"Until the trial is complete you can't really say whether it helped you or not, can you?": exploring cancer patients' perceptions of taking part in a trial of acupressure wristbands.

BACKGROUND: Nested qualitative studies within clinical trials provide data on patients' experiences of receiving trial interventions and can inform and improve trial designs. The present study explored patients' experiences of participating in a randomised controlled trial of acupressure wristbands for chemotherapy related nausea. METHODS: A randomised three-group sham-controlled trial was carried out to evaluate the effectiveness of acupressure wristbands in the management of chemotherapy-related nausea. A convenience sample of 26 patients volunteered to participate in a qualitative study to explore their experiences of using acupressure wristbands, and taking part in the clinical trial. Participants were recruited from each of the three UK geographical sites from which the trial was conducted: Manchester, Liverpool and Plymouth. In-depth semi-structured interviews were conducted with the participants in their own homes or other location convenient for participating patients. Interviews were audio-taped, transcribed verbatim and analysed using Framework methodology. RESULTS: The main motivational factors influencing participants to take part in the trial were a desire to 'give something back' and limit their own experience of nausea. Participants were largely satisfied with the organisation and running of the acupressure wristband trial. Many participants experienced positive outcomes as a result of taking part in the trial. Lapses in memory, or poor health as a result of their chemotherapy treatment, led to some participants failing to complete trial paperwork on designated days. Two sham wristband participants reported wearing the bands inappropriately resulting in pressure being applied to the acupoint. Almost all of the participants interviewed had only experienced mild nausea or vomiting during the trial. Participants were pragmatic on the extent to which the wristbands were responsible for this lack of nausea and vomiting during the trial. However, many participants, including some patients receiving sham acupressure, believed the wristbands to have had a positive impact on their nausea and vomiting; there was a perception that the wristbands were, at least in part, responsible for the lack of nausea and vomiting they had experienced. CONCLUSIONS: Participants perceive acupressure wristbands as reducing the level of nausea and vomiting experienced during chemotherapy treatment. Reports that some participants wore wristbands inappropriately, and/or delayed completion of trial paperwork could represent confounding variables and have implications for the trial results, and the design of clinical trials within the field of cancer

Barriers to Accessing Primary Dental Care in Adults with Alcohol Dependence: A Qualitative Study

Background:People with alcohol dependence (AD) frequently experience oral health problems, but their dental attendance is poor, with limited evidence to the reasons why from their perspective.Objective:To explore perceived barriers, motivators, and facilitators to accessing primary dental care in people with AD.Methods:Qualitative study consisting of remote one-to-one and group semistructured interviews with a convenience sample of adults with lived experience of AD in northern England. Data were audio-recorded, transcribed, and coded. A reflexive thematic analysis method was used; use of COM-B model informed data interpretation.Results:Twenty adults with lived experience of AD participated in 18 one-to-one interviews and 1 group interview (of 3 participants). Barriers to access were fear and physical, social, and environmental factors (physical effects of AD, financial barriers, nonprioritization of oral health). Motivators to access were pain and prioritization of oral health. Facilitators to access were patterns of alcohol use (i.e., sobriety) and dental service provision within recovery services.Conclusions:Fear of “the dentist” is a major barrier to accessing dental care, and pain is the primary motivator, among people with AD, although neither are unique to this population. Fear and physical, social, and environmental barriers to access contribute to problem-oriented attendance, which negatively affect oral health outcomes. Opportunity to facilitate attendance increases when a person is in remission from AD through their physical capabilities improving. Increasing capability and opportunity can influence attendance beyond the automatic motivation of pain. Provision of dental care within recovery services could facilitate access to care. Understanding the “web of causation” is key to developing any intervention to improve dental access in people with AD. Further research is needed from the perspective of other adult populations with lived experience of AD, as well as of dental professionals, to gain deeper insight into barriers, facilitators, and possible solutions

Feasibility and acceptability of combining cognitive behavioural therapy techniques with swallowing therapy in head and neck cancer dysphagia

Background: Head and neck cancer squamous cell carcinoma (HNSSC) patients report substantial rates of clinically significant depression and/or anxiety, with dysphagia being a predictor of distress and poorer quality of life. Evidence-based dysphagia interventions largely focus on the remediation of physical impairment. This feasibility study evaluates an intervention which simultaneously uses a psychological therapy approach combined with swallowing impairment rehabilitation. Methods: This prospective single cohort mixed-methods study, recruited HNSCC patients with dysphagia, from two institutions. The intervention combined Cognitive Behavioural Therapy with swallowing therapy (CB-EST), was individually tailored, for up to 10 sessions and delivered by a speech and language therapist. Primary acceptability and feasibility measures included recruitment and retention rates, data completion, intervention fidelity and the responsiveness of candidate outcome measures. Measures included a swallowing questionnaire (MDADI), EORTCQLQH&N35, dietary restrictions scale, fatigue and function scales and the Hospital Anxiety and Depression Scale (HADS), administered pre-, post-CB-EST with three month follow-up and analysed using repeated measures ANOVA. Qualitative interviews were conducted to evaluate intervention processes. Results: A total of 30/43 (70%) eligible patients agreed to participate and 25 completed the intervention. 84% were male, mean age 59 yrs. Patients were between 1 and 60 months (median 4) post-cancer treatment. All patients had advanced stage disease, treated with surgery and radiotherapy (38%) or primary chemoradiotherapy (62%). Pre to post CB-EST data showed improvements in MDADI scores (p = 0.002), EORTC-QLQH&N35 (p = 0.006), dietary scale (p < 0.0001), fatigue (p = 0.002) but no change in function scales or HADS. Barriers to recruitment were the ability to attend regular appointments and patient suitability or openness to a psychological-based intervention. Conclusions: CB-EST is a complex and novel intervention, addressing the emotional, behavioural and cognitive components of dysphagia alongside physical impairment. Preliminary results are promising. Further research is required to evaluate efficacy and effectiveness

