The YCR ACTION trial: A case study
Research type
Research Study
Full title
The Yorkshire Cancer Research ACTION Trial, study 2, Case Study: Testing the delivery and acceptability of an ACT-based intervention for women with breast cancer to support well-being and hormone therapy medication decisions.
IRAS ID
254444
Contact name
Sam Smith
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Study Support CRN Yorkshire and Humber, EDGE ID: 122537
Duration of Study in the UK
0 years, 7 months, 5 days
Research summary
Research Summary
Women with oestrogen receptor positive breast cancer who have finished their primary, hospital-based treatment (e.g. chemotherapy/surgery) and have been prescribed adjuvant Hormone Therapy (HT) often suffer unpleasant side effects and a reduced quality of life. They also find that support is lacking at this stage in their cancer journey. This can cause women not to take their medication as frequently as prescribed, which therefore increases their risk of a cancer recurrence and mortality. Together with breast cancer patients and clinicians working in oncology, we have developed a psychological intervention based on Acceptance and Commitment Therapy (ACT). This intervention aims to provide support during this difficult time, to help women cope with the side effects of HT (and thus make taking medication less of a burden), and subsequently help women to continue to take their medication as prescribed, with an improved quality of life. Six - ten women who have finished their active breast cancer treatment and have been prescribed HT will take part in the intervention. The intervention will consist of one individual session of ACT (lasting 1 hour), followed by three group sessions (lasting 1.5 hours), delivered by clinical psychologists. The group sessions will take place fortnightly in a hospital. Participants will also be directed to a secure website which will contain: ACT exercises, educational information on managing side effects, signposting, information to give to others (e.g. family, work), returning to work, patient stories (videos), information on psychological and emotional issues. A focus group with participants will then take place, along with interviews of clinicians, to gather feedback on the intervention and check whether anything needs changing. Then, the intervention will be tested in a subsequent study for feasibility, via a randomised control pilot trial.
Summary of Results
Thank you to all study participants for taking part, and to the clinicians and research teams at our participating NHS site.
This study was funded by Yorkshire Cancer Research, and was carried out by the University of Leeds. The ACTION intervention was delivered by Mid Yorkshire Hospitals NHS Trust during February and March 2020. The study and intervention was co-developed in a previous set of studies involving focus groups, interviews, and a workshop, with women with lived experience of breast cancer and hormone therapies, along with healthcare professionals involved in their care (e.g. nurses, oncologists, clinical psychologists).
Aim
The main aim of this case study was to identify any problems with the training, delivery, or evaluation of the ACTION intervention. The secondary aims were to collect data on whether 1) participants found the intervention and trial acceptable and feasible to take part in; and 2) whether healthcare professionals who delivered the intervention found it acceptable and feasible to deliver within the NHS setting. This research was needed to inform a further (larger) pilot trial of the ACTION intervention.Intervention
Seven women with breast cancer who were prescribed adjuvant endocrine therapy (hormone therapies, such as tamoxifen or aromatase inhibitors) and who had completed their primary hospital-based treatments, took part in the ACTION case study. The ACTION intervention consists of one individual in-person session with a clinical psychologist followed by three in-person group sessions with a clinical psychologist. They are also given a workbook to work through at home and in sessions, audio recordings to practice learnt skills to, and a website containing patient stories and strategies to self-manage side-effects of treatment. The intervention is based on Acceptance and Commitment Therapy (ACT): the in-person sessions focus on improving ‘psychological flexibility’ through exercises such as noticing their thoughts and feelings, accepting rather than avoiding them, and distancing themselves from their worries. The aims of the ACTION intervention are to reduce distress, increase quality of life, improve self-management of medication side-effects, and help women make decisions about taking their hormone therapies that are in line with their values.
Participants completed questionnaires before and after the intervention, and were invited to provide feedback in an interview with a researcher.Results
All seven participants received one individual in-person session with a clinical psychologist. Five of the seven participants also took part in the first in-person group session with a clinical psychologist. The remaining two group sessions were cancelled due to the COVID-19 pandemic and government mandated lockdown. However we were still able to gather feedback on the acceptability and feasibility of the ACTION intervention through telephone interviews and questionnaires.Four participants and one clinical psychologist took part in follow up telephone interviews with a researcher from the University of Leeds. One further clinical psychologist provided feedback via a short feedback form.
Participant feedback
Of the participants who took part in the interviews, two of them attended only the individual session, and two attended the individual and the first group session. All participants thought it was a shame that it could not continue, and that three group sessions sounded like the right amount. The individual session before the group sessions was viewed positively. They all found talking to someone useful and gave positive feedback about the psychologists who delivered the sessions.The two participants who were interviewed who had attended the group sessions found it useful to hear from other women in a similar situation to them. It helped them normalise their experiences and feelings, and they found it useful to hear about different ways of coping.
Participants had not used the website much (or at all), but thought that it may be useful for them to go back and look at when experiencing any bothersome side-effects.
Feedback on the questionnaires was that they were long, but that because they were tick-box questions it was okay to complete them all. Furthermore, despite some sensitive questions, they did not mind answering them as they understood that it would help the research, and they knew that they could leave them out if they wanted to.The sign up process was reported as being fine, as was attending in person, despite one mention of having to arrange time off work and paying for parking at the hospital site.
Clinical psychologist feedback
The feedback from the clinical psychologists delivering the intervention was that the intervention itself was acceptable, feasible, and that the content was valuable for patients. More time for patient discussion was a suggestion for improving the group sessions, along with a higher number of participants (8) to ensure the group sessions are feasible to deliver in the NHS. Some improvements were also suggested for the recruitment process (to be made simpler and clearer) and other study management processes, for example the timing of the clinician intervention training sessions.This study has informed us of what worked well, and what improvements can be made to the ACTION intervention, delivery, and trial management. These findings will inform the next stage, which is to run a pilot trial of it, with 80 participants recruited from five NHS hospital sites.
REC name
Wales REC 5
REC reference
19/WA/0278
Date of REC Opinion
27 Sep 2019
REC opinion
Favourable Opinion