Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The format of the intervention being evaluated was co-developed with both potential participants (women with breast cancer) and healthcare professionals involved in their care. It was co-designed thro
experiencing medication problems
or retrospective screening)
3. Participant age (=50 years
51-69 years
or >70 years)
Participants will be identified and screened from breast cancer services at eligible NHS Trust Hospitals. There will be three recruitment routes for patients to the pilot study:
1.The r
Sponsors
University of Leeds
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Written (signed and dated) informed consent 2. Capacity to provide informed consent 3. Women with early stage (1 to 3a) breast cancer 4. Aged > = 18 years at the time of screening for ACTION 5. Have sufficient proficiency in English to contribute to the therapy sessions and data collection required. 6. Treated with curative intent 7. Completed their hospital-based treatment (e.g. surgery, radiotherapy and/or chemotherapy) 8. Currently prescribed oral adjuvant Hormone Therapy (tamoxifen, anastrozole, letrozole, exemestane) 9. The participant is willing to be audio recorded during the therapy sessions 10. The participant is willing to complete the study questionnaires 11. The participant is willing and able to attend all intervention sessions and/or complete therapy workbook
Exclusion criteria
Exclusion criteria: 1. Stopped taking adjuvant hormone therapy if it is clinically contraindicated according to clinical recommendation 2. Currently or recently (last 6 months) involved in another psychotherapy (e.g. using CBT/ACT, mindfulness etc.) research study where medication adherence is a primary outcome 3. Currently attending, or on a waiting list for psychotherapy/psycho-oncology/psychology/counselling services, for any reason (related to medication or not) 4. Known element of risk (e.g. clinical team are aware that patient has made a recent attempt to end their life, or has recently disclosed plans to do so). Three questions from the C-SSRS will be used at the point of screening to rule out risk: 4.1. Recently (in the last month), have you had any thoughts about harming yourself or ending your life? (If a patient responds ‘yes’ to question 1 and ‘no’ to question 2 & 3 they will still be eligible) 4.2. Have you thought about how you might go about it? 4.3. Do you intend to carry out this plan?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Eligibility, recruitment, retention and follow up rates to inform the design of a phase III RCT will be measured using the following patient data collected from study sites for the duration of the recruitment and the intervention periods and at 3, and 6 months: 1.1. Number of patients screened for eligibility 1.2. Number and proportion of patients eligible out of those screened and reasons for ineligibility 1.3. Number and proportion of patients who consent out of those eligible and reasons for non-consent 1.4. Number and proportion of patients consenting to randomisation out of those eligible and reasons for non-randomisation 1.5. Number of participants randomised per site per month 1.6. Questionnaire completion rates at each time-point 1.7. Number of items of missing data per questionnaire at each time-point 1.8. Number and proportion of randomised participants lost-to-follow-up 1.9 Number, proportion, type, and timing of participant withdrawals out of those randomised and reasons for withdrawal | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the intervention and protocol to participants and NHS therapists assessed using the following: 1.1. Intervention adherence for patients in the intervention arm (number of sessions attended, number of participants in the group sessions, whether homework was completed, and reasons for non-attendance / non-compliance) measured using patient data collected from study sites for the duration of the recruitment and the intervention periods and at 3, and 6 months 1.2. Website use including the number of website visits throughout the trial, pages visited, materials downloaded, videos watched, and clicked links measured from data collected by the website server during the intervention period 1.3. Number of patients deemed as having completed the intervention (minimum exposure is defined as attending the individual session and at least one of the three group sessions) measured using patient data collected from study sites during the intervention period 1.4. Treatment as usual content in both arms from participants (number of sessions attended and content of sessions) and sites (initiatives implemented during trial) measured using patient data collected from study sites during the intervention period 1.5. Safety (deaths and hospitalisations related to the trial intervention recorded until the end of the study) measured using patient data collected from study sites for the duration of the intervention period and at 3, and 6 months 1.6. Acceptability of the ACTION intervention to participants measured using the Acceptability Questionnaire at 6 months 1.7. Acceptability of the ACTION intervention to participants measured using the B&N questionnaire (used for the acceptability progression criteria) at 6 months 1.8. Number, proportion, and timing of therapist withdrawals and reasons for withdrawal measured using data provided at the time of withdrawal 1.9. Acceptability of the intervention and RCT procedures and which (if any) intervention components were helpf | — |
Countries
England, United Kingdom
Outcome results
None listed