Bridging the age gap in breast cancer
| ISRCTN | ISRCTN46099296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46099296 |
| EudraCT/CTIS number | 2016-000779-25 |
| Secondary identifying numbers | DBH 0530/2013/NCT |
- Submission date
- 11/08/2016
- Registration date
- 11/11/2016
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Current plain English summary as of 15/10/2018:
Background and study aims
Breast cancer is common in older women, affecting 13,000 women in the UK over the age of 70 every year. Despite this, little has been done to study breast cancer in older women to find out the best way to treat this disease and what types of treatment older women prefer. For many older women, treatment is identical to that of younger women as they have comparable levels of health and fitness. Surgery followed by a range of treatments is recommended and often tolerated well. However, for some older women, treatment may need to be changed to take into account other illnesses and frailty which may limit their ability to tolerate the full range of treatments. The problem is that there is little guidance available on this level of age, ill health and frailty, which makes the risks of some treatments (such as surgery and chemotherapy) outweigh the benefits. At present, these decisions are based on the personal expertise of the treating team with no research to guide them to best practice. This has resulted in a high level of variation in practice in the UK. This study hopes to fill this gap in our knowledge by studying UK practice and treatment in older women.
Who can participate?
Women aged over 70 years with breast cancer
What does the study involve?
The study involves collecting detailed data about how fit older women are at the start of their treatment (other illnesses, level of independence, and quality of life), how they respond to their recommended treatment, and finally, how well their cancer is controlled in the long term. This study has a minimal impact on them and involves completing some questionnaires (some of which are optional). The study will then evaluate the use of decision support interventions (DESIs), which are given to 50% of sites and embedded as ‘standard of care.’ The DESIs comprise two patient-facing booklets and two web-based tools, which can be shared with individual patients. Women can take part in one of the following three ways. In its simplest form, the study only requires the participants’ permission to collect data about them, with no requirement to complete any questionnaires. The research staff just need permission to access the notes to obtain as much data as they can or ask carers for information if they have cognitive decline. Some women may be happy to spend a little time going through some initial questions about their health, fitness and independence on their first visit, but may not wish to fill in any further detailed quality-of-life questionnaires at follow-up visits. Some women may be happy to also fill in quality of life questionnaires at their first visit and when they attend follow-up visits.
What are the possible benefits and risks of participating?
This study will not directly benefit participants, but will give a much better understanding of the best ways to treat breast cancer in older women, and also help clinicians themselves to make better choices about treatment. The study is very low risk and involves no change of treatment. The study is designed to pose a minimal burden to participants, meaning that many parts are either optional or can be done later via telephone or postal return of quality of life questionnaires.
Where is the study run from?
Doncaster and Bassetlaw Hospitals NHS Foundation Trust and 48 other trusts in the UK
When is the study starting and how long is it expected to run for?
July 2012 to May 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Charlene Martin, agegap@sheffield.ac.uk
Previous plain English summary:
Background and study aims
Breast cancer is common in older women, affecting 13,000 women in the UK over the age of 70 every year. Despite this, little has been done to study breast cancer in older women to find out the best way to treat this disease and what types of treatment older women prefer. For many older women, treatment is identical to that of younger women as they have comparable levels of health and fitness. Surgery followed by a range of treatments is recommended and often tolerated well. However, for some older women, treatment may need to be changed to take into account other illnesses and frailty which may limit their ability to tolerate the full range of treatments. The problem is that there is little guidance available on this level of age, ill health and frailty, which makes the risks of some treatments (such as surgery and chemotherapy) outweigh the benefits. At present, these decisions are based on the personal expertise of the treating team with no research to guide them to best practice. This has resulted in a high level of variation in practice in the UK. This study hopes to fill this gap in our knowledge by studying UK practice and treatment in older women.
Who can participate?
Women aged over 70 years with breast cancer
What does the study involve?
