ABSTRACT
Background: Little is known about patients’ interactions with Supported Self-Management (SSM) for early breast cancer (EBC), or confidence in managing their care in this pathway. The PRAGMATIC study allowed us to explore these issues. Methods: Three clinical teams in Surrey and Sussex identified EBC patients due to enter SSM. Patients completed standardised questionnaires (separately reported) +/- semi-structured telephone interviews at baseline, 3, 6, 9 and 12 months. The interviews explored how confident patients felt managing their care, accessing services, managing side effects (SEs), and lifestyle changes. Results: 32/110 patients engaged in interviews;data are available for 30/32 at all timepoints. Participants were representative of the whole group in terms of demographics and treatment received. Patients understood the main reasons for SSM were to: a) assume responsibility for their follow up (18/32;56%) and b) save time and money for them and the hospital (16/32;50%). Most maintained (very/somewhat) confidence over time in managing their care and SEs, but were less confident identifying BC related signs/symptoms especially if screen detected. 19 patients contacted the SSM helpline +/- their GP. 15/19 found the helpline easy to use and 6/19 were seen by a healthcare professional. The main triggers for calling were for advice on signs/symptoms and managing SEs. 5/26 (19%) patients on endocrine therapy (ET) had stopped it completely. Most (29/32) were engaged in exercise before diagnosis, and 8/10 who discontinued during treatment resumed afterwards. The COVID-19 pandemic had a negative impact on exercise and socialising. The interviews’ free text provided a plethora of rich data. Qualitative analysis produced four overarching themes: 1) expectations and experiences, 2) emotional wellbeing, 3) clinical concerns, and 4) effect of COVID-19 pandemic. Conclusions: SSM works for most EBC patients. Clinicians could explain that the helpline is available for psychosocial as well as physical concerns. BC teams may want to review how to help screen detected patients recognise BC related signs/symptoms, how to monitor adherence to ET and offer interventions for treatment related SEs. Clinical trial identification: ISRCTN10777283. Legal entity responsible for the study: University of Sussex. Funding: Surrey & Sussex Cancer Alliance. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background Cognitive-behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.