The Yorkshire Cancer Research ACTION pilot trial of Acceptance and Commitment Therapy for women with breast cancer to support wellbeing and hormone therapy medication decisions

Not Applicable

Completed

Conditions: Cancer
Malignant neoplasm of breast
Breast cancer

Registration Number: ISRCTN12027752

Lead Sponsor: niversity of Leeds

Brief Summary: 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35135619/ (added 10/02/2022) 2024 Results article in https://doi.org/10.1002/pon.6349 (added 20/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 79

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

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?