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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03000192
• Other study ID #: RHM CAN1199
• Status: Active, not recruiting
• Start date: August 2016
• Est. completion date: September 2021

Study information

• Verified date: March 2021
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: September 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasm
• Breast Neoplasms
• Cervical Cancer
• Cervical Neoplasm
• Diffuse Large B Cell Lymphoma
• Diffuse Large Cell Lymphoma, Adult
• Endometrial Cancer
• Endometrial Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Neoplasms
• Non-Hodgkin's B-cell Lymphoma
• Non-Hodgkin's Lymphoma, Adult High Grade
• NonHodgkin Lymphoma
• Ovarian Cancer
• Ovarian Neoplasm
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Uterine Cervical Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Locations

Country	Name	City	State
United Kingdom	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	King's 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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]