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Breast Cancer FemaleNCT03000192

HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life

An observational study of Breast Cancer Female and Breast Neoplasm, run by University Hospital Southampton NHS Foundation Trust at 111 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
How many people
3,000 participants
Where
111 sitesUnited Kingdom
Study dates
Aug 2016to Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The aim is to recruit people diagnosed with non-metastatic cancer through their clinical teams prior to primary treatment. Participants will be identified and recruited from NHS treatment centres across the UK, with centres chosen from those who express an interest through the Cancer Research Network (CRN) or directly to the HORIZONS Coordinating Centre. Centres will be selected for their proven research capability in these cancer types. Centres will indicate that they can approach a total sample of eligible patients and before treatment begins. Additionally, Centres will be selected to ensure the Study covers a wide range of geographical locations across England, Scotland, Wales and Northern Ireland, ethnically diverse populations and varying-sized hospitals.

Who may be able to join

  • Have a new diagnosis of one of the selected cancer types determined through clinical assessment, cytology, histology or imaging or
  • Have new / second primary cancer at a site previously treated for cancer
  • Be awaiting primary curative intent treatment, including neoadjuvant treatment
  • Be ≥16 years old.
  • Be able to complete questionnaires in English
  • Be able to provide written, informed consent
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  • Women aged under 50 years old
  • Stage 1, 2 or 3 breast cancer
  • Have no distant metastases
  • Patients due to undergo neoadjuvant treatment should be approached before this starts
  • For those whose core biopsy shows ductal carcinoma in situ (DCIS) only but post-excision biopsy pathology confirms invasive cancer, approach should be made as soon as possible following diagnosis and completion of the baseline questionnaire should be prior to the start of adjuvant treatment
  • Any pathological diagnosis of Diffuse Large B Cell lymphoma (DLBCL) including;
  • Secondary transforming or transformed DLBCL which has transformed from an indolent/low grade lymphoma (most commonly Follicular Lymphoma) as long as the low grade lymphoma was not treated and this is a recent transformation for which curative intent treatment has not yet started.
  • Rare sub-types such as T cell rich Large B Cell Lymphoma and primary mediastinal (thymic) large B-cell lymphoma
  • Patients who have started steroid pre-phase treatment are eligible for approach before the start of chemotherapy.
  • GYNAECOLOGICAL CANCERS COHORT
  • ALL GYNAECOLOGICAL CANCERS
  • Gynaecological Cancer Exclusion criteria:
  • Synchronous gynaecological primary cancers. For example, synchronous ovarian and endometrial primary cancers.
  • OVARIAN CANCER SUB-COHORT
  • Ovarian Inclusion criteria:
  • Have a confirmed diagnosis either from cytology, histology, imaging or diagnostic primary surgery of either;
  • Epithelial ovarian cancer including primary peritoneal cancer; fallopian tube cancer
  • Ovarian carcinosarcoma
  • Granulosa tumour of the ovary
  • Patients should be entered prior to any treatment including surgery. However, where the diagnosis is only made at the time of surgery, these women may enter the study following surgery. Approach should be made as soon as possible following diagnosis and completion of the baseline questionnaire should occur prior to the start of adjuvant treatment.
  • FIGO Stages: IA, IB, IC1, IC2, IC3, IIA, IIB, IIIA1
  • Ovarian Exclusion criteria:
  • Borderline ovarian cancer
  • Germ cell tumour
  • Sarcoma
  • ENDOMETRIAL CANCER SUB-COHORT
  • Endometrial Inclusion criteria:
  • Have a confirmed diagnosis either from cytology, histology or imaging of;
  • endometrial cancer
  • endometrial carcinosarcoma
  • Patients should be entered prior to any treatment including surgery. However, where the diagnosis is only made at the time of surgery, these women may enter the study following surgery. Approach should be made as soon as possible following diagnosis and completion of the baseline questionnaire should occur prior to the start of adjuvant treatment.
  • International Federation of Gynecology and Obstetrics (FIGO) Stages: IA, IB, II, IIIA, IIIB, IIIC1, IIIC2
  • Endometrial Exclusion criteria
  • Choriocarcinoma
  • Germ cell tumour
  • Sarcoma
  • CERVICAL CANCER SUB-COHORT
  • Cervical Inclusion criteria:
  • Have a confirmed diagnosis either from cytology, histology or imaging of;
  • Cervical cancer FIGO Stages: IA2, IB1, IB2, IIA1, IIA2, IIB, IIIA, IIIB
  • Cervical Exclusion criteria:
  • FIGO stage IA1
  • Cervical carcinoma in situ (CIS)
  • Sarcoma
  • Small cell cancer of the cervix
  • VULVAL CANCER SUB-COHORT
  • Vulval Inclusion criteria:
  • Have a confirmed diagnosis either from clinical assessment, cytology, histology, imaging of;
  • Vulval cancer
  • FIGO stages IA, IB, II, IIIA, IIIB, IIIC
  • Vulval Exclusion criteria:
  • Basal cell carcinoma
  • Melanoma
  • Sarcoma
  • Vulval intra-epithelial neoplasia (VIN)

