HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life
HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer
1 other identifier
observational
3,000
1 country
111
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedMarch 17, 2021
March 1, 2021
4.3 years
December 13, 2016
March 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Secondary Outcomes (6)
EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS)
Change from Baseline (pre-treatment) up to 5 years [Anticipated]
EORTC-QLQ-C30
Change from Baseline (pre-treatment) up to 5 years [Anticipated]
EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34
Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Hospital Anxiety and Depression Scale (HADS)
Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Medical Outcomes Study Social Support Survey (MOS-SSS)
Change from Baseline (pre-treatment) up to 5 years [Anticipated]
- +1 more secondary outcomes
Study Arms (3)
Breast cancer
Women aged \<50 years
Gynaecological cancers
Includes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer
Non-Hodgkin Lymphoma
Diffuse large B cell
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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 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:
- BREAST CANCER COHORT
- 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
- Confirmed diagnosis of CIS (ductal or lobular) only
- Men
- NON-HODGKIN LYMPHOMA COHORT
- Any pathological diagnosis of Diffuse Large B Cell lymphoma (DLBCL) including;
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (111)
Bronglais General Hospital
Aberystwyth, United Kingdom
Monklands Hospital
Airdrie, United Kingdom
Antrim Hospital
Antrim, United Kingdom
William Harvey Hospital
Ashford, United Kingdom
Wansbeck General Hospital
Ashington, United Kingdom
Tameside Hospital
Ashton, United Kingdom
University Hospital Ayr
Ayr, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
Basildon Hospital
Basildon, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Royal United Hospital
Bath, United Kingdom
Bedford Hospital
Bedford, United Kingdom
Arrowe Park Hospital
Birkenhead, United Kingdom
Clatterbridge Hospital
Birkenhead, United Kingdom
Birmingham City Hospital
Birmingham, United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Bradford Hospital
Bradford, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Royal Infirmary, University Hospital Bristol
Bristol, United Kingdom
Burnley General Teaching Hospital
Burnley, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
North Cumbria University Hospital
Carlisle, United Kingdom
Epsom & St Helier Hospital
Carshalton, United Kingdom
The Royal Marsden Hospital
Chelsea, United Kingdom
Colchester General Hospital
Colchester, United Kingdom
Queen Alexandra Hospital
Cosham, United Kingdom
Northumbria Specialist Emergency Care Hospital
Cramlington, United Kingdom
Leighton Hospital
Crewe, United Kingdom
North Manchester General Hospital
Crumpsall, United Kingdom
Darent Valley Hospital
Dartford, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Ulster Hospital
Dundonald, United Kingdom
Hairmyres Hospital
East Kilbride, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Whipps Cross University Hospital
Epping, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Beatson West Scotland Cancer Centre
Glasgow, United Kingdom
James Paget University Hospital
Great Yarmouth, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
Calderdale Royal Hospital
Halifax, United Kingdom
Charing Cross Hospital
Hammersmith, United Kingdom
Hammersmith Hospital
Hammersmith, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Conquest Hospital
Hastings, United Kingdom
Withybush District General Hospital
Haverfordwest, United Kingdom
Churchill Hospital
Headington, United Kingdom
Hexham General Hospital
Hexham, United Kingdom
Hillingdon Hospital
Hillingdon, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
West Middlesex University Hospital
Isleworth, United Kingdom
University Hospital Crosshouse
Kilmarnock, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, United Kingdom
St James' Hospital
Leeds, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
St John's Hospital
Livingston, United Kingdom
University Hospital Llandough
Llandough, United Kingdom
Royal Glamorgan Hospital
Llantrisant, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Macclesfield Hospital
Macclesfield, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Saint Mary's Hospital
Manchester, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom
Borders General Hospital
Melrose, United Kingdom
Newcastle Freeman Hospital
Newcastle, United Kingdom
North Tyneside General Hospital
North Shields, United Kingdom
Norwich University Hospital
Norwich, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital Campus
Nottingham, United Kingdom
Royal Oldham Hospital
Oldham, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
East Surrey Hospital
Redhill, United Kingdom
Ysbyty Glan Clwyd Hospital
Rhyl, United Kingdom
Salford Royal
Salford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Scarborough Hospital
Scarborough, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Wexham Park Hospital
Slough, United Kingdom
Ealing Hospital
Southall, United Kingdom
Southampton General Hospital, University Hospital Southampton
Southampton, United Kingdom
Southend University Hospital
Southend, United Kingdom
St Albans City Hospital
St Albans, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
St Helier Hospital
Sutton, United Kingdom
The Royal Marsden Hospital (Surrey)
Sutton, United Kingdom
King's Mill Hospital
Sutton in Ashfield, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
St George's Hospital
Tooting, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Watford General Hospital
Watford, United Kingdom
New Cross Hospital
Wednesfield, United Kingdom
Sandwell General Hospital
West Bromwich, United Kingdom
Weston General Hospital
Weston-super-Mare, United Kingdom
West Cumberland Hospital
Whitehaven, United Kingdom
Royal Hampshire County Hospital
Winchester, United Kingdom
University Hospital Wishaw
Wishaw, United Kingdom
Wrexham Maelor Hospital
Wrexham, United Kingdom
Wythenshawe Hospital
Wythenshawe, United Kingdom
York Teaching Hospital
York, United Kingdom
Related Publications (1)
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.
PMID: 31350251DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 21, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2020
Study Completion
September 1, 2021
Last Updated
March 17, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
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.