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Table 1 Eligibility criteria for participation in the ACTION trial

From: Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial

1. Written (signed and dated) informed consent

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 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). Women are still eligible for the study before completing Herceptin.

8. Currently prescribed oral adjuvant Hormone Therapy (tamoxifen, raloxifene, 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

12. The participant is willing and able to access all sessions remotely via video call

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) research study where medication adherence is a primary outcome

3. Those who are unable to access the sessions remotely via a video call

4. Currently attending, or on a waiting list for psychotherapy/psycho-oncology/psychology/counselling services, for any reason (related to medication or not)

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. clinical team are aware that 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,

(i) Recently (in the last month), have you had any thoughts about ending your life? *

(ii) Have you thought about how you might go about it?

(iii) Do you intend to carry out this plan?

* a patient is only excluded if they answer ‘yes’ to question 6 (iii)