Trial of an app to support breast cancer survivors prescribed hormone therapy
| ISRCTN | ISRCTN51581601 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51581601 |
| Secondary identifying numbers | 38697 |
- Submission date
- 08/10/2018
- Registration date
- 09/10/2018
- Last edited
- 22/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Hormone therapy (HT) is prescribed to breast cancer survivors after they have completed primary treatment. It can significantly reduce the risk of breast cancer recurrence and mortality. However, many women do not take their treatment as prescribed, which is known as non-adherence. This leads to significantly increased risk of recurrence and mortality. Despite sub-optimal levels of adherence and the importance of adherence in clinical outcomes, no studies have attempted to improve adherence to tamoxifen. This study will test a digital intervention (app) which has been developed and tested as part of a previous study, where it was shown to be acceptable and had the potential to improve adherence.
Who can participate?
Women diagnosed with primary breast cancer who have been prescribed hormonal therapy within the last three years
What does the study involve?
Phase 1 is a large questionnaire study to investigate predictors of non-adherence and uptake of the intervention. From there, participants are invited into phase 2 and randomly allocated to the intervention or wait-list control group. Participants in the intervention group receive access to the app and work through the 6 sessions over a 9 week period. The app aims to provide information on how HT works and why women have been prescribed it; to help women develop strategies to remember to take HT; to address any concerns associated with HT; and to help women to manage their side effects. Participants also receive two telephone support sessions from a researcher. Participants in the wait list control group receive access to the app after 12 months. All participants complete questionnaires at the start of the study and 9 weeks, 6 months and 12 months later to measure adherence to treatment.
What are the possible benefits and risks of participating?
The results will establish the effectiveness of this intervention at improving adherence and supporting patients with the treatment. Participants should benefit by taking part as they will receive access to the app which has been designed to help them with their treatment and to improve their adherence and their quality of life. There is very little risk involved in participating. A participant could become distressed after reading the information about their treatment. They will be encouraged to discuss their concerns with their healthcare team and will be referred to support services.
Where is the study run from?
1. Pinderfields Hospital
2. Pontefract Hospital
3. Dewsbury and District Hospital
4. Huddersfield Royal Infirmary
5. Calderdale Royal Hospital
6. Darlington Memorial Hospital
7. Bishop Auckland General Hospital
8. University Hospital of North Durham
9. City Hospital
10. Tameside General Hospital
11. Wythenshawe Hospital
12. Macclesfield District General Hospital
13. Burnley General Hospital
14. Royal Blackburn Hospital
15. Conquest Hospital
16. Eastbourne District General Hospital
17. Whittington Hospital
18. St Albans City Hospital
19. University College Hospital
20. Barnet Hospital
21. Chase Farm Hospital
22. Royal Free Hospital
23. Bronglais General Hospital
24. Withybush General Hospital
25. Prince Philip Hospital
When is the study starting and how long is it expected to run for?
January 2018 to July 2021
Who is funding the study?
Breast Cancer Now
Who is the main contact?
Dr Zoe Moon
zoe.moon@kcl.ac.uk
Contact information
Scientific
5th Floor Bermondsey Wing
Guy’s Hospital
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-5242-1718 |
|---|---|
| Phone | +44 (0)207 188 0179 |
| zoe.moon@kcl.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Cross-sectional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised controlled trial of an app-based digital intervention to support breast cancer survivors prescribed hormone therapy (e-path study) |
| Study acronym | e-path study |
| Study hypothesis | The aim of the trial is to assess the effectiveness of an app to improve adherence and secondary outcomes including quality of life in breast cancer survivors prescribed hormone therapy. The app was developed and piloted as part of a previous study (16/LO/1205). The results from the pilot study showed the intervention was acceptable, and that it had the potential to improve adherence. |
| Ethics approval(s) | Approved 16/11/2018, London - City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT; +44(0)207 1048058; nrescommittee.london-cityandeast@nhs.net), ref: 18/LO/1674. |
| Condition | Breast cancer |
