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Trial record 36 of 382 for:    Lymphoma AND (women OR woman OR female)

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

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ClinicalTrials.gov Identifier: NCT03000192
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
University of Southampton
Information provided by (Responsible Party):
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.

Condition or disease
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

Study Type : Observational
Estimated 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
Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort
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



Primary Outcome Measures :
  1. Quality of Life in Adult Cancer Survivors (QLACS) [ Time Frame: Change from Baseline (pre-treatment) up to 5 years ]

    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 (to monitor consequences in the longer term and how they are managed)
    • Then 36 months, 48 months, and 60 months after baseline (to monitor consequences, emergence of late effects, co-morbidities, lifestyle change and how they are experienced and managed across the life-course)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The aim is to recruit people diagnosed with non-metastatic cancer through their clinical teams prior to primary treatment. Participants will be identified and recruited from NHS treatment centres across the UK, with centres chosen from those who express an interest through the Cancer Research Network (CRN) or directly to the HORIZONS Coordinating Centre. Centres will be selected for their proven research capability in these cancer types. Centres will indicate that they can approach a total sample of eligible patients and before treatment begins. Additionally, Centres will be selected to ensure the Study covers a wide range of geographical locations across England, Scotland, Wales and Northern Ireland, ethnically diverse populations and varying-sized hospitals.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000192


Contacts
Contact: Richard Brooks Horizons@soton.ac.uk
Contact: Amber Cole Horizons@soton.ac.uk

  Show 87 Study Locations
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
University of Southampton

Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03000192     History of Changes
Other Study ID Numbers: RHM CAN1199
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We encourage and facilitate data sharing by researchers from all disciplines. If you would like more information on how to access the HORIZONS data resource please contact the team at HORIZONS@soton.ac.uk.

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Survivorship
Cancer
Recovery
Self-management
Cohort

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Genital Neoplasms, Female
Genital Diseases, Female
Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Fallopian Tube Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Vulvar Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases
Adnexal Diseases
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases