<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/NCT03000192</url>
  </required_header>
  <id_info>
    <org_study_id>RHM CAN1199</org_study_id>
    <nct_id>NCT03000192</nct_id>
  </id_info>
  <brief_title>HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life</brief_title>
  <official_title>HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to invite all people diagnosed with cancer who meet the&#xD;
      eligibility criteria to complete questionnaires before their treatment begins and at regular&#xD;
      intervals over time to assess the impact of cancer and its treatment on people's lives in the&#xD;
      short, medium and long term. We will explore a range of factors to determine their role in&#xD;
      both recovery of health and well-being and self-management. Although it is known that people&#xD;
      who have had cancer are likely to experience a number of physical and psychological problems&#xD;
      as a result of the disease and treatment, it is not known what the 'typical' course of&#xD;
      recovery of health and well-being looks like, how long it takes and how this can be&#xD;
      influenced. We will determine pathways to recovery of health and well-being following cancer&#xD;
      diagnosis (initially breast cancer diagnosed &lt;50 years, Non-Hodgkin Lymphoma and&#xD;
      gynaecological cancers) and identify what factors influence this. This includes assessing the&#xD;
      relative importance of the person's illness, personal attributes, perceived burden of&#xD;
      treatment, role of the environment they live in, including health / social care and personal&#xD;
      networks of support, and their ability and capacity to self-manage. We will identify who is&#xD;
      most at risk of problems and what environmental supports and resources people are able to&#xD;
      mobilise to support their self-management. We will also explore who has the confidence and&#xD;
      ability to manage during and beyond treatment and what factors influence this and whether&#xD;
      this leads to earlier problem resolution and restoration of health and well-being. This&#xD;
      knowledge will be used to develop and test future supportive interventions to enhance the&#xD;
      rapid recovery of health and well-being - our long term aim being to design ways of helping&#xD;
      people with cancer in areas we identify as problematic for them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life in Adult Cancer Survivors (QLACS)</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>Primary outcome measure which assesses the quality of life in adult cancer survivors. It is comprised of 12 domains regarding cancer survivorship: generic (pain, fatigue, positive and negative feelings, cognitive and sexual problems, social avoidance) and cancer-specific (financial problems, family distress, recurrence distress, appearance concerns, benefits from cancer).&#xD;
Changes will be assessed at the following time-points:&#xD;
Baseline (following diagnosis but pre-treatment)&#xD;
3 months after baseline (to monitor early adaptation and coping)&#xD;
12 months after baseline (to monitor coping and further adaptation)&#xD;
18 months after baseline (to explore early stages of recovery)&#xD;
24 months after baseline and further annual assessments (to monitor consequences in the longer term and how they are managed)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) &amp; Visual Analogue Scale (VAS)</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>Assesses health status for clinical and economic appraisal. Includes five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and five levels of severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC-QLQ-C30</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>Captures the impact of cancer and its treatment with 30 items assessing function (physical, role, cognitive, emotional, and social), symptoms (e.g. fatigue, pain, and nausea and vomiting) as well as global health and QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>Site-specific modules included to capture disease-specific consequences for Breast, Cervical, Endometrial, Ovarian and Vulval cancers, as well as High Grade Non-Hodgkin's Lymphoma (NHL). Modules will be supplemented with additional items from the EORTC item library to assess consequences not otherwise captured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Social Support Survey (MOS-SSS)</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>Assesses the level of social support available and covers 4 domains (emotional/informational, tangible, affectionate support and positive social interaction).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for Managing Chronic Disease (SEMCD) scale &amp; Cancer Survivors' Self-Efficacy Scale (CS-SES)</measure>
    <time_frame>Change from Baseline (pre-treatment) up to 5 years [Anticipated]</time_frame>
    <description>SEMCD evaluates self-efficacy among patients with chronic medical conditions; whilst the CS-SES examines self-efficacy with reference to cancer-specific issues.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Breast Neoplasm</condition>