The study involves collecting detailed data about how fit older women are at the start of their treatment (other illnesses, level of independence, and quality of life), how they respond to their recommended treatment, and finally, how well their cancer is controlled in the long term. This study has a minimal impact on them and involves completing some questionnaires (some of which are optional). Women can take part in one of the following three ways. In its simplest form, the study only requires the participants’ permission to collect data about them, with no requirement to complete any questionnaires. The research staff just need permission to access the notes to obtain as much data as they can or ask carers for information if they have cognitive decline. Some women may be happy to spend a little time going through some initial questions about their health, fitness and independence on their first visit, but may not wish to fill in any further detailed quality-of-life questionnaires at follow-up visits. Some women may be happy to also fill in quality of life questionnaires at their first visit and when they attend follow-up visits.
What are the possible benefits and risks of participating?
This study will not directly benefit participants, but will give a much better understanding of the best ways to treat breast cancer in older women, and also help clinicians themselves to make better choices about treatment. The study is very low risk and involves no change of treatment. The study is designed to pose a minimal burden to participants, meaning that many parts are either optional or can be done later via telephone or postal return of quality of life questionnaires.
Where is the study run from?
Doncaster and Bassetlaw Hospitals NHS Foundation Trust and 48 other trusts in the UK
When is the study starting and how long is it expected to run for?
July 2012 to October 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Charlene Martin
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-improving-outcomes-older-women-breast-cancer
Contact information
Public
FU21, Department of Oncology and Metabolism
University of Sheffield Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
Study information
| Study design | Observational cohort study with nested cluster randomized controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.sheffield.ac.uk/polopoly_fs/1.597185!/file/Patient_Information_Sheet_Version_5_9th_March_2016.docx |
| Scientific title | Bridging the age gap in breast cancer: improving outcomes for older women |
| Study objectives | Current hypothesis as of 15/10/2018: The Age Gap study will use state of the art statistical and modelling techniques to determine the age, comorbidity, frailty and disease characteristics of women over 70 with early breast cancer to provide guidance on two primary questions: 1. What are the personal and cancer characteristics of women who can be safely advised that surgery is unlikely to confer any advantage for them? 2. What are the personal and cancer characteristics of women who should be advised to have adjuvant chemotherapy after surgery? These data will be used to provide guidelines for clinicians to ensure that optimal individually tailored treatment is offered to all older women with breast cancer. The data from the cohort study will then be used to develop two management algorithms for older women with breast cancer using a package of decision support interventions (DESIs) nested in the cohort study. Previous hypothesis: The Age Gap study will use state of the art statistical and modelling techniques to determine the age, comorbidity, frailty and disease characteristics of women over 70 with early breast cancer to provide guidance on two primary questions: 1. What are the personal and cancer characteristics of women who can be safely advised that surgery is unlikely to confer any advantage for them? 2. What are the personal and cancer characteristics of women who should be advised to have adjuvant chemotherapy after surgery? These data will be used to provide guidelines for clinicians to ensure that optimal individually tailored treatment is offered to all older women with breast cancer. |
| Ethics approval(s) | London South East Research Ethics Committee, 30/11/2012 (revised 25/01/2013), ref: 12/LO/1808 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Current intervention as of 15/10/2018: Phase One: The first phase is to construct a preliminary disease outcome and health economic model of breast cancer in older women. This will be based on the rather limited published trial evidence in this age group and also retrospective data from the UK cancer registry and hospital episode statistics (HES data). Once the participant has consented, the treatment they have decided to have will just proceed as normal, with no change. Information about how the participant is doing and the treatment they are receiving will be recorded by a member of study staff but the participant's hospital visit will not differ from normal with the exception of going through some questionnaires with a member of the study team about their health, fitness and independence. Health and fitness data will be