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出境医 / 临床实验 / HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life
HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life
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.
| 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 Design
| 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 |
| Actual Study Start Date : | August 2016 |
| Actual Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | September 2021 |
Arms and Interventions
| Group/Cohort |
|---|
|
Breast cancer
Women aged <50 years
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|
Gynaecological cancers
Includes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer
|
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Non-Hodgkin Lymphoma
Diffuse large B cell
|
Outcome Measures
Primary Outcome Measures :
- Quality of Life in Adult Cancer Survivors (QLACS) [ Time Frame: 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 :
- EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS) [ Time Frame: 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.
- EORTC-QLQ-C30 [ Time Frame: 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.
- EORTC Site Specific Modules: EORTC-QLQ -BR23, -CX24, -EN24, -NHL-HG29, -OV28, VU34 [ Time Frame: 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.
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline (pre-treatment) up to 5 years [Anticipated] ]Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.
- Medical Outcomes Study Social Support Survey (MOS-SSS) [ Time Frame: 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).
- Self-efficacy for Managing Chronic Disease (SEMCD) scale & Cancer Survivors' Self-Efficacy Scale (CS-SES) [ Time Frame: 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
| 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)
Contacts and Locations
Locations
Show 111 study locations
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
University of Southampton
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | December 13, 2016 | ||||
| First Posted Date | December 21, 2016 | ||||
| Last Update Posted Date | March 17, 2021 | ||||
| Actual Study Start Date | August 2016 | ||||
| Actual Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Quality of Life in Adult Cancer Survivors (QLACS) [ Time Frame: 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:
|
||||
| Original Primary Outcome Measures |
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:
|
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| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life | ||||
| Official Title | HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer | ||||
| 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 Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
|
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| Publications * | Foster C, Calman L, Richardson A, May CR, Rogers A, Smith PW. HORIZONS protocol: a UK prospective cohort study to explore recovery of health and well-being in adults diagnosed with cancer. BMJ Open. 2019 Jul 26;9(7):e029662. doi: 10.1136/bmjopen-2019-029662. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment |
3000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | September 2021 | ||||
| Actual Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
OVERALL ELIGIBILITY CRITERIA: Inclusion Criteria:
Exclusion Criteria:
COHORT-SPECIFIC ELIGIBILITY CRITERIA: BREAST CANCER COHORT Inclusion:
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:
NON-HODGKIN LYMPHOMA COHORT Inclusion:
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;
Ovarian Exclusion criteria:
ENDOMETRIAL CANCER SUB-COHORT Endometrial Inclusion criteria: Have a confirmed diagnosis either from cytology, histology or imaging of;
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
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:
VULVAL CANCER SUB-COHORT Vulval Inclusion criteria: Have a confirmed diagnosis either from clinical assessment, cytology, histology, imaging of;
Vulval Exclusion criteria:
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| Sex/Gender |
|
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| Ages | 16 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03000192 | ||||
| Other Study ID Numbers | RHM CAN1199 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | University Hospital Southampton NHS Foundation Trust | ||||
| Study Sponsor | University Hospital Southampton NHS Foundation Trust | ||||
| Collaborators | University of Southampton | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Hospital Southampton NHS Foundation Trust | ||||
| Verification Date | March 2021 | ||||
