AFTERc intervention training&#xD;
      package for breast cancer nurses.&#xD;
&#xD;
      Phase 2 will include patient recruitment and data collection. There will be 2 intervention&#xD;
      centres and 2 control centres across NHS Scotland. Patients who have completed their primary&#xD;
      breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and &lt;15 on the Fear&#xD;
      of Cancer Recurrence 4-item Scale; FCR4). Breast cancer nurses will deliver the intervention&#xD;
      by telephone in intervention centres, which will be audio recorded. Patients will complete a&#xD;
      satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires&#xD;
      measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes&#xD;
      (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months&#xD;
      following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control&#xD;
      group. Semi-structured interviews with 20% of patients and all nurses will be conducted to&#xD;
      assess experiences and acceptability of the intervention.&#xD;
&#xD;
      Phase 3 will conduct data analysis and trial evaluation. Screening and follow-up data will be&#xD;
      quantitatively analysed, including structured equation modelling. Interviews will be subject&#xD;
      to framework analysis based on normalisation process theory (NPT). The pilot trial will be&#xD;
      systematically evaluated using a process of decision making after pilot and feasibility&#xD;
      trials (ADePT).&#xD;
&#xD;
      The findings will help to understand if this brief intervention can be implemented in&#xD;
      everyday practice and can reduce FCR. They will also inform the practicality of&#xD;
      implementation of a larger-scale randomised trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 13, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction with nurse communication during the Mini-AFTERc intervention</measure>
    <time_frame>1 week post intervention</time_frame>
    <description>Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fear of cancer recurrence level - FCR4</measure>
    <time_frame>3 months</time_frame>
    <description>The FCR4 is a 4-item measure designed to assess patient anxiety, worry and strong feelings associated with the return of cancer (e.g. 'I am afraid that my cancer may recur'). The research group has validated the FCR4 as an accurate measure of cancer recurrence fears in breast cancer patients that is fit for routine use in clinical services (Humphris, Watson, Sharpe, &amp; Ozakinci, 2018). Each question in the FCR4 is rated by the patient on a scale of 1 ('Not at all') to 5 ('All the time'). A cumulative score of ≥10 (60 Percentile) across all 4 items is defined as 'moderate' fear of cancer recurrence and a cumulative score of ≥15 is defined as 'high' fear of cancer recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>3 months</time_frame>
    <description>The HADS is a 14-item assessment tool used to screen for anxiety and depression the general medical population (Zigmond &amp; Snaith, 1983). The HADS is well established tool and has been employed in a multitude of medical settings, including oncology, to assess patients' mental health (Hartung et al., 2017; Vodermaier &amp; Millman, 2011). The HADS assesses two domains, depressionand anxiety. Patients report symptoms of depression and anxiety in the last week on a 4-point Likert scale, from 0 (e.g. &quot;Not at all&quot;) to 3 (e.g. &quot;Most of the time&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)</measure>
    <time_frame>3 months</time_frame>
    <description>The EQ-5D is a standardised instrument of health-related quality of life, developed by the EuroQol Group (Herdman et al., 2011). The EQ-5D assesses 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D contains 6-items, 5 of these items assess each of the 5 dimensions and are rated on a 5-level (5L) scale. The final item is a measure of health state, which is rated on a scale of 0 ('worst imaginable health state') to 100 (Best imaginable health state').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews</measure>
    <time_frame>Within 1 month of delivering final intervention</time_frame>
    <description>Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of breast cancer nurses. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>Duration of the pilot trial (Approx 2 years)</time_frame>
    <description>Assess number of patients recruited at each site, including those who decline to participate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention rate</measure>
    <time_frame>Duration of the pilot trial (Approx 2 years)</time_frame>
    <description>Assess number of patients who complete the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition rate</measure>
    <time_frame>Duration of the pilot trial (Approx 2 years)</time_frame>
    <description>Assess number of patients who do not complete the trial, withdraw or drop-out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews</measure>
    <time_frame>Within 1 month of final follow-up questionnaire</time_frame>
    <description>Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of patients. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">133</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Fear of Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive usual care after completion of primary breast cancer treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mini-AFTERc</intervention_name>