  <condition>Non-Hodgkin's B-cell Lymphoma</condition>
  <condition>Non-Hodgkin's Lymphoma, Adult High Grade</condition>
  <condition>NonHodgkin Lymphoma</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <condition>Diffuse Large Cell Lymphoma, Adult</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Ovarian Neoplasm</condition>
  <condition>Endometrial Cancer</condition>
  <condition>Endometrial Neoplasms</condition>
  <condition>Cervical Cancer</condition>
  <condition>Cervical Neoplasm</condition>
  <condition>Primary Peritoneal Carcinoma</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Fallopian Tube Neoplasms</condition>
  <condition>Vulvar Cancer</condition>
  <condition>Vulvar Neoplasms</condition>
  <arm_group>
    <arm_group_label>Breast cancer</arm_group_label>
    <description>Women aged &lt;50 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gynaecological cancers</arm_group_label>
    <description>Includes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Hodgkin Lymphoma</arm_group_label>
    <description>Diffuse large B cell</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The aim is to recruit people diagnosed with non-metastatic cancer through their clinical&#xD;
        teams prior to primary treatment. Participants will be identified and recruited from NHS&#xD;
        treatment centres across the UK, with centres chosen from those who express an interest&#xD;
        through the Cancer Research Network (CRN) or directly to the HORIZONS Coordinating Centre.&#xD;
        Centres will be selected for their proven research capability in these cancer types.&#xD;
        Centres will indicate that they can approach a total sample of eligible patients and before&#xD;
        treatment begins. Additionally, Centres will be selected to ensure the Study covers a wide&#xD;
        range of geographical locations across England, Scotland, Wales and Northern Ireland,&#xD;
        ethnically diverse populations and varying-sized hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        OVERALL ELIGIBILITY CRITERIA:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a new diagnosis of one of the selected cancer types determined through clinical&#xD;
             assessment, cytology, histology or imaging or&#xD;
&#xD;
          -  Have new / second primary cancer at a site previously treated for cancer&#xD;
&#xD;
          -  Be awaiting primary curative intent treatment, including neoadjuvant treatment&#xD;
&#xD;
          -  Be ≥16 years old.&#xD;
&#xD;
          -  Be able to complete questionnaires in English&#xD;
&#xD;
          -  Be able to provide written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They do not have one of the specified cancer types&#xD;
&#xD;
          -  Disease is recurrence / progression (either locally advanced or metastatic) at an&#xD;
             existing cancer site&#xD;
&#xD;
          -  They are having treatment for a potentially curative recurrence of disease e.g.&#xD;
             locally advanced disease (i.e. they have been previously treated for the same cancer)&#xD;
&#xD;
          -  They have metastatic disease from a cancer at another site (Previous diagnosis of&#xD;
             cancer at any other site would not be grounds for exclusion unless disease was&#xD;
             metastatic)&#xD;
&#xD;
          -  They have synchronous primary cancers involving two or more of the HORIZONS specified&#xD;
             cancer types (Please exclude synchronous gynaecological primary cancers, synchronous&#xD;
             breast and gynaecological primary cancers, synchronous breast and non-Hodgkin's&#xD;
             lymphoma primary cancers and synchronous non-Hodgkin's lymphoma and gynaecological&#xD;
             cancers)&#xD;
&#xD;
        COHORT-SPECIFIC ELIGIBILITY CRITERIA:&#xD;
&#xD;
        BREAST CANCER COHORT&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          -  Women aged under 50 years old&#xD;
&#xD;
          -  Stage 1, 2 or 3 breast cancer&#xD;
&#xD;
          -  Have no distant metastases&#xD;
&#xD;
          -  Patients due to undergo neoadjuvant treatment should be approached before this starts&#xD;
&#xD;
        For those whose core biopsy shows ductal carcinoma in situ (DCIS) only but post-excision&#xD;
        biopsy pathology confirms invasive cancer, approach should be made as soon as possible&#xD;
        following diagnosis and completion of the baseline questionnaire should be prior to the&#xD;
        start of adjuvant treatment&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Confirmed diagnosis of CIS (ductal or lobular) only&#xD;
&#xD;
          -  Men&#xD;
&#xD;
        NON-HODGKIN LYMPHOMA COHORT&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          -  Any pathological diagnosis of Diffuse Large B Cell lymphoma (DLBCL) including;&#xD;
&#xD;
          -  Secondary transforming or transformed DLBCL which has transformed from an indolent/low&#xD;
             grade lymphoma (most commonly Follicular Lymphoma) as long as the low grade lymphoma&#xD;
             was not treated and this is a recent transformation for which curative intent&#xD;
             treatment has not yet started.&#xD;