collected using well validated tools widely used in the field of geriatric research (the IADL, ADL, MMSE, Charlson score etc). These questionnaires are only completed at the baseline visit and if the woman wishes, she may complete these at a later date via a telephone call to minimise the burden of the study at each visit. It is estimated that these baseline questionnaires will take 20 to 30 minutes. The participant can opt to also take part in answering questionnaires about how they are feeling (quality of life validated questionnaires: the EORTC QLQ C30, BR23 and ELD 15) at baseline and when they attend for their follow up visits. These are all well validated, widely used instruments in health research and are easy to understand and administer. The participant can see the questionnaires before they decide whether they want to take part so they can see what sort of questions they are. If the participant agrees to this option, these questionnaires will be completed pre-treatment and at various follow-up visits. Again, these may be completed later either by the patient themselves (and posted back to the study centre) or via a telephone call. The participant can also opt to agree to let the study team have potential future access to any biopsy samples of their breast cancer that may have already been taken as part of their normal care. No additional biopsies for the study will be taken. These samples will not be accessed as part of the present study but the consents may be used as the basis for a follow on biological markers study which will be the subject of further funding and ethics applications. The participant also has the option of agreeing to let the research team follow their long-term progress, even after the clinic has discharged them by giving consent for the study team to have access to their cancer registry and HES data. Follow up by this means would be undertaken for 10 years. The participant will be seen in the clinic 6 weeks after they started their treatment and then every 6 months after they entered the study for a minimum of 2 years and up to 5 years. At each visit their doctor will perform a routine physical examination to check that their disease is under control and that they are well, the participant will also be asked if they have had any treatment-related problems. If the participant has agreed to full participation, at some of these visits the participant will also be asked by their doctor/nurse to complete some questionnaires about their quality of life. Patients may complete these questionnaires at home after their clinic visit if they wish. At follow-up visits, patients on Primary Endocrine Therapy will have the size of the primary tumour and the largest of the diseased axillary lymph nodes (if present) measured by the Consultant Breast Surgeon, Consultant Oncologist or an appropriate delegated individual. These assessments are all part of normal routine practice. At follow-up visits all patients will have the following documented: 1. Treatment details will be recorded e.g. radiotherapy, surgery, chemotherapy, trastuzumab, endocrine therapy 2. Treatment-related adverse events 3. Management of local/regional recurrence, progressive disease, metastatic disease or new primary breast tumour (if applicable) The data from the cohort study will then be used to modify and improve the preliminary model of cancer outcomes and enable us to develop two management algorithms for older women with breast cancer using a package of decision support interventions (DESIs). Phase Two: The DESIs will be embedded in half of Age Gap recruiting sites as part of standard care, with completion of two additional questionnaires focusing on pre-treatment counselling and decision-making, and the ability to use the decision aids if they wish to help patients decide on treatment. The aim of the intervention is to improve the quality of life, decision quality, decision regret, satisfaction and treatment understanding of older women entering the Age Gap study. These DESIs will be aimed at women facing a choice of surgery or primary endocrine therapy (PET) or, following surgery, for those with higher risk cancer facing a choice of chemotherapy or no chemotherapy. These are the two areas where clinical practice in older women differs most markedly from that in younger women and where there are high levels of variation between breast units. The DESIs comprise of two patient facing booklets designed especially for older women facing these choices and two web based algorithms, which may be used by the clinical team to predict individual risk and benefit information that can be shared with patients. These resources have been carefully developed using the best available evidence and have undergone extensive user testing. Sites will be allocated access to use the decision tools as part of routine care or simply continue with normal best practice pre-treatment counselling. Randomisation of sites will be stratified according to PET and chemotherapy rate. 1. Control – Usual standard practice for older women (>70 years) diagnosed with breast cancer with no change to normal counselling and decision-making practice. 