Clinical trial NCT03000192: HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life
Official title: HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Breast Neoplasm
Non-Hodgkin's B-cell Lymphoma
Non-Hodgkin's Lymphoma, Adult High Grade
NonHodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Diffuse Large Cell Lymphoma, Adult
Ovarian Cancer
Ovarian Neoplasm
Endometrial Cancer
Endometrial Neoplasms
Cervical Cancer
Cervical Neoplasm
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Fallopian Tube Neoplasms
Vulvar Cancer
Vulvar Neoplasms
Keywords: Survivorship
Cancer
Recovery
Self-management
Cohort
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Southampton
First posted: 2016-12-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Life in Adult Cancer Survivors (QLACS)
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Secondary outcomes:
measure: EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS)
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
measure: EORTC-QLQ-C30
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
measure: EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
measure: Medical Outcomes Study Social Support Survey (MOS-SSS)
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
measure: Self-efficacy for Managing Chronic Disease (SEMCD) scale & Cancer Survivors' Self-Efficacy Scale (CS-SES)
timeFrame: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Other outcomes:
Locations:
city: Aberystwyth
country: United Kingdom
facility: Bronglais General Hospital
city: Airdrie
country: United Kingdom
facility: Monklands Hospital
city: Antrim
country: United Kingdom
facility: Antrim Hospital
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
city: Ashton
country: United Kingdom
facility: Tameside Hospital
city: Ayr
country: United Kingdom
facility: University Hospital Ayr
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
city: Basildon
country: United Kingdom
facility: Basildon Hospital
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Bedford
country: United Kingdom
facility: Bedford Hospital
city: Birkenhead
country: United Kingdom
facility: Arrowe Park Hospital
city: Birkenhead
country: United Kingdom
facility: Clatterbridge Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham City Hospital
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: Bradford
country: United Kingdom
facility: Bradford Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary, University Hospital Bristol
city: Burnley
country: United Kingdom
facility: Burnley General Teaching Hospital
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Carlisle
country: United Kingdom
facility: North Cumbria University Hospital
city: Carshalton
country: United Kingdom
facility: Epsom & St Helier Hospital
city: Chelsea
country: United Kingdom
facility: The Royal Marsden Hospital
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
city: Cosham
country: United Kingdom
facility: Queen Alexandra Hospital
city: Cramlington
country: United Kingdom
facility: Northumbria Specialist Emergency Care Hospital
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: Crumpsall
country: United Kingdom
facility: North Manchester General Hospital
city: Dartford
country: United Kingdom
facility: Darent Valley Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Dumfries
country: United Kingdom
facility: Dumfries and Galloway Royal Infirmary
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Dundonald
country: United Kingdom
facility: Ulster Hospital
city: East Kilbride
country: United Kingdom
facility: Hairmyres Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Epping
country: United Kingdom
facility: Whipps Cross University Hospital
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West Scotland Cancer Centre
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Halifax
country: United Kingdom
facility: Calderdale Royal Hospital
city: Hammersmith
country: United Kingdom
facility: Charing Cross Hospital
city: Hammersmith
country: United Kingdom
facility: Hammersmith Hospital
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Hastings
country: United Kingdom
facility: Conquest Hospital
city: Haverfordwest
country: United Kingdom
facility: Withybush District General Hospital
city: Headington
country: United Kingdom
facility: Churchill Hospital
city: Hexham
country: United Kingdom
facility: Hexham General Hospital
city: Hillingdon
country: United Kingdom
facility: Hillingdon Hospital
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: Kilmarnock
country: United Kingdom
facility: University Hospital Crosshouse
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: St James' Hospital
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: Livingston
country: United Kingdom
facility: St John's Hospital
city: Llandough
country: United Kingdom
facility: University Hospital Llandough
city: Llantrisant
country: United Kingdom
facility: Royal Glamorgan Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Macclesfield
country: United Kingdom
facility: Macclesfield Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Saint Mary's Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
city: Melrose
country: United Kingdom
facility: Borders General Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle Freeman Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Norwich
country: United Kingdom
facility: Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - City Hospital Campus
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
city: Rhyl
country: United Kingdom
facility: Ysbyty Glan Clwyd Hospital
city: Salford
country: United Kingdom
facility: Salford Royal
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Scarborough
country: United Kingdom
facility: Scarborough Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Slough
country: United Kingdom
facility: Wexham Park Hospital
city: Southall
country: United Kingdom
facility: Ealing Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital, University Hospital Southampton
city: Southend
country: United Kingdom
facility: Southend University Hospital
city: St Albans
country: United Kingdom
facility: St Albans City Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Sutton In Ashfield
country: United Kingdom
facility: King's Mill Hospital
city: Sutton
country: United Kingdom
facility: St Helier Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital (Surrey)
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Tooting
country: United Kingdom
facility: St George's Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Watford
country: United Kingdom
facility: Watford General Hospital
city: Wednesfield
country: United Kingdom
facility: New Cross Hospital
city: West Bromwich
country: United Kingdom
facility: Sandwell General Hospital
city: Weston-super-Mare
country: United Kingdom
facility: Weston General Hospital
city: Whitehaven
country: United Kingdom
facility: West Cumberland Hospital
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital
city: Wishaw
country: United Kingdom
facility: University Hospital Wishaw
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital
city: York
country: United Kingdom
facility: York Teaching Hospital
Study officials:
References:
citation: 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.