&#xD;
          -  Rare sub-types such as T cell rich Large B Cell Lymphoma and primary mediastinal&#xD;
             (thymic) large B-cell lymphoma&#xD;
&#xD;
        Patients who have started steroid pre-phase treatment are eligible for approach before the&#xD;
        start of chemotherapy.&#xD;
&#xD;
        GYNAECOLOGICAL CANCERS COHORT&#xD;
&#xD;
        ALL GYNAECOLOGICAL CANCERS&#xD;
&#xD;
        Gynaecological Cancer Exclusion criteria:&#xD;
&#xD;
        Synchronous gynaecological primary cancers. For example, synchronous ovarian and&#xD;
        endometrial primary cancers.&#xD;
&#xD;
        OVARIAN CANCER SUB-COHORT&#xD;
&#xD;
        Ovarian Inclusion criteria:&#xD;
&#xD;
        Have a confirmed diagnosis either from cytology, histology, imaging or diagnostic primary&#xD;
        surgery of either;&#xD;
&#xD;
          -  Epithelial ovarian cancer including primary peritoneal cancer; fallopian tube cancer&#xD;
&#xD;
          -  Ovarian carcinosarcoma&#xD;
&#xD;
          -  Granulosa tumour of the ovary&#xD;
&#xD;
          -  Patients should be entered prior to any treatment including surgery. However, where&#xD;
             the diagnosis is only made at the time of surgery, these women may enter the study&#xD;
             following surgery. Approach should be made as soon as possible following diagnosis and&#xD;
             completion of the baseline questionnaire should occur prior to the start of adjuvant&#xD;
             treatment.&#xD;
&#xD;
          -  FIGO Stages: IA, IB, IC1, IC2, IC3, IIA, IIB, IIIA1&#xD;
&#xD;
        Ovarian Exclusion criteria:&#xD;
&#xD;
          -  Borderline ovarian cancer&#xD;
&#xD;
          -  Germ cell tumour&#xD;
&#xD;
          -  Sarcoma&#xD;
&#xD;
        ENDOMETRIAL CANCER SUB-COHORT&#xD;
&#xD;
        Endometrial Inclusion criteria:&#xD;
&#xD;
        Have a confirmed diagnosis either from cytology, histology or imaging of;&#xD;
&#xD;
          -  endometrial cancer&#xD;
&#xD;
          -  endometrial carcinosarcoma&#xD;
&#xD;
        Patients should be entered prior to any treatment including surgery. However, where the&#xD;
        diagnosis is only made at the time of surgery, these women may enter the study following&#xD;
        surgery. Approach should be made as soon as possible following diagnosis and completion of&#xD;
        the baseline questionnaire should occur prior to the start of adjuvant treatment.&#xD;
&#xD;
        - International Federation of Gynecology and Obstetrics (FIGO) Stages: IA, IB, II, IIIA,&#xD;
        IIIB, IIIC1, IIIC2&#xD;
&#xD;
        Endometrial Exclusion criteria&#xD;
&#xD;
          -  Choriocarcinoma&#xD;
&#xD;
          -  Germ cell tumour&#xD;
&#xD;
          -  Sarcoma&#xD;
&#xD;
        CERVICAL CANCER SUB-COHORT&#xD;
&#xD;
        Cervical Inclusion criteria:&#xD;
&#xD;
        Have a confirmed diagnosis either from cytology, histology or imaging of;&#xD;
&#xD;
        - Cervical cancer FIGO Stages: IA2, IB1, IB2, IIA1, IIA2, IIB, IIIA, IIIB&#xD;
&#xD;
        Cervical Exclusion criteria:&#xD;
&#xD;
          -  FIGO stage IA1&#xD;
&#xD;
          -  Cervical carcinoma in situ (CIS)&#xD;
&#xD;
          -  Sarcoma&#xD;
&#xD;
          -  Small cell cancer of the cervix&#xD;
&#xD;
        VULVAL CANCER SUB-COHORT&#xD;
&#xD;
        Vulval Inclusion criteria:&#xD;
&#xD;
        Have a confirmed diagnosis either from clinical assessment, cytology, histology, imaging&#xD;
        of;&#xD;
&#xD;
          -  Vulval cancer&#xD;
&#xD;
          -  FIGO stages IA, IB, II, IIIA, IIIB, IIIC&#xD;
&#xD;
        Vulval Exclusion criteria:&#xD;
&#xD;
          -  Basal cell carcinoma&#xD;
&#xD;
          -  Melanoma&#xD;
&#xD;
          -  Sarcoma&#xD;
&#xD;
          -  Vulval intra-epithelial neoplasia (VIN)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bronglais General Hospital</name>
      <address>
        <city>Aberystwyth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monklands Hospital</name>
      <address>
        <city>Airdrie</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antrim Hospital</name>
      <address>
        <city>Antrim</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Harvey Hospital</name>
      <address>
        <city>Ashford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wansbeck General Hospital</name>
      <address>
        <city>Ashington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tameside Hospital</name>
      <address>
        <city>Ashton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ayr</name>
      <address>
        <city>Ayr</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ysbyty Gwynedd</name>
      <address>
        <city>Bangor</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basildon Hospital</name>
      <address>
        <city>Basildon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basingstoke and North Hampshire Hospital</name>
      <address>
        <city>Basingstoke</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bedford Hospital</name>
      <address>
        <city>Bedford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrowe Park Hospital</name>
      <address>