The effectiveness and cost-effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea: Assessment of Nausea in Chemotherapy Research (ANCHoR), a randomised controlled trial

Chemotherapy-induced nausea and vomiting remain difficult symptoms to manage in clinical practice. As standard antiemetic drugs do not fully eliminate these symptoms, it is important to explore the adjuvant role of non-pharmacological and complementary therapies in antiemetic management approaches. Acupressure is one such treatment showing highly suggestive evidence so far of a positive effect, meriting further investigation

RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial

Background: There are over 25 million people worldwide living with or beyond cancer and this number is increasing. Cancer survivors face a range of problems following primary treatment. One of the most frequently reported and distressing symptoms experienced by cancer survivors is fatigue. There is growing support for survivors who are experiencing problems after cancer treatment to engage in supported self-management. To date there is some evidence of effective interventions to manage fatigue in this population; however, to our knowledge there are no online resources that draw on this information to support self-management of fatigue. This paper describes the protocol for an exploratory randomized controlled trial of an online intervention to support self-management of cancer-related fatigue after primary cancer treatment.Methods/design: This is a parallel-group two-armed (1:1) exploratory randomized controlled trial including 125 cancer survivors experiencing fatigue (scoring ≥4 on a unidimensional 11-point numeric rating scale for fatigue intensity) within five years of primary treatment completion with curative intent. Participants will be recruited from 13 NHS Trusts across the UK and randomized to either the online intervention (RESTORE), or a leaflet comparator (Macmillan Cancer Backup, Coping with Fatigue). The primary outcome is a change in Perceived Self-Efficacy for Fatigue Self-Management (as measured by the Perceived Self-Efficacy for Fatigue Self-Management Instrument). Secondary outcomes include impact on perception and experience of fatigue (measured by the Brief Fatigue Inventory), and quality of life (measured by the Functional Assessment of Cancer Therapy - General and the Personal Wellbeing Index). Outcome measures will be collected at baseline, 6 weeks (completion of intervention), and 3 months. Process evaluation (including telephone interviews with recruiting staff and participants) will determine acceptability of the intervention and trial processes.Discussion: Data from this trial will be used to refine the intervention and contribute to the design of an effectiveness trial. This intervention will be expanded to address other cancer-related problems important to cancer survivors following primary cancer treatment

Self-management programmes in temporomandibular disorders: results from an international Delphi process

Self-management (SM) programmes are commonly used for initial treatment of patients with temporomandibular disorders (TMD). The programmes described in the literature, however, vary widely with no consistency in terminology used, components of care or their definitions. The aims of this study were therefore to construct an operationalised definition of self-management appropriate for the treatment of patients with TMD, identify the components of that self-management currently being used and create sufficiently clear and non-overlapping standardised definitions for each of those components. A four-round Delphi process with eleven international experts in the field of TMD was conducted to achieve these aims. In the first round, the participants agreed upon six principal concepts of self-management. In the remaining three rounds, consensus was achieved upon the definition and the six components of self-management. The main components identified and agreed upon by the participants to constitute the core of a SM programme for TMD were as follows: education; jaw exercises; massage; thermal therapy; dietary advice and nutrition; and parafunctional behaviour identification, monitoring and avoidance. This Delphi process has established the principal concepts of self-management, and a standardised definition has been agreed with the following components for use in clinical practice: education; self-exercise; self-massage; thermal therapy; dietary advice and nutrition; and parafunctional behaviour identification, monitoring and avoidance. The consensus-derived concepts, definitions and components of SM offer a starting point for further research to advance the evidence base for, and clinical utility of, TMD SM

Patient and caregiver experiences of living with dementia in Tanzania

Introduction: Tanzania is a low-income country with an increasing prevalence of dementia, which provides challenges for the existing healthcare system. People with dementia often don’t receive a formal diagnosis, and with a lack of formal healthcare, are often predominantly supported by family relatives. There are very few published data relating to lived experiences of people with dementia in Tanzania. This study aimed to understand people with dementia, and their caregivers’ experiences of living with dementia in Tanzania and the perceived needs of people with dementia. Methods: Qualitative, semi-structured interviews were conducted with 14 people with dementia and 12 caregivers in Moshi, Tanzania. Interviews were audio-recorded, translated, transcribed and analysed using a Framework Analysis approach. Results: Three sub-themes were identified within data describing the experience of ‘Living with Dementia in Tanzania’: ‘Deteriorations in Health’, ‘Challenges to living with Dementia in Tanzanian Culture’, and ‘Lack of Support’: people with dementia faced challenges due to social isolation, stigmatisation, and lack of caregiver knowledge on how best to provide support. Collectively, these impacted on both the physical and mental health of people with dementia. Misconceptions about dementia aetiology related to age, stresses of daily life and other co-morbidities. People with dementia were motivated to access treatment, exhibiting pluralistic health-seeking behaviours. There was an overall preference for non-pharmacological interventions over medication, with high levels of trust in medical professional opinions. Conclusions: Living with dementia in Tanzania is influenced by both cultural and religious factors. More work is needed to target supplementary healthcare (with efforts to promote accessibility), support for caregivers and public health education about dementia to overcome existent misconceptions and stigma

A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial

. A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial. Supportive Care in Cancer, Results One hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [−0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested