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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer; Fallopian Tube Neoplasms; Ovarian Cancer; Fallopian Tube Cancer; Breast Neoplasm; Endometrial Neoplasms; Vulvar Cancer; Vulvar Neoplasms; Endometrial Cancer; Diffuse Large B Cell Lymphoma; Ovarian Neoplasm; Breast Cancer Female; Primary Peritoneal Carcinoma; NonHodgkin Lymphoma; Cervical Neoplasm; Non-Hodgkin's Lymphoma, Adult High Grade; Non-Hodgkin's B-cell Lymphoma; Diffuse Large Cell Lymphoma, Adult

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• United Kingdom
  • Aberystwyth, United Kingdom
    • Bronglais General Hospital
  • Airdrie, United Kingdom
    • Monklands Hospital
  • Antrim, United Kingdom
    • Antrim Hospital
  • Ashford, United Kingdom
    • William Harvey Hospital
  • Ashington, United Kingdom
    • Wansbeck General Hospital
  • Ashton, United Kingdom
    • Tameside Hospital
  • Ayr, United Kingdom
    • University Hospital Ayr
  • Bangor, United Kingdom
    • Ysbyty Gwynedd
  • Basildon, United Kingdom
    • Basildon Hospital
  • Basingstoke, United Kingdom
    • Basingstoke and North Hampshire Hospital
  • Bath, United Kingdom
    • Royal United Hospital
  • Bedford, United Kingdom
    • Bedford Hospital
  • Birkenhead, United Kingdom
    • Arrowe Park Hospital
  • Birkenhead, United Kingdom
    • Clatterbridge Hospital
  • Birmingham, United Kingdom
    • Birmingham City Hospital
  • Blackburn, United Kingdom
    • Royal Blackburn Hospital
  • Boston, United Kingdom
    • Pilgrim Hospital
  • Bradford, United Kingdom
    • Bradford Hospital
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Bristol, United Kingdom
    • Bristol Royal Infirmary, University Hospital Bristol
  • Burnley, United Kingdom
    • Burnley General Teaching Hospital
  • Canterbury, United Kingdom
    • Kent and Canterbury Hospital
  • Cardiff, United Kingdom
    • University Hospital of Wales
  • Carlisle, United Kingdom
    • North Cumbria University Hospital
  • Carshalton, United Kingdom
    • Epsom & St Helier Hospital
  • Chelsea, United Kingdom
    • The Royal Marsden Hospital
  • Colchester, United Kingdom
    • Colchester General Hospital
  • Cosham, United Kingdom
    • Queen Alexandra Hospital
  • Cramlington, United Kingdom
    • Northumbria Specialist Emergency Care Hospital
  • Crewe, United Kingdom
    • Leighton Hospital
  • Crumpsall, United Kingdom
    • North Manchester General Hospital
  • Dartford, United Kingdom
    • Darent Valley Hospital
  • Derby, United Kingdom
    • Royal Derby Hospital
  • Dudley, United Kingdom
    • Russells Hall Hospital
  • Dumfries, United Kingdom
    • Dumfries and Galloway Royal Infirmary
  • Dundee, United Kingdom
    • Ninewells Hospital
  • Dundonald, United Kingdom
    • Ulster Hospital
  • East Kilbride, United Kingdom
    • Hairmyres Hospital
  • Eastbourne, United Kingdom
    • Eastbourne District General Hospital
  • Edinburgh, United Kingdom
    • Western General Hospital
  • Epping, United Kingdom
    • Whipps Cross University Hospital
  • Gateshead, United Kingdom
    • Queen Elizabeth Hospital
  • Gillingham, United Kingdom
    • Medway Maritime Hospital
  • Glasgow, United Kingdom
    • Beatson West Scotland Cancer Centre
  • Great Yarmouth, United Kingdom
    • James Paget University Hospital
  • Guildford, United Kingdom
    • Royal Surrey County Hospital
  • Halifax, United Kingdom
    • Calderdale Royal Hospital
  • Hammersmith, United Kingdom
    • Charing Cross Hospital
  • Hammersmith, United Kingdom
    • Hammersmith Hospital
  • Harrow, United Kingdom
    • Northwick Park Hospital
  • Hastings, United Kingdom
    • Conquest Hospital
  • Haverfordwest, United Kingdom
    • Withybush District General Hospital
  • Headington, United Kingdom
    • Churchill Hospital
  • Hexham, United Kingdom
    • Hexham General Hospital
  • Hillingdon, United Kingdom
    • Hillingdon Hospital
  • Huddersfield, United Kingdom
    • Huddersfield Royal Infirmary
  • Inverness, United Kingdom
    • Raigmore Hospital
  • Ipswich, United Kingdom
    • Ipswich Hospital
  • Isleworth, United Kingdom
    • West Middlesex University Hospital
  • Kilmarnock, United Kingdom
    • University Hospital Crosshouse
  • King's Lynn, United Kingdom
    • Queen Elizabeth Hospital
  • Leeds, United Kingdom
    • St James' Hospital
  • Lincoln, United Kingdom
    • Lincoln County Hospital
  • Livingston, United Kingdom
    • St John's Hospital
  • Llandough, United Kingdom
    • University Hospital Llandough