| Intervention | There are two phases to the current study. Phase one: A large questionnaire study of around 2000 women will measure adherence and a range of psychosocial variables. Patients will be recruited from outpatient clinics across the UK. Eligible patients will be identified by clinic staff and given an information sheet as well as verbal information about the study. They will be encouraged to contact the research team if they have any questions. The questionnaire can be completed in clinic or at home either as a paper version or online. Informed consent will be taken before the patient completes the questionnaire. Participants who are not eligible for phase 2 will be followed up at 6 and 12 months with a short questionnaire to establish if it is possible to identify who will later become non-adherent using the psychosocial measures collected at baseline. Phase two: Women from phase one who are eligible (n=220) will be invited into the RCT to test the effectiveness of the digital intervention. Patients will be randomised 1:1 into the intervention or wait list control conditions. Patients in the wait list control condition will receive access to the intervention materials at 12 months follow up. All patients will complete a questionnaire pack at 9 weeks, 6 months and 12 months post randomisation. Patients in the intervention group will receive access to the app and will work through the 6 sessions over a 9 week period. They will receive two telephone support sessions from a researcher. At 9 weeks and 12 months, a proportion of the intervention group will be invited to take part in a qualitative study to discuss their experiences of the intervention. The 12 month follow up will be a qualitative online survey. |
| Intervention type | Other |
| Primary outcome measure | Adherence, measured using the MARS. Women be classified as adherent or non-adherent based on their scores on the MARS; Timepoint(s): baseline, 9 weeks, 6 months and 12 months. |
| Secondary outcome measures | 1. Beliefs about hormone therapy, measured using BMQ-AET 2. Illness perceptions, measured using IPQ-BCS 3. Distress, measured using PHQ2, GAD7 4. Quality of life, measured using FACT-B 5. Side effects, measured using BCPT Symptom checklist 6. Satisfaction with information about treatment measured using The Satisfaction with Information about Medicines Scale (SIMS) 7. Self-efficacy for managing symptoms measured using a modified version of a standard self-efficacy scale 8. Perceived behavioural control measured using 4 items from a Theory of Planned Behaviour questionnaire All measures are collected at baseline, 9 weeks, 6 months and 12 months |
| Overall study start date | 08/01/2018 |
| Overall study end date | 31/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 2000; UK Sample Size: 2000 |
| Participant inclusion criteria | Phase one: 1. Diagnosed with primary breast cancer 2. Prescribed hormonal therapy within the last three years Phase two: 1. ≤23 on the MARS 2. Has weekly access to smartphone or tablet 3. Has email address |
| Participant exclusion criteria | 1. Diagnosed with secondary or metastatic cancer 2. Prescribed duration of hormonal therapy is due to come to an end during trial 3. Current treatment for depression or psychiatric disorders 4. Not fluent in verbal and written English Phase two: 1. Diagnosed with secondary or metastatic cancer 2. Prescribed duration of hormonal therapy is due to come to an end during trial 3. Current treatment for depression or psychiatric disorders 4. Not fluent in verbal and written English 5. Patient does not provide consent or refuses to be randomised 6. Patient is currently taking part in another trial |
| Recruitment start date | 08/01/2019 |
| Recruitment end date | 21/12/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
SE1 9RT
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Pontefract
WF8 1PL
United Kingdom
Dewsbury
WF13 4HS
United Kingdom
Huddersfield
HD3 3EA
United Kingdom
Halifax
HX3 0PW
United Kingdom
Darlington
DL3 6HX
United Kingdom
Bishop Auckland
DL14 6AD
United Kingdom
Durham
DH1 5TW
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Ashton-under-Lyne
OL6 9RW
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Burnley
BB10 2PQ
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Hastings
St Leonard's-on-Sea
TN37 7RD
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
London
N19 5NF
United Kingdom
St Albans
AL3 5PN
United Kingdom
Fitzrovia
London
NW1 2BU
United Kingdom
Barnet
EN5 3DJ
United Kingdom
Enfield
EN2 8JL
United Kingdom
Hampstead
London
NW3 2QG.
United Kingdom
Aberystwyth
SU23 1ER
United Kingdom
Haverfordwest
SA61 2PZ
United Kingdom
Dafen
Llanelli
SA14 8QF
United Kingdom
Sponsor information
University/education
c/o Prof. Reza Razavi
Room 5.31
James Clerk Maxwell Buidling
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)20 7848 3224 |
|---|---|
| reza.razavi@kcl.ac.uk | |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BCN
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Main study outcomes will be published in a high impact peer reviewed journal in 2020. |
| IPD sharing plan | Reasonable requests for data will be can be made to the principal investigator for consideration. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/06/2020: The IPD sharing statement has been changed from "The data sharing plans for the current study are unknown and will be made available at a later date." to "Reasonable requests for data will be can be made to the principal investigator for consideration." and the participant level data updated accordingly.
12/07/2019: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 02/01/2019 to 08/01/2019.
25/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Breast Cancer; Health Category: Cancer and neoplasms" to "Breast cancer" following a request from the NIHR.
