HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life
- Conditions
- Breast Cancer FemaleBreast NeoplasmNonHodgkin LymphomaEndometrial CancerEndometrial NeoplasmsDiffuse Large B Cell LymphomaCervical NeoplasmFallopian Tube NeoplasmsNon-Hodgkin's B-cell LymphomaNon-Hodgkin's Lymphoma, Adult High Grade
- Registration Number
- NCT03000192
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life in Adult Cancer Survivors (QLACS) Change from Baseline (pre-treatment) up to 5 years [Anticipated] 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)
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) Change from Baseline (pre-treatment) up to 5 years [Anticipated] Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.
EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS) Change from Baseline (pre-treatment) up to 5 years [Anticipated] 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.
Self-efficacy for Managing Chronic Disease (SEMCD) scale & Cancer Survivors' Self-Efficacy Scale (CS-SES) Change from Baseline (pre-treatment) up to 5 years [Anticipated] SEMCD evaluates self-efficacy among patients with chronic medical conditions; whilst the CS-SES examines self-efficacy with reference to cancer-specific issues.
EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34 Change from Baseline (pre-treatment) up to 5 years [Anticipated] 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.
Medical Outcomes Study Social Support Survey (MOS-SSS) Change from Baseline (pre-treatment) up to 5 years [Anticipated] Assesses the level of social support available and covers 4 domains (emotional/informational, tangible, affectionate support and positive social interaction).
EORTC-QLQ-C30 Change from Baseline (pre-treatment) up to 5 years [Anticipated] 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.
Trial Locations
- Locations (110)
Wansbeck General Hospital
🇬🇧Ashington, United Kingdom
Bronglais General Hospital
🇬🇧Aberystwyth, United Kingdom
Royal United Hospital
🇬🇧Bath, United Kingdom
Tameside Hospital
🇬🇧Ashton, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, United Kingdom
University Hospital Ayr
🇬🇧Ayr, United Kingdom
William Harvey Hospital
🇬🇧Ashford, United Kingdom
Peterborough City Hospital
🇬🇧Peterborough, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital Campus
🇬🇧Nottingham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
East Surrey Hospital
🇬🇧Redhill, United Kingdom
Norwich University Hospital
🇬🇧Norwich, United Kingdom
Salford Royal
🇬🇧Salford, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
St George's Hospital
🇬🇧Tooting, United Kingdom
King's Mill Hospital
🇬🇧Sutton In Ashfield, United Kingdom
University Hospital Wishaw
🇬🇧Wishaw, United Kingdom
Ysbyty Glan Clwyd Hospital
🇬🇧Rhyl, United Kingdom
Wexham Park Hospital
🇬🇧Slough, United Kingdom
St Helier Hospital
🇬🇧Sutton, United Kingdom
Southampton General Hospital, University Hospital Southampton
🇬🇧Southampton, United Kingdom
Southend University Hospital
🇬🇧Southend, United Kingdom
The Royal Marsden Hospital (Surrey)
🇬🇧Sutton, United Kingdom
Watford General Hospital
🇬🇧Watford, United Kingdom
Wythenshawe Hospital
🇬🇧Wythenshawe, United Kingdom
Basildon Hospital
🇬🇧Basildon, United Kingdom
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Bedford Hospital
🇬🇧Bedford, United Kingdom
Arrowe Park Hospital
🇬🇧Birkenhead, United Kingdom
Clatterbridge Hospital
🇬🇧Birkenhead, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, United Kingdom
Hammersmith Hospital
🇬🇧Hammersmith, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Scarborough Hospital
🇬🇧Scarborough, United Kingdom
Ealing Hospital
🇬🇧Southall, United Kingdom
St Albans City Hospital
🇬🇧St Albans, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, 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
Wrexham Maelor Hospital
🇬🇧Wrexham, United Kingdom
York Teaching Hospital
🇬🇧York, United Kingdom
Antrim Hospital
🇬🇧Antrim, United Kingdom
Monklands Hospital
🇬🇧Airdrie, United Kingdom
Birmingham City Hospital
🇬🇧Birmingham, 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
🇬🇧King's Lynn, 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
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
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
Charing Cross Hospital
🇬🇧Hammersmith, United Kingdom