HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life (NCT03000192) | Clinical Trial Compass
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HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life
United Kingdom3,000 participantsStarted 2016-08
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Patient…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of Life in Adult Cancer Survivors (QLACS)
Timeframe: Change from Baseline (pre-treatment) up to 5 years [Anticipated]
Trial details
NCT IDNCT03000192
SponsorUniversity Hospital Southampton NHS Foundation Trust