        <city>Birkenhead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clatterbridge Hospital</name>
      <address>
        <city>Birkenhead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham City Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Blackburn Hospital</name>
      <address>
        <city>Blackburn</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pilgrim Hospital</name>
      <address>
        <city>Boston</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Hospital</name>
      <address>
        <city>Bradford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Sussex County Hospital</name>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Infirmary, University Hospital Bristol</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burnley General Teaching Hospital</name>
      <address>
        <city>Burnley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent and Canterbury Hospital</name>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Cumbria University Hospital</name>
      <address>
        <city>Carlisle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epsom &amp; St Helier Hospital</name>
      <address>
        <city>Carshalton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Hospital</name>
      <address>
        <city>Chelsea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colchester General Hospital</name>
      <address>
        <city>Colchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Cosham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northumbria Specialist Emergency Care Hospital</name>
      <address>
        <city>Cramlington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leighton Hospital</name>
      <address>
        <city>Crewe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Manchester General Hospital</name>
      <address>
        <city>Crumpsall</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Darent Valley Hospital</name>
      <address>
        <city>Dartford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Derby Hospital</name>
      <address>
        <city>Derby</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russells Hall Hospital</name>
      <address>
        <city>Dudley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dumfries and Galloway Royal Infirmary</name>
      <address>
        <city>Dumfries</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulster Hospital</name>
      <address>
        <city>Dundonald</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hairmyres Hospital</name>
      <address>
        <city>East Kilbride</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastbourne District General Hospital</name>
      <address>
        <city>Eastbourne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whipps Cross University Hospital</name>
      <address>
        <city>Epping</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Gateshead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medway Maritime Hospital</name>
      <address>
        <city>Gillingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatson West Scotland Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Paget University Hospital</name>
      <address>
        <city>Great Yarmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calderdale Royal Hospital</name>
      <address>
        <city>Halifax</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>Hammersmith</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>Hammersmith</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwick Park Hospital</name>
      <address>
        <city>Harrow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Conquest Hospital</name>
      <address>
        <city>Hastings</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Withybush District General Hospital</name>
      <address>
        <city>Haverfordwest</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Headington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hexham General Hospital</name>
      <address>
        <city>Hexham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillingdon Hospital</name>
      <address>
        <city>Hillingdon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huddersfield Royal Infirmary</name>
      <address>
        <city>Huddersfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raigmore Hospital</name>
      <address>
        <city>Inverness</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ipswich Hospital</name>
      <address>
        <city>Ipswich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Middlesex University Hospital</name>
      <address>
        <city>Isleworth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Crosshouse</name>
      <address>
        <city>Kilmarnock</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>King's Lynn</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James' Hospital</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincoln County Hospital</name>
      <address>
        <city>Lincoln</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St John's Hospital</name>
      <address>