Who cannot join

  • They do not have one of the specified cancer types
  • Disease is recurrence / progression (either locally advanced or metastatic) at an existing cancer site
  • They are having treatment for a potentially curative recurrence of disease e.g. locally advanced disease (i.e. they have been previously treated for the same cancer)
  • They have metastatic disease from a cancer at another site (Previous diagnosis of cancer at any other site would not be grounds for exclusion unless disease was metastatic)
  • They have synchronous primary cancers involving two or more of the HORIZONS specified cancer types (Please exclude synchronous gynaecological primary cancers, synchronous breast and gynaecological primary cancers, synchronous breast and non-Hodgkin's lymphoma primary cancers and synchronous non-Hodgkin's lymphoma and gynaecological cancers)
  • COHORT-SPECIFIC ELIGIBILITY CRITERIA:
Show all 10Show fewer
  • BREAST CANCER COHORT
  • Confirmed diagnosis of CIS (ductal or lobular) only
  • Men
  • NON-HODGKIN LYMPHOMA COHORT

Trial locations and contacts

111 sites in 1 country.

111 sites in 1 country

United Kingdom111 sites

  • Bronglais General Hospital

    Aberystwyth

  • Monklands Hospital

    Airdrie

  • Antrim Hospital

    Antrim

  • William Harvey Hospital

    Ashford

  • Wansbeck General Hospital

    Ashington

  • Tameside Hospital

    Ashton

  • University Hospital Ayr

    Ayr

  • Ysbyty Gwynedd

    Bangor

  • Basildon Hospital

    Basildon

  • Basingstoke and North Hampshire Hospital

    Basingstoke

  • Royal United Hospital

    Bath

  • Bedford Hospital

    Bedford

  • Arrowe Park Hospital

    Birkenhead

  • Clatterbridge Hospital

    Birkenhead

  • Birmingham City Hospital

    Birmingham

  • Royal Blackburn Hospital

    Blackburn

  • Pilgrim Hospital

    Boston

  • Bradford Hospital

    Bradford

  • Royal Sussex County Hospital

    Brighton

  • Bristol Royal Infirmary, University Hospital Bristol

    Bristol

  • Burnley General Teaching Hospital

    Burnley

  • Kent and Canterbury Hospital

    Canterbury

  • University Hospital of Wales

    Cardiff

  • North Cumbria University Hospital

    Carlisle

  • Epsom & St Helier Hospital

    Carshalton

  • The Royal Marsden Hospital

    Chelsea

  • Colchester General Hospital

    Colchester

  • Queen Alexandra Hospital

    Cosham

  • Northumbria Specialist Emergency Care Hospital

    Cramlington

  • Leighton Hospital

    Crewe

  • North Manchester General Hospital

    Crumpsall

  • Darent Valley Hospital

    Dartford

  • Royal Derby Hospital

    Derby

  • Russells Hall Hospital

    Dudley

  • Dumfries and Galloway Royal Infirmary

    Dumfries

  • Ninewells Hospital

    Dundee

  • Ulster Hospital

    Dundonald

  • Hairmyres Hospital

    East Kilbride

  • Eastbourne District General Hospital

    Eastbourne

  • Western General Hospital

    Edinburgh

  • Whipps Cross University Hospital

    Epping

  • Queen Elizabeth Hospital

    Gateshead

  • Medway Maritime Hospital

    Gillingham

  • Beatson West Scotland Cancer Centre

    Glasgow

  • James Paget University Hospital

    Great Yarmouth

  • Royal Surrey County Hospital

    Guildford

  • Calderdale Royal Hospital

    Halifax

  • Charing Cross Hospital

    Hammersmith

  • Hammersmith Hospital

    Hammersmith

  • Northwick Park Hospital

    Harrow

  • Conquest Hospital

    Hastings

  • Withybush District General Hospital

    Haverfordwest

  • Churchill Hospital

    Headington

  • Hexham General Hospital

    Hexham

  • Hillingdon Hospital

    Hillingdon

  • Huddersfield Royal Infirmary

    Huddersfield

  • Raigmore Hospital

    Inverness

  • Ipswich Hospital

    Ipswich

  • West Middlesex University Hospital

    Isleworth

  • University Hospital Crosshouse

    Kilmarnock

  • Queen Elizabeth Hospital

    Kings Lynn

  • St James' Hospital

    Leeds

  • Lincoln County Hospital

    Lincoln

  • St John's Hospital

    Livingston

  • University Hospital Llandough

    Llandough

  • Royal Glamorgan Hospital

    Llantrisant

  • St Bartholomew's Hospital

    London

  • University College London Hospital

    London

  • Macclesfield Hospital

    Macclesfield

  • Maidstone Hospital

    Maidstone

  • Manchester Royal Infirmary

    Manchester

  • Saint Mary's Hospital

    Manchester

  • The Christie Hospital

    Manchester

  • Queen Elizabeth the Queen Mother Hospital

    Margate

  • Borders General Hospital

    Melrose

  • Newcastle Freeman Hospital

    Newcastle

  • North Tyneside General Hospital