2. Intervention – Usual standard practice for older women (>70 years) diagnosed with breast cancer plus optional clinician and patient access to the DESIs (option grid, detailed information booklet and clinical algorithm), which will have been made available to these units to adopt as their standard of care. Previous intervention: The first phase is to construct a preliminary disease outcome and health economic model of breast cancer in older women. This will be based on the rather limited published trial evidence in this age group and also retrospective data from the UK cancer registry and hospital episode statistics (HES data). Once the participant has consented, the treatment they have decided to have will just proceed as normal, with no change. Information about how the participant is doing and the treatment they are receiving will be recorded by a member of study staff but the participant's hospital visit will not differ from normal with the exception of going through some questionnaires with a member of the study team about their health, fitness and independence. Health and fitness data will be collected using well validated tools widely used in the field of geriatric research (the IADL, ADL, MMSE, Charlson score etc). These questionnaires are only completed at the baseline visit and if the woman wishes, she may complete these at a later date via a telephone call to minimise the burden of the study at each visit. It is estimated that these baseline questionnaires will take 20 to 30 minutes. The participant can opt to also take part in answering questionnaires about how they are feeling (quality of life validated questionnaires: the EORTC QLQ C30, BR23 and ELD 15) at baseline and when they attend for their follow up visits. These are all well validated, widely used instruments in health research and are easy to understand and administer. The participant can see the questionnaires before they decide whether they want to take part so they can see what sort of questions they are. If the participant agrees to this option, these questionnaires will be completed pre-treatment and at various follow-up visits. Again, these may be completed later either by the patient themselves (and posted back to the study centre) or via a telephone call. The participant can also opt to agree to let the study team have potential future access to any biopsy samples of their breast cancer that may have already been taken as part of their normal care. No additional biopsies for the study will be taken. These samples will not be accessed as part of the present study but the consents may be used as the basis for a follow on biological markers study which will be the subject of further funding and ethics applications. The participant also has the option of agreeing to let the research team follow their long-term progress, even after the clinic has discharged them by giving consent for the study team to have access to their cancer registry and HES data. Follow up by this means would be undertaken for 10 years. The participant will be seen in the clinic 6 weeks after they started their treatment and then every 6 months after they entered the study for a minimum of 2 years and up to 5 years. At each visit their doctor will perform a routine physical examination to check that their disease is under control and that they are well, the participant will also be asked if they have had any treatment-related problems. If the participant has agreed to full participation, at some of these visits the participant will also be asked by their doctor/nurse to complete some questionnaires about their quality of life. Patients may complete these questionnaires at home after their clinic visit if they wish. At follow-up visits, patients on Primary Endocrine Therapy will have the size of the primary tumour and the largest of the diseased axillary lymph nodes (if present) measured by the Consultant Breast Surgeon, Consultant Oncologist or an appropriate delegated individual. These assessments are all part of normal routine practice. At follow-up visits all patients will have the following documented: 1. Treatment details will be recorded e.g. radiotherapy, surgery, chemotherapy, trastuzumab, endocrine therapy 2. Treatment-related adverse events 3. Management of local/regional recurrence, progressive disease, metastatic disease or new primary breast tumour (if applicable) The data from the cohort study will then be used to modify and improve the preliminary model of cancer outcomes and enable us to develop two management algorithms for older women with breast cancer. These will be made freely available as web-based tools to help to guide clinicians in optimising the management of older women. |
| Intervention type | Other |
| Primary outcome measure | Global health status/quality of life, measured using questions 29+30 of The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at 6 weeks and 6 months post-intervention |
