Condition category
Cancer
Date applied
08/10/2018
Date assigned
09/10/2018
Last edited
09/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zoe Moon

ORCID ID

http://orcid.org/0000-0002-5242-1718

Contact details

5th Floor Bermondsey Wing
Guy’s Hospital
London
SE1 9RT
United Kingdom
+44 (0)207 188 0179
zoe.moon@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38697

Study information

Scientific title

Randomised controlled trial of an app-based digital intervention to support breast cancer survivors prescribed hormone therapy (e-path 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

London – City and East, ref: 18/LO/1674 - approval pending

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Breast Cancer; Health Category: Cancer and neoplasms

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

Phase

Drug names

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 trial start date

08/01/2018

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 2000; UK Sample Size: 2000

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

02/01/2019

Recruitment end date

21/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy’s Hospital (lead centre)
London
SE1 9RT
United Kingdom

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Pontefract Hospital
Friarwood Lane
Pontefract
WF8 1PL
United Kingdom

Trial participating centre

Dewsbury and District Hospital
Halifax Road
Dewsbury
WF13 4HS
United Kingdom

Trial participating centre

Huddersfield Royal Infirmary
Acre St
Huddersfield
HD3 3EA
United Kingdom

Trial participating centre

Calderdale Royal Hospital
Salterhebble
Halifax
HX3 0PW
United Kingdom

Trial participating centre

Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

Trial participating centre

Bishop Auckland General Hospital
Cockton Hill Rd
Bishop Auckland
DL14 6AD
United Kingdom

Trial participating centre

University Hospital of North Durham
North Road
Durham
DH1 5TW
United Kingdom

Trial participating centre

City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Tameside General Hospital
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Burnley General Hospital
Casterton Avenue
Burnley
BB10 2PQ
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Conquest Hospital
The Ridge Hastings
St Leonard's-on-Sea
TN37 7RD
United Kingdom

Trial participating centre

Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Whittington Hospital
Magdala Ave
London
N19 5NF
United Kingdom

Trial participating centre

St Albans City Hospital
Waverley Road
St Albans
AL3 5PN
United Kingdom

Trial participating centre

University College Hospital
235 Euston Road Fitzrovia
London
NW1 2BU
United Kingdom

Trial participating centre

Barnet Hospital
Wellhouse Lane
Barnet
EN5 3DJ
United Kingdom

Trial participating centre

Chase Farm Hospital
127 The Ridgeway
Enfield
EN2 8JL
United Kingdom

Trial participating centre

Royal Free Hospital
Pond St Hampstead
London
NW3 2QG.
United Kingdom

Trial participating centre

Bronglais General Hospital
Caradoc Road
Aberystwyth
SU23 1ER
United Kingdom

Trial participating centre

Withybush General Hospital
Fishguard Road
Haverfordwest
SA61 2PZ
United Kingdom

Trial participating centre

Prince Philip Hospital
Bryngwyn Mawr Dafen
Llanelli
SA14 8QF
United Kingdom

Sponsor information

Organisation

King’s College London and Guy’s and St Thomas’ NHS Trust

Sponsor details

c/o Prof. Reza Razavi
Room 5.31
James Clerk Maxwell Buidling
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)20 7848 3224
reza.razavi@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Breast Cancer Now; Grant Codes: 2017MayPR881l

Alternative name(s)

BCN

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Main study outcomes will be published in a high impact peer reviewed journal in 2020.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes