Supporting Women with adhErence to hormonE Therapy following breast cancer (SWEET): the feasibility study

Improving outcomes for women diagnosed with early breast cancer through adherence to adjuvant endocrine therapy: the feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29401613

Enrollment

Registered

2022-08-12

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-05-04

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

Conditions

Breast Cancer Cancer

Interventions

Sub-study 1 is a single-arm, non-randomised feasibility study to explore the acceptability and feasibility of delivering the SWEET intervention (HT&Me support package). Recruited women (n=45) will rec

Eligibility

Sex/Gender

Female

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Sub-study 1 Inclusion criteria: The following patients will be eligible: 1. Aged 18 years old and over 2. Female 3. Diagnosis of ER-positive invasive breast cancer 4. Medium or high risk of recurrence, defined as one of the following: 4.1. T2 and N0 4.2. T2 and N>0 4.3. T1 and N>0 4.4. T1 and N0 and grade 3 5. Within 3 months of first oral adjuvant endocrine therapy (AET) prescription (tamoxifen or aromatase inhibitor) 6. Completed surgery 7. Completed chemotherapy (if applicable) 8. Can access the internet and have an email address 9. Are willing to use a support package with a web-based component Sub-study 2 Inclusion criteria: The following patients will be eligible: 1. Aged 18 years old and over 2. Female 3. Diagnosis of ER-positive invasive breast cancer 4. Medium or high risk of recurrence, defined as one of the following: 4.1. T2 and N0 4.2. T2 and N>0 4.3. T1 and N>0 4.4. T1 and N0 and grade 3 5. Were first prescribed oral AET (tamoxifen or aromatase inhibitor) within the past 9-36 months 6. Have completed surgery 7. Have completed chemotherapy (if applicable)

Exclusion criteria

Exclusion criteria: Sub-study 1 and 2 exclusion criteria: The following patients with early-stage ER+ve invasive breast cancer will be ineligible: 1. Male 2. Have been prescribed adjuvant CDK4/6i (abemaciclib) 3. Have cognitive impairment sufficient to preclude participation, as judged by the clinical team 4. Are unable to read and understand English 5. Had previous AET (for another breast cancer) 6. Have not had surgery for breast cancer

Design outcomes

Primary

Measure	Time frame
Sub-study 1: 1. Optimal patient recruitment pathways measured using patient and health care provider (HCP) interviews at around 8-9 weeks post initial consultation and by review of patient screening logs recorded at time of assessment of eligibility 2. Feasibility of recruiting women to receive the intervention measured using patient and HCP interviews at around 8-9 weeks post initial consultation and by review of: 2.1. Patient screening logs recorded at the time of assessment of eligibility 2.2. Information recorded on reasons why women declined to take part (decliner log), recorded at the time of recruitment 3. Feasibility of delivering the intervention measured as percentages of recruited women who: 3.1. Received the initial nurse consultation within 8 weeks of recruitment 3.2. Accessed the web app during their time in the study, determined from the questionnaire and analytic data at 8-9 weeks post initial consultation and from HCP interviews at 8-9 weeks post initial consultation 4. Acceptability and usefulness of the HT&Me intervention to patients measured using patient and HCP interviews at around 8-9 weeks post initial consultation 5. Barriers to, and facilitators of, trial implementation, including: 5.1. Willingness of staff to recruit women to a randomised controlled trial (RCT) measured using HCP interviews at around 8-9 weeks post initial consultation 5.2. Willingness of women to be recruited and randomised to an RCT measured using patient interviews and follow-up questionnaire at around 8-9 weeks post initial consultation 6. Test processes for collecting self-reported outcome data measured using patient questionnaires at baseline and at 8 weeks after the initial consultation Sub-study 2: 7. Test processes for obtaining prescription encashment data for a small cohort of women with breast cancer initially prescribed adjuvant endocrine therapy some months previously measured retrospectively using prescription data from NHS digital or GP records, collected	—

Measure

Time frame

Sub-study 1: 1. Optimal patient recruitment pathways measured using patient and health care provider (HCP) interviews at around 8-9 weeks post initial consultation and by review of patient screening logs recorded at time of assessment of eligibility 2. Feasibility of recruiting women to receive the intervention measured using patient and HCP interviews at around 8-9 weeks post initial consultation and by review of: 2.1. Patient screening logs recorded at the time of assessment of eligibility 2.2. Information recorded on reasons why women declined to take part (decliner log), recorded at the time of recruitment 3. Feasibility of delivering the intervention measured as percentages of recruited women who: 3.1. Received the initial nurse consultation within 8 weeks of recruitment 3.2. Accessed the web app during their time in the study, determined from the questionnaire and analytic data at 8-9 weeks post initial consultation and from HCP interviews at 8-9 weeks post initial consultation 4. Acceptability and usefulness of the HT&Me intervention to patients measured using patient and HCP interviews at around 8-9 weeks post initial consultation 5. Barriers to, and facilitators of, trial implementation, including: 5.1. Willingness of staff to recruit women to a randomised controlled trial (RCT) measured using HCP interviews at around 8-9 weeks post initial consultation 5.2. Willingness of women to be recruited and randomised to an RCT measured using patient interviews and follow-up questionnaire at around 8-9 weeks post initial consultation 6. Test processes for collecting self-reported outcome data measured using patient questionnaires at baseline and at 8 weeks after the initial consultation Sub-study 2: 7. Test processes for obtaining prescription encashment data for a small cohort of women with breast cancer initially prescribed adjuvant endocrine therapy some months previously measured retrospectively using prescription data from NHS digital or GP records, collected

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026