| Secondary outcome measures | Current secondary outcome measures as of 15/10/2018: Measured at the time of diagnosis: 1. Comorbidity, measured using the Charlson comorbidity index 2. Frailty, measured using the Barthel Index (ADL) and instrumental activities of daily living scores (IADL) 3. Cognitive status, measured using the mini-mental state examination MMSE) 4. Quality of life, measured using the EORTC QLQ C30, EORTC breast cancer-specific quality-of-life questionnaire (BR23), EORTC quality of life questionnaire module for older people with cancer (EORTC ELD 15, EuroQol Group EQ-5D) 5. Tumour stage, grade and receptor status 6. Decision regret, measured using the Decision Regret Scale 7. Shared decision making using the CollaboRATE score 8. Patient anxiety levels using the Speilberger short-form State Anxiety Score 9. Knowledge and treatment preference, measured using a non-validated questionnaire 10. Illness perceptions after the relevant treatment decision using the Brief Illness Perceptions Questionnaire 11. Coping after the relevant treatment decision, using the Brief COPE Previous secondary outcome measures: Measured at the time of diagnosis: 1. Comorbidity, measured using the Charlson comorbidity index 2. Frailty, measured using the Barthel Index (ADL) and instrumental activities of daily living scores (IADL) 3. Cognitive status, measured using the mini-mental state examination MMSE) 4. Quality of life, measured using the EORTC QLQ C30, EORTC breast cancer-specific quality-of-life questionnaire (BR23), EORTC quality of life questionnaire module for older people with cancer (EORTC ELD 15, EuroQol Group EQ-5D) 5. Tumour stage, grade and receptor status |
| Overall study start date | 01/07/2012 |
| Completion date | 30/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 70 Years |
| Sex | Female |
| Target number of participants | 3000 |
| Total final enrolment | 3416 |
| Key inclusion criteria | Current inclusion criteria as of 15/10/2018: 1. Female 2. Aged over 70 years of age at the time of diagnosis of cancer 3. Primary operable (TNM categories: T1 (Tumour 2 cm or less in greatest dimension), T2 (Tumour more than 2 cm but not more than 5 cm in greatest dimension), T3 (Tumour more than 5 cm in greatest dimension), N0 (No regional lymph node metastasis), N1 (Metastasis in movable ipsilateral axillary lymph node(s), M0 (No distant metastasis)) invasive breast cancer (core biopsy or diagnostic incision biopsy) 4. Tumour ER and Her-2 status will be available and categorised according to accepted scoring systems e.g. H score 6 or Allred score 57 for ER and for Her-2, IHC score 1-3 plus FISH testing if IHC equivocal 5. Ability to give informed consent if considering full or partial trial participation (see below) 6. Willing to complete the questionnaires for the additional trial evaluations if considering full trial participation 7. If suitable for data collection only, the patient does not need to give consent but participation in the data collection exercise should be agreed and assented to by their next of kin, friend or carer 8. Willing to complete the additional questionnaires for the additional trial evaluations relating to decision-making quality, regret and knowledge. All women in the study who are offered a choice of treatments will have the decision quality forms sent to them in both intervention and control sites at baseline, 6 week and 6 month after their treatment decision. The PET versus surgery DESI may be used for any women who are considering this treatment choice. The chemotherapy versus no chemotherapy DESI may be used for any women who are considering this treatment choice. For women who are not offered either choice, the DESI will not be used. 9. Relating only to women entered into the study by a proxy decision maker because they lack cognitive capacity: the proxy decision maker will be offered access to the DESIs as part of the normal counselling process in intervention sites (and normal counselling in control sites). These proxy decision makers will be invited to complete optional questionnaires and take part in an interview about the counselling process. Previous inclusion criteria: 1. Female 2. Aged over 70 years of age at the time of diagnosis of cancer 3. Primary operable (TNM categories: T1 (Tumour 2 cm or less in greatest dimension), T2 (Tumour more than 2 cm but not more than 5 cm in greatest dimension), T3 (Tumour more than 5 cm in greatest dimension), N0 (No regional lymph node metastasis), N1 (Metastasis in movable ipsilateral axillary lymph node(s), M0 (No distant metastasis)) invasive breast cancer (core biopsy or diagnostic incision biopsy) 4. Tumour ER and Her-2 status will be available and categorised according to accepted scoring systems e.g. H score 6 or Allred score 57 for ER and for Her-2, IHC score 1-3 plus FISH testing if IHC equivocal 5. Ability to give informed consent if considering full or partial trial participation (see below) 6. Willing to complete the questionnaires for the additional trial evaluations if considering full trial participation 7. If suitable for data collection only, the patient does not need to give consent but participation in the data collection exercise should be agreed and assented to by their next of kin, friend or carer |
