Objective: Up to 50% of breast cancer survivors prescribed tamoxifen do not take it as prescribed for the full duration, which is linked to increased risk of recurrence and mortality. This paper tests the feasibility and acceptability of a self-directed psychoeducational intervention to support medication taking. Design: A single arm pre–post design was used with 33 women with suboptimal adherence to tamoxifen (scores ⩽ 24 on the Medication Adherence Rating Scale, range 5–25) taking part in the intervention over 2–12 weeks. Method: Feasibility was assessed via eligibility, uptake and retention. Questionnaires were completed pre- and post-intervention, and qualitative interviews were conducted to assess acceptability of the materials. Results: Recruitment and uptake were good, with 87% of eligible participants agreeing to participate. Two thirds of participants recruited to the study completed the follow-up questionnaires (66%). The qualitative interviews showed that the participants found the materials acceptable and helpful. Paired samples t-tests showed small improvements in adherence over time, as well as improvements in psychosocial targets of the intervention, namely; necessity and concern beliefs, personal control, coherence, distress, symptom experience and self-efficacy for managing side-effects. Conclusion: The intervention appears to be acceptable and feasible in this population and has the potential to improve both adherence and quality of life in breast cancer survivors prescribed tamoxifen. Larger scale trials are needed however to establish the efficacy of the materials.
ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4–7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%–89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.
There is a lack of guidance for developing progression criteria (PC) within feasibility studies. We describe a process for co-producing PC for an ongoing feasibility study. Patient contributors, clinicians and researchers participated in discussions facilitated using the modified Nominal Group Technique (NGT). Stage one involved individual discussion groups used to develop and rank PC for aspects of the trial key to feasibility. A second stage involving representatives from each of the individual groups then discussed and ranked these PC. The highest ranking PC became the criteria used. At each stage all members were provided with a brief education session to aid understanding and decision-making. Fifty members (15 (29%) patients, 13 (25%) researchers and 24 (46%) clinicians) were involved in eight initial groups, and eight (two (25%) patients, five (62%) clinicians, one (13%) researcher) in one final group. PC relating to eligibility, recruitment, intervention and outcome acceptability and loss to follow-up were co-produced. Groups highlighted numerous means of adapting intervention and trial procedures should ‘change’ criteria be met. Modified NGT enabled the equal inclusion of patients, clinician and researcher in the co-production of PC. The structure and processes provided a transparent mechanism for setting PC that could be replicated in other feasibility studies.
Aim: To explore the lived experience of delivering or receiving news about an unborn or newborn child having a condition associated with a learning disability in order to inform the development of a training intervention for healthcare professionals. We refer to this news as different news. Background: How healthcare professionals deliver different news to parents affects the way they adjust to the situation, the wellbeing of their child and their ongoing engagement with services. This is the first study that examined the lived experience of delivering and receiving different news, in order to inform the development of training for healthcare professionals using the Theoretical Domains Framework version 2. Method: We conducted qualitative interviews with a purposive sample of 9 different parents with the lived experience of receiving different news and 12 healthcare professionals who delivered different news. It was through these descriptions of the lived experience that barriers and facilitators to effectively delivering different news were identified to inform the training programme. Data analysis was guided by Theoretical Domains Framework version 2 to identify these barriers and facilitators as well as the content of a training intervention. Findings: Receiving different news had a significant impact on parents’ emotional and mental wellbeing. They remembered how professionals described their child, the quality of care and emotional support they received. The process had a significant impact on the parent–child relationship and the relationship between the family and healthcare professionals. Delivering different news was challenging for some healthcare professionals due to lack of training. Future training informed by parents’ experiences should equip professionals to demonstrate empathy, compassion, provide a balanced description of conditions and make referrals for further care and support. This can minimise the negative psychological impact of the news, maximise psychological wellbeing of families and reduce the burden on primary care services.
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