    <description>Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient inclusion criteria for screening:&#xD;
&#xD;
          -  Completed primary cancer treatment.&#xD;
&#xD;
          -  Cancer-free.&#xD;
&#xD;
          -  Female.&#xD;
&#xD;
          -  Responsible clinician agrees to their participation.&#xD;
&#xD;
        Patient inclusion criteria for trial:&#xD;
&#xD;
          -  Score 'moderate' (≥10 and &lt;15) on the Fear of Cancer Recurrence 4-item scale (FCR4)&#xD;
             during screening.&#xD;
&#xD;
        Patient exclusion criteria:&#xD;
&#xD;
          -  Not completed primary cancer treatment.&#xD;
&#xD;
          -  Not cancer-free.&#xD;
&#xD;
          -  Male.&#xD;
&#xD;
          -  A diagnosed psychotic disorder, known to the cancer service, for which the patient is&#xD;
             currently receiving treatment.&#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_contact>
    <last_name>Gerry M Humphris, PhD</last_name>
    <phone>+44 (0) 1334463565</phone>
    <email>gmh4@st-andrews.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Calum T McHale, PhD</last_name>
    <phone>+44 (0)1334461895</phone>
    <email>ctm2@st-andrews.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Queen Margaret Hospital</name>
      <address>
        <city>Dunfermline</city>
        <state>NHS Fife</state>
        <zip>KY12 0SU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raigmore Hospital</name>
      <address>
        <city>Inverness</city>
        <state>NHS Highlands</state>
        <zip>IV2 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <state>NHS Lothain</state>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perth Royal Infirmary</name>
      <address>
        <city>Perth</city>
        <state>NHS Tayside</state>
        <zip>PH1 1NX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Davidson J, Malloch M, Humphris G. A single-session intervention (the Mini-AFTERc) for fear of cancer recurrence: A feasibility study. Psychooncology. 2018 Nov;27(11):2668-2670. doi: 10.1002/pon.4724. Epub 2018 Apr 30. No abstract available.</citation>
    <PMID>29624779</PMID>
  </reference>
  <reference>
    <citation>Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018 Feb 9;16(1):30. doi: 10.1186/s12955-018-0850-x.</citation>
    <PMID>29471823</PMID>
  </reference>
  <reference>
    <citation>Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.</citation>
    <PMID>6880820</PMID>
  </reference>
  <reference>
    <citation>Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.</citation>
    <PMID>21479777</PMID>
  </reference>
  <reference>
    <citation>Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.</citation>
    <PMID>15528286</PMID>
  </reference>
  <reference>
    <citation>Cruickshank S, Steel E, Fenlon D, Armes J, Scanlon K, Banks E, Humphris G. A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol. Pilot Feasibility Stud. 2017 Jul 20;4:22. doi: 10.1186/s40814-017-0161-8. eCollection 2018. Erratum In: Pilot Feasibility Stud. 2017 Oct 24;3:48.</citation>
    <PMID>28748105</PMID>
  </reference>
  <reference>
    <citation>Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751.</citation>
    <PMID>18492319</PMID>
  </reference>
  <reference>
    <citation>Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.</citation>
    <PMID>24160371</PMID>
  </reference>
  <reference>
    <citation>Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.</citation>
    <PMID>20961442</PMID>
  </reference>
  <reference>
    <citation>Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Mehnert A. The Hospital Anxiety and Depression Scale (HADS) and the 9-item Patient Health Questionnaire (PHQ-9) as screening instruments for depression in patients with cancer. Cancer. 2017 Nov 1;123(21):4236-4243. doi: 10.1002/cncr.30846. Epub 2017 Jun 27.</citation>
    <PMID>28654189</PMID>
  </reference>
  <reference>
    <citation>Vodermaier A, Millman RD. Accuracy of the Hospital Anxiety and Depression Scale as a screening tool in cancer patients: a systematic review and meta-analysis. Support Care Cancer. 2011 Dec;19(12):1899-908. doi: 10.1007/s00520-011-1251-4. Epub 2011 Sep 4.</citation>
    <PMID>21898134</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of St Andrews</investigator_affiliation>
    <investigator_full_name>Prof G Humphris</investigator_full_name>
    <investigator_title>Professor of Health Psychology</investigator_title>
  </responsible_party>
  <keyword>fear of recurrence</keyword>
  <keyword>cancer</keyword>
  <keyword>brief intervention</keyword>
  <keyword>telephone counselling</keyword>
  <keyword>following primary cancer treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Recurrence</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/NCT03763825
org study id: 249571
nct id: NCT03763825
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People treated for breast cancer often live with an ongoing fear that the cancer will recur.
      This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc
      study is a pilot trial of a brief cognitive behavioural communication intervention, designed
      to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to
      determine the acceptability and practicality of introducing the Mini-AFTERc intervention into
      everyday practice, and inform the development of a full randomised controlled trial.
The objectives of this pilot trial are as follows:

        1. To develop a procedure for training breast cancer nurses (BCN) in the delivery of the
           Mini-AFTERc intervention and introduce the intervention into current NHS service
           provision for breast cancer patients.

        2. To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer
           patients), the fidelity of intervention elements, the acceptability to participants
           (primary and secondary outcomes) and detailed economic indicators for a full trial.

        3. Apply a formal decision making framework (ADePT) to determine a profile of factors to
           reveal potential difficulties and appraise solutions prior to a full trial.

      This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will
      take place in 4 breast cancer centres in NHS Scotland health boards, including Fife,
      Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian)
      and 2 centres will deliver usual care to patients, acting as control centres (Highlands and
      Tayside). The project will be delivered in 3 phases:

      Phase 1 will include the development and delivery of the Mini-AFTERc intervention training
      package for breast cancer nurses.

      Phase 2 will include patient recruitment and data collection. There will be 2 intervention
      centres and 2 control centres across NHS Scotland. Patients who have completed their primary
      breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and <15 on the Fear
      of Cancer Recurrence 4-item Scale; FCR4). Breast cancer nurses will deliver the intervention
      by telephone in intervention centres, which will be audio recorded. Patients will complete a
      satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires
      measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes
      (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months
      following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control
      group. Semi-structured interviews with 20% of patients and all nurses will be conducted to
      assess experiences and acceptability of the intervention.

      Phase 3 will conduct data analysis and trial evaluation. Screening and follow-up data will be
      quantitatively analysed, including structured equation modelling. Interviews will be subject
      to framework analysis based on normalisation process theory (NPT). The pilot trial will be
      systematically evaluated using a process of decision making after pilot and feasibility
      trials (ADePT).

