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

• Conditions: Breast Cancer Female; Breast Neoplasm; NonHodgkin Lymphoma; Endometrial Cancer; Endometrial Neoplasms; Diffuse Large B Cell Lymphoma; Cervical Neoplasm; Fallopian Tube Neoplasms; Non-Hodgkin's B-cell Lymphoma; Non-Hodgkin's Lymphoma, Adult High Grade

• Registration Number: NCT03000192
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-21
• Primary Completion: 2020-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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 & 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)

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

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