        <city>Livingston</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Llandough</name>
      <address>
        <city>Llandough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Glamorgan Hospital</name>
      <address>
        <city>Llantrisant</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Bartholomew's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macclesfield Hospital</name>
      <address>
        <city>Macclesfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maidstone Hospital</name>
      <address>
        <city>Maidstone</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Hospital</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Hospital</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth the Queen Mother Hospital</name>
      <address>
        <city>Margate</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borders General Hospital</name>
      <address>
        <city>Melrose</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Freeman Hospital</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Tyneside General Hospital</name>
      <address>
        <city>North Shields</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust - City Hospital Campus</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Oldham Hospital</name>
      <address>
        <city>Oldham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterborough City Hospital</name>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Surrey Hospital</name>
      <address>
        <city>Redhill</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ysbyty Glan Clwyd Hospital</name>
      <address>
        <city>Rhyl</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salford Royal</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salisbury District Hospital</name>
      <address>
        <city>Salisbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scarborough Hospital</name>
      <address>
        <city>Scarborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wexham Park Hospital</name>
      <address>
        <city>Slough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ealing Hospital</name>
      <address>
        <city>Southall</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital, University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southend University Hospital</name>
      <address>
        <city>Southend</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Albans City Hospital</name>
      <address>
        <city>St Albans</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's Mill Hospital</name>
      <address>
        <city>Sutton In Ashfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Helier Hospital</name>
      <address>
        <city>Sutton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Hospital (Surrey)</name>
      <address>
        <city>Sutton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Musgrove Park Hospital</name>
      <address>
        <city>Taunton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>Tooting</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Watford General Hospital</name>
      <address>
        <city>Watford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wednesfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandwell General Hospital</name>
      <address>
        <city>West Bromwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weston General Hospital</name>
      <address>
        <city>Weston-super-Mare</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Cumberland Hospital</name>
      <address>
        <city>Whitehaven</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hampshire County Hospital</name>
      <address>
        <city>Winchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Wishaw</name>
      <address>
        <city>Wishaw</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wrexham Maelor Hospital</name>
      <address>
        <city>Wrexham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital</name>
      <address>
        <city>Wythenshawe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Teaching Hospital</name>
      <address>
        <city>York</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Survivorship</keyword>
  <keyword>Cancer</keyword>
  <keyword>Recovery</keyword>
  <keyword>Self-management</keyword>
  <keyword>Cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Vulvar Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We encourage and facilitate data sharing by researchers from all disciplines.&#xD;
More detail can be found on our website: http://horizons-hub.org.uk/access_data.html&#xD;
If you have further questions about this process please contact us on 023 8059 6885 or msrg@soton.ac.uk.</ipd_description>
  </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/NCT03000192
org study id: RHM CAN1199
nct id: NCT03000192
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to invite all people diagnosed with cancer who meet the
      eligibility criteria to complete questionnaires before their treatment begins and at regular
      intervals over time to assess the impact of cancer and its treatment on people's lives in the