    North Shields

  • Norwich University Hospital

    Norwich

  • Nottingham University Hospitals NHS Trust - City Hospital Campus

    Nottingham

  • Royal Oldham Hospital

    Oldham

  • Peterborough City Hospital

    Peterborough

  • Derriford Hospital

    Plymouth

  • Royal Preston Hospital

    Preston

  • East Surrey Hospital

    Redhill

  • Ysbyty Glan Clwyd Hospital

    Rhyl

  • Salford Royal

    Salford

  • Salisbury District Hospital

    Salisbury

  • Scarborough Hospital

    Scarborough

  • Royal Hallamshire Hospital

    Sheffield

  • Wexham Park Hospital

    Slough

  • Ealing Hospital

    Southall

  • Southampton General Hospital, University Hospital Southampton

    Southampton

  • Southend University Hospital

    Southend

  • St Albans City Hospital

    St Albans

  • Royal Stoke University Hospital

    Stoke-on-Trent

  • St Helier Hospital

    Sutton

  • The Royal Marsden Hospital (Surrey)

    Sutton

  • King's Mill Hospital

    Sutton in Ashfield

  • Musgrove Park Hospital

    Taunton

  • St George's Hospital

    Tooting

  • Royal Cornwall Hospital

    Truro

  • Watford General Hospital

    Watford

  • New Cross Hospital

    Wednesfield

  • Sandwell General Hospital

    West Bromwich

  • Weston General Hospital

    Weston-super-Mare

  • West Cumberland Hospital

    Whitehaven

  • Royal Hampshire County Hospital

    Winchester

  • University Hospital Wishaw

    Wishaw

  • Wrexham Maelor Hospital

    Wrexham

  • Wythenshawe Hospital

    Wythenshawe

  • York Teaching Hospital

    York

Other trials in United Kingdom

About this study

Official title: HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer

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.

Keywords
Survivorship, Cancer, Recovery, Self-management, Cohort
Medical subject headings
Breast Neoplasms, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03000192
Study groupRoleWhat they receive
Breast cancerWomen aged <50 years
Gynaecological cancersIncludes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer
Non-Hodgkin LymphomaDiffuse large B cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life in Adult Cancer Survivors (QLACS)

    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)

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

Secondary outcomes (6)

  1. EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS)

    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.

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

  2. EORTC-QLQ-C30

    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.

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

  3. EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34

    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.

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

  4. Hospital Anxiety and Depression Scale (HADS)

    Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

  5. Medical Outcomes Study Social Support Survey (MOS-SSS)

    Assesses the level of social support available and covers 4 domains (emotional/informational, tangible, affectionate support and positive social interaction).

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

  6. Self-efficacy for Managing Chronic Disease (SEMCD) scale & Cancer Survivors' Self-Efficacy Scale (CS-SES)

    SEMCD evaluates self-efficacy among patients with chronic medical conditions; whilst the CS-SES examines self-efficacy with reference to cancer-specific issues.

    Measured: Change from Baseline (pre-treatment) up to 5 years [Anticipated]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2020
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03000192
Sponsor's protocol ID
RHM CAN1199
Status last verified
Mar 2021
First submitted
13 Dec 2016
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Foster C, Calman L, Richardson A, May CR, Rogers A, Smith PW. HORIZONS protocol: a UK prospective cohort study to explore recovery of health and well-being in adults diagnosed with cancer. BMJ Open. 2019 Jul 26;9(7):e029662. doi: 10.1136/bmjopen-2019-029662.

    PubMed 31350251

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Female and Breast Neoplasm, run by University Hospital Southampton NHS Foundation Trust at 111 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 61 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life in Adult Cancer Survivors (QLACS) (time frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03000192, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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