  • Llantrisant, United Kingdom
    • Royal Glamorgan Hospital
  • London, United Kingdom
    • University College London Hospital
  • London, United Kingdom
    • St Bartholomew's Hospital
  • Macclesfield, United Kingdom
    • Macclesfield Hospital
  • Maidstone, United Kingdom
    • Maidstone Hospital
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
  • Manchester, United Kingdom
    • The Christie Hospital
  • Manchester, United Kingdom
    • Saint Mary's Hospital
  • Margate, United Kingdom
    • Queen Elizabeth the Queen Mother Hospital
  • Melrose, United Kingdom
    • Borders General Hospital
  • Newcastle, United Kingdom
    • Newcastle Freeman Hospital
  • North Shields, United Kingdom
    • North Tyneside General Hospital
  • Norwich, United Kingdom
    • Norwich University Hospital
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust - City Hospital campus
  • Oldham, United Kingdom
    • Royal Oldham Hospital
  • Peterborough, United Kingdom
    • Peterborough City Hospital
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Preston, United Kingdom
    • Royal Preston Hospital
  • Redhill, United Kingdom
    • East Surrey Hospital
  • Rhyl, United Kingdom
    • Ysbyty Glan Clwyd Hospital
  • Salford, United Kingdom
    • Salford Royal
  • Salisbury, United Kingdom
    • Salisbury District Hospital
  • Scarborough, United Kingdom
    • Scarborough Hospital
  • Sheffield, United Kingdom
    • Royal Hallamshire Hospital
  • Slough, United Kingdom
    • Wexham Park Hospital
  • Southall, United Kingdom
    • Ealing Hospital
  • Southampton, United Kingdom
    • Southampton General Hospital, University Hospital Southampton
  • Southend, United Kingdom
    • Southend University Hospital
  • St Albans, United Kingdom
    • St Albans City Hospital
  • Stoke-on-Trent, United Kingdom
    • Royal Stoke University Hospital
  • Sutton, United Kingdom
    • St Helier Hospital
  • Sutton, United Kingdom
    • The Royal Marsden Hospital (Surrey)
  • Sutton In Ashfield, United Kingdom
    • King's Mill Hospital
  • Taunton, United Kingdom
    • Musgrove Park Hospital
  • Tooting, United Kingdom
    • St George's Hospital
  • Truro, United Kingdom
    • Royal Cornwall Hospital
  • Watford, United Kingdom
    • Watford General Hospital
  • Wednesfield, United Kingdom
    • New Cross Hospital
  • West Bromwich, United Kingdom
    • Sandwell General Hospital
  • Weston-super-Mare, United Kingdom
    • Weston General Hospital
  • Whitehaven, United Kingdom
    • West Cumberland Hospital
  • Winchester, United Kingdom
    • Royal Hampshire County Hospital
  • Wishaw, United Kingdom
    • University Hospital Wishaw
  • Wrexham, United Kingdom
    • Wrexham Maelor Hospital
  • Wythenshawe, United Kingdom
    • Wythenshawe Hospital
  • York, United Kingdom
    • York Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

OVERALL ELIGIBILITY CRITERIA:

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

BREAST CANCER COHORT

Inclusion:

• 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

Exclusion:

• Confirmed diagnosis of CIS (ductal or lobular) only
• Men

NON-HODGKIN LYMPHOMA COHORT

Inclusion:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline (pre-treatment) up to 5 years [Anticipated]
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.	Change from Baseline (pre-treatment) up to 5 years [Anticipated]
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.	Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Hospital Anxiety and Depression Scale (HADS)	Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.	Change from Baseline (pre-treatment) up to 5 years [Anticipated]
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).	Change from Baseline (pre-treatment) up to 5 years [Anticipated]
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.	Change from Baseline (pre-treatment) up to 5 years [Anticipated]

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: University of Southampton

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Recovery; Cohort; Self-management; Survivorship
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Fallopian Tube Diseases; Vulvar Diseases; Neoplasms; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Uterine Cervical Neoplasms; Breast Neoplasms; Lymphoma, Non-Hodgkin; Ovarian Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms; Vulvar Neoplasms
• Other Study ID Numbers: RHM CAN1199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan 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.