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Trial of an app to support breast cancer survivors prescribed hormone therapy

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51581601
Enrollment
2000
Registered
2018-10-09
Start date
2019-01-08
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

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 r

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026