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

Sponsor
University Hospital Southampton NHS Foundation Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03000192
Collaborator
University of Southampton (Other)
3,000
111
61
27
0.4

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bronglais General Hospital Aberystwyth United Kingdom
2 Monklands Hospital Airdrie United Kingdom
3 Antrim Hospital Antrim United Kingdom
4 William Harvey Hospital Ashford United Kingdom
5 Wansbeck General Hospital Ashington United Kingdom
6 Tameside Hospital Ashton United Kingdom
7 University Hospital Ayr Ayr United Kingdom
8 Ysbyty Gwynedd Bangor United Kingdom
9 Basildon Hospital Basildon United Kingdom
10 Basingstoke and North Hampshire Hospital Basingstoke United Kingdom
11 Royal United Hospital Bath United Kingdom
12 Bedford Hospital Bedford United Kingdom
13 Arrowe Park Hospital Birkenhead United Kingdom
14 Clatterbridge Hospital Birkenhead United Kingdom
15 Birmingham City Hospital Birmingham United Kingdom
16 Royal Blackburn Hospital Blackburn United Kingdom
17 Pilgrim Hospital Boston United Kingdom
18 Bradford Hospital Bradford United Kingdom
19 Royal Sussex County Hospital Brighton United Kingdom
20 Bristol Royal Infirmary, University Hospital Bristol Bristol United Kingdom
21 Burnley General Teaching Hospital Burnley United Kingdom
22 Kent and Canterbury Hospital Canterbury United Kingdom
23 University Hospital of Wales Cardiff United Kingdom
24 North Cumbria University Hospital Carlisle United Kingdom
25 Epsom & St Helier Hospital Carshalton United Kingdom
26 The Royal Marsden Hospital Chelsea United Kingdom
27 Colchester General Hospital Colchester United Kingdom
28 Queen Alexandra Hospital Cosham United Kingdom
29 Northumbria Specialist Emergency Care Hospital Cramlington United Kingdom
30 Leighton Hospital Crewe United Kingdom
31 North Manchester General Hospital Crumpsall United Kingdom
32 Darent Valley Hospital Dartford United Kingdom
33 Royal Derby Hospital Derby United Kingdom
34 Russells Hall Hospital Dudley United Kingdom
35 Dumfries and Galloway Royal Infirmary Dumfries United Kingdom
36 Ninewells Hospital Dundee United Kingdom
37 Ulster Hospital Dundonald United Kingdom
38 Hairmyres Hospital East Kilbride United Kingdom
39 Eastbourne District General Hospital Eastbourne United Kingdom
40 Western General Hospital Edinburgh United Kingdom
41 Whipps Cross University Hospital Epping United Kingdom
42 Queen Elizabeth Hospital Gateshead United Kingdom
43 Medway Maritime Hospital Gillingham United Kingdom
44 Beatson West Scotland Cancer Centre Glasgow United Kingdom
45 James Paget University Hospital Great Yarmouth United Kingdom
46 Royal Surrey County Hospital Guildford United Kingdom
47 Calderdale Royal Hospital Halifax United Kingdom
48 Charing Cross Hospital Hammersmith United Kingdom
49 Hammersmith Hospital Hammersmith United Kingdom
50 Northwick Park Hospital Harrow United Kingdom
51 Conquest Hospital Hastings United Kingdom
52 Withybush District General Hospital Haverfordwest United Kingdom
53 Churchill Hospital Headington United Kingdom
54 Hexham General Hospital Hexham United Kingdom
55 Hillingdon Hospital Hillingdon United Kingdom
56 Huddersfield Royal Infirmary Huddersfield United Kingdom
57 Raigmore Hospital Inverness United Kingdom
58 Ipswich Hospital Ipswich United Kingdom
59 West Middlesex University Hospital Isleworth United Kingdom
60 University Hospital Crosshouse Kilmarnock United Kingdom
61 Queen Elizabeth Hospital King's Lynn United Kingdom
62 St James' Hospital Leeds United Kingdom
63 Lincoln County Hospital Lincoln United Kingdom
64 St John's Hospital Livingston United Kingdom
65 University Hospital Llandough Llandough United Kingdom
66 Royal Glamorgan Hospital Llantrisant United Kingdom
67 St Bartholomew's Hospital London United Kingdom
68 University College London Hospital London United Kingdom
69 Macclesfield Hospital Macclesfield United Kingdom
70 Maidstone Hospital Maidstone United Kingdom
71 Manchester Royal Infirmary Manchester United Kingdom
72 Saint Mary's Hospital Manchester United Kingdom
73 The Christie Hospital Manchester United Kingdom
74 Queen Elizabeth the Queen Mother Hospital Margate United Kingdom
75 Borders General Hospital Melrose United Kingdom
76 Newcastle Freeman Hospital Newcastle United Kingdom
77 North Tyneside General Hospital North Shields United Kingdom
78 Norwich University Hospital Norwich United Kingdom
79 Nottingham University Hospitals NHS Trust - City Hospital Campus Nottingham United Kingdom
80 Royal Oldham Hospital Oldham United Kingdom
81 Peterborough City Hospital Peterborough United Kingdom
82 Derriford Hospital Plymouth United Kingdom
83 Royal Preston Hospital Preston United Kingdom
84 East Surrey Hospital Redhill United Kingdom
85 Ysbyty Glan Clwyd Hospital Rhyl United Kingdom
86 Salford Royal Salford United Kingdom
87 Salisbury District Hospital Salisbury United Kingdom
88 Scarborough Hospital Scarborough United Kingdom
89 Royal Hallamshire Hospital Sheffield United Kingdom
90 Wexham Park Hospital Slough United Kingdom
91 Ealing Hospital Southall United Kingdom
92 Southampton General Hospital, University Hospital Southampton Southampton United Kingdom
93 Southend University Hospital Southend United Kingdom
94 St Albans City Hospital St Albans United Kingdom
95 Royal Stoke University Hospital Stoke-on-Trent United Kingdom
96 King's Mill Hospital Sutton In Ashfield United Kingdom
97 St Helier Hospital Sutton United Kingdom
98 The Royal Marsden Hospital (Surrey) Sutton United Kingdom
99 Musgrove Park Hospital Taunton United Kingdom
100 St George's Hospital Tooting United Kingdom
101 Royal Cornwall Hospital Truro United Kingdom
102 Watford General Hospital Watford United Kingdom
103 New Cross Hospital Wednesfield United Kingdom
104 Sandwell General Hospital West Bromwich United Kingdom
105 Weston General Hospital Weston-super-Mare United Kingdom
106 West Cumberland Hospital Whitehaven United Kingdom
107 Royal Hampshire County Hospital Winchester United Kingdom
108 University Hospital Wishaw Wishaw United Kingdom
109 Wrexham Maelor Hospital Wrexham United Kingdom
110 Wythenshawe Hospital Wythenshawe United Kingdom
111 York Teaching Hospital York United Kingdom

Sponsors and Collaborators

  • University Hospital Southampton NHS Foundation Trust
  • University of Southampton

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT03000192
Other Study ID Numbers:
  • RHM CAN1199
First Posted:
Dec 21, 2016
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University Hospital Southampton NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2021