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

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer<br>Women aged <50 years | |
| Gynaecological cancers<br>Includes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer | |
| Non-Hodgkin Lymphoma<br>Diffuse large B cell | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 
| 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] | 
| 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] | 
| 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] | 
| 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] | 
| 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survivorship, Cancer, Recovery, Self-management, Cohort