      short, medium and long term. We will explore a range of factors to determine their role in
      both recovery of health and well-being and self-management. Although it is known that people
      who have had cancer are likely to experience a number of physical and psychological problems
      as a result of the disease and treatment, it is not known what the 'typical' course of
      recovery of health and well-being looks like, how long it takes and how this can be
      influenced. We will determine pathways to recovery of health and well-being following cancer
      diagnosis (initially breast cancer diagnosed <50 years, Non-Hodgkin Lymphoma and
      gynaecological cancers) and identify what factors influence this. This includes assessing the
      relative importance of the person's illness, personal attributes, perceived burden of
      treatment, role of the environment they live in, including health / social care and personal
      networks of support, and their ability and capacity to self-manage. We will identify who is
      most at risk of problems and what environmental supports and resources people are able to
      mobilise to support their self-management. We will also explore who has the confidence and
      ability to manage during and beyond treatment and what factors influence this and whether
      this leads to earlier problem resolution and restoration of health and well-being. This
      knowledge will be used to develop and test future supportive interventions to enhance the
      rapid recovery of health and well-being - our long term aim being to design ways of helping
      people with cancer in areas we identify as problematic for them.
observational model: Cohort
time perspective: Prospective
measure: Quality of Life in Adult Cancer Survivors (QLACS)
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: Primary outcome measure which assesses the quality of life in adult cancer survivors. It is comprised of 12 domains regarding cancer survivorship: generic (pain, fatigue, positive and negative feelings, cognitive and sexual problems, social avoidance) and cancer-specific (financial problems, family distress, recurrence distress, appearance concerns, benefits from cancer).
Changes will be assessed at the following time-points:
Baseline (following diagnosis but pre-treatment)
3 months after baseline (to monitor early adaptation and coping)
12 months after baseline (to monitor coping and further adaptation)
18 months after baseline (to explore early stages of recovery)
24 months after baseline and further annual assessments (to monitor consequences in the longer term and how they are managed)
measure: EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS)
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: Assesses health status for clinical and economic appraisal. Includes five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and five levels of severity.
measure: EORTC-QLQ-C30
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: Captures the impact of cancer and its treatment with 30 items assessing function (physical, role, cognitive, emotional, and social), symptoms (e.g. fatigue, pain, and nausea and vomiting) as well as global health and QoL.
measure: EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: Site-specific modules included to capture disease-specific consequences for Breast, Cervical, Endometrial, Ovarian and Vulval cancers, as well as High Grade Non-Hodgkin's Lymphoma (NHL). Modules will be supplemented with additional items from the EORTC item library to assess consequences not otherwise captured.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.
measure: Medical Outcomes Study Social Support Survey (MOS-SSS)
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: Assesses the level of social support available and covers 4 domains (emotional/informational, tangible, affectionate support and positive social interaction).
measure: Self-efficacy for Managing Chronic Disease (SEMCD) scale & Cancer Survivors' Self-Efficacy Scale (CS-SES)
time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
description: SEMCD evaluates self-efficacy among patients with chronic medical conditions; whilst the CS-SES examines self-efficacy with reference to cancer-specific issues.
arm group label: Breast cancer
description: Women aged <50 years
arm group label: Gynaecological cancers
description: Includes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer
arm group label: Non-Hodgkin Lymphoma
description: Diffuse large B cell
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
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country: United Kingdom
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Uterine Cervical Neoplasms
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Endometrial Neoplasms
mesh term: Fallopian Tube Neoplasms
mesh term: Breast Neoplasms
mesh term: Vulvar Neoplasms
sharing ipd: Yes
ipd description: We encourage and facilitate data sharing by researchers from all disciplines.
More detail can be found on our website: http://horizons-hub.org.uk/access_data.html
If you have further questions about this process please contact us on 023 8059 6885 or msrg@soton.ac.uk.