Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The study will evaluate four intervention components in a pilot trial with a nested process evaluation recruiting women with early stage (1-3a) breast cancer who have been prescribed hormone therapy.
Sponsors
University of Leeds
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/01/2023: 1. An informed consent form (signed and dated) 2. Capacity to provide informed consent 3. Women with early stage (1 to 3a) breast cancer according to the TNM / American Joint Committee on Cancer (AJCC) staging system. Note. Women being treated for a second primary breast cancer or a breast cancer local recurrence are eligible for the study, providing the most recent cancer is being treated with adjuvant endocrine therapy, and they meet all eligibility criteria. Women with bilateral breast cancer are permitted, providing at least one breast is affected by hormone receptor-positive disease’ 4. Aged =18 years at time of screening for ROSETA’s pilot study 5. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required 6. Treated with curative intent 7. Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months. Note. Women are still eligible for the study if they are being treated with monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo 8. Currently prescribed oral adjuvant Hormone Therapy (tamoxifen, raloxifene, anastrozole, letrozole, exemestane) 9. The participant is willing to complete the study questionnaires* 10. The participant is willing to be audio recorded during the therapy sessions* 11. The participant is willing and able to attend all ACT sessions either via video conference or telephone* 12. The participant is willing and able to complete home practice tasks* 13. Access to a mobile phone to receive SMS messages* 14. Willing to receive frequent SMS messages* 15. Access to a computer or smart device that can access the internet* *Source data for these items will be either partially or completely patient self-report. Previous inclusion criteria: 1. An informed consent form (signed and dated) 2. Capacity to provide informed consent 3. Women with early-stage (1 to 3a) breast cancer according to the TNM / American Joint Committee on Cancer (AJCC) staging system. 4. Aged =18 years at time of screening for ROSETA’s pilot study 5. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required 6. Treated with curative intent 7. Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months. 8. Currently prescribed oral adjuvant Hormone Therapy (tamoxifen, raloxifene, anastrozole, letrozole, exemestane) 9. The participant is willing to complete the study questionnaires 10. The participant is willing and able to attend all ACT sessions either via video conference or telephone. 11. The participant is willing and able to complete home practice tasks 12. Access to a mobile phone to receive frequent SMS messages 13. Willing to receive frequent SMS messages 14. Access to a computer or smart device that can access the internet
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 10/01/2023: 1. Stopped taking adjuvant hormone therapy if it is clinically contraindicated according to clinical recommendation 2. Women with metastatic breast cancer 3. Currently or recently (last 6 months) involved in a similar research study where medication adherence is a primary outcome* 4. Currently attending psychotherapy/psycho-oncology/psychology/counselling services, for any clinical reason* 5. Need for treatment for a severe mental health disorder or crisis, which is likely to interfere with participation (e.g., active psychosis, bipolar disorder, significant issues with addiction or self-harm or expressing active suicidal ideation with active plans and intent*) Note, if concerned about the possible presence of risk of suicidal ideation with active plans and intent, then this can be assessed with the following questions, with patients ineligible if they answer ‘yes’ to 5.3. Recently (in the last month): 5.1. Have you had any thoughts about ending your life? 5.2. (if yes) Have you thought about how you might go about it? 5.3. (if yes) Do you intend to carry out this plan? 6. Patients with a scheduled date for breast reconstruction surgery that is within their intervention delivery and follow-up period. Note: Women planning to have a breast reconstruction but who have not scheduled a date for surgery are permitted 7. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips* *Source data for these items will be either partially or completely patient self-report. Previous 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 a similar research study where medication adherence is a primary outcome 3. Currently or recently (last month) been referred to a psycho-oncology service 4. Currently attending, or on a waiting list for, psychotherapy/psycho-oncology/psychology/counselling services, for any reason 5. Current diagnosis of an active major mental health disorder likely to interfere with participation (e.g., active psychosis, significant issues with addiction, or self-harm) 6. Known element of risk (e.g. the clinical team is aware that the patient has made a recent attempt to end their life, or has recently disclosed plans to do so) as determined by three clinical screening questions below: 6.1. Recently (in the last month), have you had any thoughts about ending your life? 6.2. Have you thought about how you might go about it? 6.3. Do you intend to carry out this plan? 7. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eligibility, recruitment, retention and follow up rates, as well as availability and feasibility of outcome and process data, to inform the design of the optimisation phase of the ROSETA project, will be measured using data on the following, collected throughout the duration of the recruitment, intervention and at 2 and 4 months post-randomisation: 1. Number of patients identified as potentially eligible 2. Number and proportion of patients approached for eligibility screening 3. Number and proportion of patients agreeing to detailed eligibility screening and reasons for non-agreement 4. Number and proportion of eligible patients out of those potentially eligible and reasons for ineligibility 5. Number and proportion of patients consenting to randomisation out of those eligible and reasons for non-randomisation 6. Number of participants randomised per site per month 7. Questionnaire completion rates at each time-point 8. Number of items of missing data per questionnaire at each time-point 9. Number and proportion of randomised participants lost-to-follow-up 10. Number, proportion, type, and timing of participant withdrawals out of those randomised and reasons for withdrawal 11. Number and proportion of participants with successful linkage to NHS Digital prescribing and/or dispensing data 12. Number and proportion of participants completing adherence questionnaires (MMAS-8 and Voils DOSE) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the intervention to participants and establish intervention component adherence measured using the following: 1.1. Short Message Service (SMS) text receipt at 2 and 4 months 1.2. Self-reported receipt and reading of information leaflet at 4 months 1.3. Receipt of website log in details and website use 2 and 4 months 1.4. ACT session attendance (clinician reported) between randomisation and 4 weeks 1.5. ACT module content engagement (clinician reported) between randomisation and 4 weeks 1.6. ACT module content engagement (patient reported) between randomisation and 4 weeks 1.7. Acceptability Questionnaire at 4 months 1.8. Qualitative interviews with participants and therapists at the end of the study 2. Estimate of the variability of planned outcome measures measured using the following: 2.1. NHS prescribing and/or dispensing data at all timepoints 2.2. Morisky adherence measure at all timepoints 2.3. Voils DOSE-Nonadherence measure- Extent Scale all timepoints 3. Estimate of the cost of developing and delivering each intervention component measured using NHS Reference Costs and Personal Social Services Research Unit cost data at the end of the study 4. Levels of burden among patients and healthcare professionals delivering intervention components measured using the following: 4.1. Acceptability Questionnaire at 4 months 4.2. Trial experience questionnaire (SPFQ) across all time points 4.3. Qualitative interviews with participants and therapists at the end of the study SWAT: 1. Questionnaire response rates and completeness measured using the following: 1.1. Proportion of participants in each SWAT group who return the questionnaire within 96 h, 7 days, and 1 month of them being administered 1.2. Number of days between the questionnaire being sent to participants and it being returned by participants to the research team 1.3. Proportion of non-mandatory questionnaire items missing at all timepoints 1.4. Proportion of non-mandatory questionnaire m | — |
Countries
United Kingdom
Contacts
Public ContactRachel Ellison
Outcome results
None listed