| Key exclusion criteria | 1. Disease unsuitable for surgery e.g. inoperable or metastatic disease 2. Previous invasive breast cancer (within past 5 years) 3. There is no restriction for people who are unable to speak English. Translation of study documents and translators will be undertaken by recruiting centres if required 4. For patients considered for the PET versus surgery comparison, use of concurrent Hormone Replacement Therapy (HRT) or therapy with any other oestrogen-containing preparation is an exclusion criteria, unless treatment is discontinued for 4 weeks before the study starts 5. There is no restriction for any co-morbidity or frailty as the study aims to capture data on management and outcomes in these cases 6. Patient without capacity being considered for the data collection only arm of the study but for whom there is no consultee available |
| Date of first enrolment | 01/04/2013 |
| Date of final enrolment | 31/05/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Doncaster
DN2 5LT
United Kingdom
Sheffield
S10 2JF
United Kingdom
Barnsley
S75 2EP
United Kingdom
Milton Keynes
MK6 5LD
United Kingdom
Scunthorpe General Hospital
DN33 2BA
United Kingdom
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Burnley
BB10 2PQ
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Prescot
L35 5DR
United Kingdom
Scarborough Hospital
York
YO31 8HE
United Kingdom
Liverpool
L7 8XP
United Kingdom
Keighley
BD20 6TD
United Kingdom
Leeds
LS9 7TF
United Kingdom
Bradford
BD5 0NA
United Kingdom
Llandough
CF64 2XX
United Kingdom
Nevill Hall Hospital, Abergavenny
Newport
NP18 3XQ
United Kingdom
Furness General Hospital
Lancaster
LA1 4RP
United Kingdom
Coventry
CV2 2DX
United Kingdom
Grantham and District Hospital
Pilgrim Hospital Boston
Lincolnshire
LN2 5QY
United Kingdom
Hull
HU16 5JQ
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Southport
PR8 6PN
United Kingdom
Crewe
CW1 4QJ
United Kingdom
The Royal Marsden, Sutton Surrey
London
SW3 6JJ
United Kingdom
Cheltenham General Hospital
Gloucester
GL1 3NN
United Kingdom
London
SE1 9RT
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Chelmsford
CM1 7ET
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Bristol
BS10 5NB
United Kingdom
Chesterfield
S44 5BL
United Kingdom
Rotherham
S60 2UD
United Kingdom
Dartford
DA2 8DA
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Colchester
CO3 3NB
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Croydon
CR9 2RS
United Kingdom
Stockton on Tees
TS19 8PE
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Luton
LU4 0DZ
United Kingdom
Weston-super-Mare
BS23 4TQ
United Kingdom
Ashton-under-Lyne
OL6 9RW
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Wigan
WN1 2NN
United Kingdom
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Manchester
M23 9LT
United Kingdom
Liverpool
L9 7AL
United Kingdom
Birmingham
B18 7QH
United Kingdom
Brighton
BN1 6AG
United Kingdom
The Plain
Epping
CM16 6TN
United Kingdom
Parkhurst Road
Newport
PO30 5TG
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Office
C Block
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
England
United Kingdom
"ROR" |
https://ror.org/01yc93g67 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 21/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The datasets generated and/or analysed during the current study are available from Ms Lynda Wyld (l.wyld@sheffield.ac.uk) on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No | |
| Results article | results | 10/06/2015 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | results | 01/09/2015 | Yes | No | |
| Results article | results | 01/12/2015 | Yes | No | |
| Results article | results | 01/01/2021 | 23/11/2020 | Yes | No |
| Results article | results on quality of life in patients undergoing chemotherapy | 01/02/2021 | 30/12/2020 | Yes | No |
| Results article | 01/07/2021 | 12/05/2021 | Yes | No | |
| Other publications | Intervention development and usability testing | 14/01/2019 | 30/11/2022 | Yes | No |
| Other publications | Process evaluation | 13/07/2021 | 30/11/2022 | Yes | No |
| Results article | 27/05/2021 | 30/11/2022 | Yes | No | |
| Results article | 01/06/2022 | 30/11/2022 | Yes | No | |
| Plain English results | 14/03/2025 | No | Yes |
Editorial Notes
11/06/2025: The overall study end date was changed from 28/02/2019 to 30/05/2026.
14/03/2025: Link to Cancer Research UK plain English results added.
03/01/2024: Publication reference added.
30/11/2022: Publication references added.
12/05/2021: Publication reference added.
30/12/2020: Publication reference added.
23/11/2020: Publication reference and total final enrolment number added.
15/10/2018: The following changes have been made:
1. The study hypothesis has been changed.
2. The study design has been changed from "Observational cohort study" to "Observational cohort study with nested cluster randomised controlled trial".
3. The intervention has been changed.
4. The secondary outcome measures have been changed.
5. The overall trial end date has been changed from 21/10/2017 to 28/02/2019.
6. The participant inclusion criteria have been changed.
7. The recruitment end date has been changed from 31/08/2017 to 31/05/2018.
8. St Margaret’s Hospital, St Mary’s Hospital, Churchill Hospital and Frimley Park Hospital have been added as trial centres.
9. The plain English summary has been changed.
18/10/2017: Internal review.