      The findings will help to understand if this brief intervention can be implemented in
      everyday practice and can reduce FCR. They will also inform the practicality of
      implementation of a larger-scale randomised trial.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient satisfaction with nurse communication during the Mini-AFTERc intervention
time frame: 1 week post intervention
description: Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.
measure: Fear of cancer recurrence level - FCR4
time frame: 3 months
description: The FCR4 is a 4-item measure designed to assess patient anxiety, worry and strong feelings associated with the return of cancer (e.g. 'I am afraid that my cancer may recur'). The research group has validated the FCR4 as an accurate measure of cancer recurrence fears in breast cancer patients that is fit for routine use in clinical services (Humphris, Watson, Sharpe, & Ozakinci, 2018). Each question in the FCR4 is rated by the patient on a scale of 1 ('Not at all') to 5 ('All the time'). A cumulative score of ≥10 (60 Percentile) across all 4 items is defined as 'moderate' fear of cancer recurrence and a cumulative score of ≥15 is defined as 'high' fear of cancer recurrence.
measure: Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)
time frame: 3 months
description: The HADS is a 14-item assessment tool used to screen for anxiety and depression the general medical population (Zigmond & Snaith, 1983). The HADS is well established tool and has been employed in a multitude of medical settings, including oncology, to assess patients' mental health (Hartung et al., 2017; Vodermaier & Millman, 2011). The HADS assesses two domains, depressionand anxiety. Patients report symptoms of depression and anxiety in the last week on a 4-point Likert scale, from 0 (e.g. "Not at all") to 3 (e.g. "Most of the time").
measure: Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)
time frame: 3 months
description: The EQ-5D is a standardised instrument of health-related quality of life, developed by the EuroQol Group (Herdman et al., 2011). The EQ-5D assesses 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D contains 6-items, 5 of these items assess each of the 5 dimensions and are rated on a 5-level (5L) scale. The final item is a measure of health state, which is rated on a scale of 0 ('worst imaginable health state') to 100 (Best imaginable health state').
measure: Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
time frame: Within 1 month of delivering final intervention
description: Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of breast cancer nurses. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).
measure: Recruitment rate
time frame: Duration of the pilot trial (Approx 2 years)
description: Assess number of patients recruited at each site, including those who decline to participate.
measure: Retention rate
time frame: Duration of the pilot trial (Approx 2 years)
description: Assess number of patients who complete the trial.
measure: Attrition rate
time frame: Duration of the pilot trial (Approx 2 years)
description: Assess number of patients who do not complete the trial, withdraw or drop-out.
measure: Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
time frame: Within 1 month of final follow-up questionnaire
description: Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of patients. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).
arm group label: Intervention group
arm group type: Experimental
description: Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.
arm group label: Control group
arm group type: No Intervention
description: Patients will receive usual care after completion of primary breast cancer treatment.
intervention type: Behavioral
intervention name: Mini-AFTERc
description: Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.
arm group label: Intervention group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gerry M Humphris, PhD
phone: +44 (0) 1334463565
email: gmh4@st-andrews.ac.uk
last name: Calum T McHale, PhD
phone: +44 (0)1334461895
email: ctm2@st-andrews.ac.uk
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Davidson J, Malloch M, Humphris G. A single-session intervention (the Mini-AFTERc) for fear of cancer recurrence: A feasibility study. Psychooncology. 2018 Nov;27(11):2668-2670. doi: 10.1002/pon.4724. Epub 2018 Apr 30. No abstract available.
PMID: 29624779
citation: Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018 Feb 9;16(1):30. doi: 10.1186/s12955-018-0850-x.
PMID: 29471823
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PMID: 6880820
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PMID: 21479777
citation: Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
PMID: 15528286
citation: Cruickshank S, Steel E, Fenlon D, Armes J, Scanlon K, Banks E, Humphris G. A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol. Pilot Feasibility Stud. 2017 Jul 20;4:22. doi: 10.1186/s40814-017-0161-8. eCollection 2018. Erratum In: Pilot Feasibility Stud. 2017 Oct 24;3:48.
PMID: 28748105
citation: Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751.
PMID: 18492319
citation: Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.
PMID: 24160371
citation: Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
PMID: 20961442
citation: Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Mehnert A. The Hospital Anxiety and Depression Scale (HADS) and the 9-item Patient Health Questionnaire (PHQ-9) as screening instruments for depression in patients with cancer. Cancer. 2017 Nov 1;123(21):4236-4243. doi: 10.1002/cncr.30846. Epub 2017 Jun 27.
PMID: 28654189
citation: Vodermaier A, Millman RD. Accuracy of the Hospital Anxiety and Depression Scale as a screening tool in cancer patients: a systematic review and meta-analysis. Support Care Cancer. 2011 Dec;19(12):1899-908. doi: 10.1007/s00520-011-1251-4. Epub 2011 Sep 4.
PMID: 21898134
responsible party type: Principal Investigator
investigator affiliation: University of St Andrews
investigator full name: Prof G Humphris
investigator title: Professor of Health Psychology
mesh term: Breast Neoplasms
mesh term: Recurrence